Norton Rose Fulbright's Food Safety Blog

Canadian food fight: Producers combatting grocery discounts with minimum advertised pricing plans

2014-04-22T08:00:00.000-05:00

With intense competition among retail grocery chains, food manufacturers are increasingly being confronted by demands to freeze or roll-back the prices at which they sell to retailers. This is, in part, due to the lower margins earned when retailers aggressively discount products to drive store traffic. Using popular brands as so-called "loss leaders" can often cause conflicts between retailers and suppliers, particularly if the brand is positioned in the market as a premium or high quality brand. Suppliers are typically loathe to see the brand equity in which they have invested diminished when their products are heavily discounted.

When Canada's Competition Act was amended in 2009, suppliers gained a new tool to address these concerns. Prior to the amendments, it was a criminal offence for a person engaged in the business of producing or supplying a product to, by certain specified means, attempt to influence upward, or to discourage the reduction of, the price at which any other person supplied, offered to supply, or advertised a product within Canada. A supplier could suggest a retail price, but had to make clear that the final decision on the retail price rested with the retailer and that the relationship between the supplier and retailer would not suffer if the retailer did not accept the suggestion.

Following the amendments, this conduct is no longer a criminal offence. Suppliers can now dictate retail prices, so long as doing so does not result, or is unlikely to result, in an adverse effect on competition.^[1] This threshold of anti-competitive harm is lower than the bar set in other provisions of the Competition Act, which require there be a substantial lessening of competition. Thus far, there has been little guidance provided on what constitutes an "adverse" effect, other than it is less than what is required for there to be a "substantial" effect. In Canada's Abuse of Dominance Provisions Enforcement Guidelines, the Commissioner of Competition has indicated that a market share of less than 35% will generally not prompt further investigation, and those provisions use the "substantial lessening" threshold.^[2]

A recent article in a major Canadian newspaper suggested that food suppliers are combatting pressure for discounts and price roll-backs by imposing minimum advertised pricing programs on grocery retailers.^[3] Under these programs, a supplier relies on section 76 of the Competition Act unilaterally to dictate the lowest price at which the retailers it supplies can advertise their products. Failure to follow these programs could, under the supply program, result in a range of specified sanctions, ranging from the loss of promotional funds up to the discontinuation of supply. Given these concerns, there have been calls for the federal government to impose a code of conduct on suppliers and retailers. Similar codes exist in Britain and Australia, where the grocery sector is highly concentrated.^[4] At a practical level, it is unclear which federal agency would be responsible for such a code, although it should be noted that the Competition Bureau issued abuse of dominance guidelines for the grocery sector in 2002. (Those were repealed (along with other sector-specific guidelines) when the current guidelines were issued in 2012.)

Suppliers considering a supply program that would impose minimum advertising pricing requirements should exercise caution and carefully evaluate their market position prior to implementing one. Suppliers that do not have a dominant position will generally be able to impose such programs, as it is unlikely that doing so will give rise to an adverse effect on competition. However, the analysis is highly fact-specific and should be undertaken with care. In addition, suppliers should only act unilaterally in imposing these programs. Acting in concert with other suppliers or at the behest of certain retailers could result in a breach of the criminal prohibition on price-fixing, which can result in a fine of up to $25 million and up to 14 years in jail.^[5]

¹Competition Act, s. 76.
²The Abuse of Dominance Provisions – Enforcement Guidelines (2012), section 2.3.1.
³Marina Strauss, “Canadian grocery suppliers strike back against heavy discounting,” The Globe and Mail, March 6, 2014 and “Grocers call for code of conduct between retailers, suppliers”, The Globe and Mail, March 7, 2014.
⁴Marina Strauss, “Grocers call for code of conduct between retailers, suppliers”, The Globe and Mail, March 7, 2014.
⁵Competition Act, s. 45.

Canada continues to expand livestock traceability systems: New national pig identification and traceability program

2014-04-17T08:00:00.000-05:00

Author Jenna Anne de Jong

On July 1, 2014, amendments to the Health of Animals Regulations will come into force, extending livestock traceability requirements to domestic pigs farmed for food production^[1]. The new regulations will allow for a formal agreement with a third-party administrator to create and sustain a database containing up-to-date information regarding the identification, movement and location of all pigs in Canada. The new amendments will be extended on July 1, 2015 to apply to farmed wild boars.

The traceability system is designed to improve food safety by minimizing the risk of a disease outbreak, and minimize the economic consequences of an outbreak of animal diseases through immediate access to complete and up-to-date information regarding pig identification, movement and location. Because the traceability system will require reporting on the movement of the pigs between sites, it is anticipated that this extra information will allow the Canadian Food Inspection Agency to react more quickly in the event of an animal disease outbreak. The new program will specify how and when pigs must be identified as well as how pig location and the movement of pigs must be reported. The administrator of the new program will issue identification numbers for pigs and will manage an information database. To minimize the impact on small producers, there will be circumstances in which pigs may be moved without requiring individual identification for each pig. However, pigs being transported directly for slaughter will need to be identified with an approved tag or a slap tattoo indicating a site number instead of a number unique for the particular pig.

Livestock traceability systems have been a focus for both the federal Ministry of Agriculture as well as the provincial and territorial ministries since 2009, and national traceability systems have already been implemented for cattle, bison and sheep. Although a voluntary pig traceability system has been in place for nearly five years through the Canadian Pork Council, regulators concluded that based on experiences in the United Kingdom, the Netherlands and France with both swine fever outbreak and foot-and-mouth disease, the voluntary system is inadequate to protect Canada swine population. As well, a voluntary program would not have full participation of the swine industry, then raising the risk of an untraceable animal disease outbreak. The Canadian Pork Council has indicated its support for the amendments to the regulations.

The new regulations address both the import as well as the export of pigs. Importers of pigs will be subject to reporting requirements and imported pigs will require an approved tag (or an acceptable equivalent tag from a foreign country) applied either before importation or as soon as the pig reaches its final destination. Exporters of pigs will also have reporting requirements and pigs will have to be identified in the manner required by the importing country.

Although some provinces already have provincial pig traceability systems in place, the new national system is intended to harmonize and consolidate this information across Canadian jurisdictions.

¹Regulations Amending the Health of Animals Regulations, SOR/2014-23, Canada Gazette Part II, Vol. 148, No. 5

FDA Warning Letter update

2014-04-14T08:00:00.000-05:00

Author Lidia Niecko-Najjum*

*Admitted to practice in Virginia; practice directly supervised by principals of the firm admitted in the District of Columbia.

The FDA issues Warning Letters to provide individuals and companies with an opportunity to take voluntary and prompt corrective actions for violations of regulatory significance that may otherwise lead to enforcement. A Warning Letter is the FDA's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act ("FDCA").

Below is a brief synopsis of FDA's food-related Warning Letters issued and posted between February 14, 2014 and March 14, 2014.

Warning Letters issued to dairies, veterinarians and animal dealers

FDA issued Warning Letters to five dairies that sold adulterated animals for slaughter as food: Erickson Dairy, LLC in Neillsville, WI; Falls View Farm in Richfield Springs, NY; Bridgewater Dairy, LLC in Montpelier, OH; Reyskens Dairy, LLC in Custer, OH; and the farm of Alex and Wayne Jackson in Union, ME.

Such food is deemed to be adulterated if 1) it bears or contains a new animal drug that is unsafe, and/or 2) the animal has been held under unsanitary conditions. Failure to maintain complete treatment records presumes the food to be held under unsanitary conditions.

The United States Department of Agriculture, Food Safety and Inspection Services (USDA/FSIS) examined tissue samples from the recipient dairies and found drug residue at each. These findings showed that the samples exceeded FDA's acceptable drug residue levels and these dairies failed to maintain complete animal treatment records.

In addition, it was found that the five dairies mentioned above also used drugs off-label. The off-label use of approved animal or human drugs in animals is allowed only if a licensed veterinarian within the context of a valid veterinarian-client/patient relationship prescribes it. Further, appropriate measures must be taken to assure that assigned timeframes for withdrawal before marketing are met and no illegal drug residues occur in any food-producing animal subjected to the extra-label use. However, no record of supervision by a licensed veterinarian was found at four of the dairies: the Erickson Dairy, LLC, Falls View Farm, Reyskens Dairy, LLC and Alex and Wayne Jackson's farm. Even though at the Bridgewater Dairy, LLC the extra-label use was prescribed by a vet, it did not meet the necessary withdrawal timeframes and, as a result, illegal drug residues were present.

Further, FDA issued a Warning Letter to Hometown Veterinary Care, PC in Fairfield ME, for the unsafe and adulterated use of drugs. Specifically, this veterinary practice failed to properly label medicine with the directions for use and with the necessary withdrawal period prior to marketing the meat and milk specified by the veterinarian.

FDA also issued a Warning Letter to an animal dealer, Wilton Black in Litchfield, ME, who sold adulterated animals for slaughter as food. Dealers of animals frequently introduce, or offer, adulterated animals for introduction into interstate commerce. Accordingly, dealers share the responsibility for violating the Federal FDCA. To avoid illegal residue violations for animal dealers, the FDA recommended for the dealer to 1) implement an identification system that establishes traceability to the source of the purchased animal, 2) implement a system to determine whether the animal has been medicated and with what drug(s) from the purchased animal's source, and 3) if the animal has been medicated, to implement a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue.

Warning Letters issued to seafood processing facilities

FDA issued Warning Letters to two seafood processing facilities for selling adulterated products under the seafood Hazard Analysis and Critical Control Point (HACCP) regulation: Pulmuone Foods USA, Inc. in Fullerton, CA and 17 Merrill Drive, LLC in Rockland, ME.

Under the HACCP regulation, a seafood processing facility must have an annually signed and dated HACCP plan. The HACCP plan must contain the appropriate "critical limits" which are measured and verified. These would include, for example, temperature control measures that are monitored with calibrated instruments, and a list of the food safety hazards of pathogens caused by time and temperature abuse, and undeclared allergens. A food safety hazard is defined as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption."

Seafood products at these two facilities were deemed adulterated because both failed to properly document, implement, and monitor their respective HACCP plans. Further, 17 Merrill Drive LLC violated Current Good Manufacturing Procedures (CGMP) for Human Food, 21 C.F.R. 110, because it failed to monitor: the cleanliness of food contact surfaces, the prevention of cross-contamination from insanitary objects, and the protection of food contact surfaces from adulteration with chemical, physical, and biological contamination. FDA found issues with steam condensation generated by the cooking process that was dripping from the ceiling into the raw area due to inadequate exhaust/ventilation; discolored and rusty ice chute; and cleaning hoses in direct contact with wet processing room floors in the raw and high risk areas when not in use.

Warning Letters issued to food processing facilities

FDA issued a Warning Letter to a food processing facility, Bluegrass Holdco, Inc. in Stamford, CT, for manufacturing adulterated food products and violating the CPMG for Human Food.

Investigators identified the presence of salmonella at the Bluegrass Holdco, Inc. and determined that the food products processed at this whey powder manufacturing facility were adulterated in that they have been "prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health."

The FDA noted that this was a repeated salmonella finding at this facility. While Bluegrass Holdco, Inc. had offered in its response that it had shut down and was thoroughly cleaning the facility, and had hired a third-party consultant to investigate the contamination problem, FDA replied that the response lacked further detail about the specific corrective actions the facility has taken or will take, and the explanation of their appropriateness.

Companies in receipt of a Warning Letter have 15 days to respond to the agency, in writing, to explain the steps taken to correct the violations. The FDA then evaluates the responses and, if needed, can take regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures.

More information can be found here.

Roos Foods plant shut down after listeria outbreak

2014-04-11T08:00:00.000-05:00

Author Megan Fanale Engel

On March 12, 2014, the Food and Drug Administration (FDA) shut down the plant of cheese manufacturer, Roos Foods, after an investigation linked a listeria outbreak to the manufacturer's Mexican cheeses.

In February, the FDA recalled various types of Mexican cheeses from the Kenton, Delaware-based plant after the agency determined that the cheeses may have been contaminated with Listeria monocytogenes, a bacteria that can cause serious and sometimes fatal infections in the elderly, young children, and others with weakened immune systems. Healthy individuals infected with listeria could suffer short-term symptoms, including fevers, headaches, nausea, stiffness, abdominal pain, and diarrhea. The bacteria may cause miscarriage and stillbirth among pregnant women.

The FDA recalled the cheese items after health inspectors found the bacteria in a sample of Cuajada en Terron, a type of fresh cheese curd, on sale in unlabeled, clear plastic bags at a Mega Mart in Manassas, Virginia. The FDA found that the bacteria-infected products were distributed at retail stores in Virginia, Washington, D.C., Maryland, Delaware, New Jersey, and New York. Further investigation revealed that at least eight people living in California or Maryland came down with listeria, and one of the individuals died after eating the manufacturer's cheese. All of the illnesses were diagnosed between August 1, 2013 and November 27, 2013.

When investigating the Roos Foods plant, investigators found that the roof of the plant leaked so badly that water poured onto cheese-processing equipment and cheese-storage tanks. The agency also discovered standing water near cheese vats, food residue found on already-cleaned equipment, deteriorated equipment, and milk storage tanks that were not properly capped to prevent contamination. The suspension of Roos Foods prevents the manufacturer from distributing any food products. The FDA will lift the suspension only if it determines that the plant's conditions will no longer reasonably lead to death or serious adverse health effects to individuals.

For more information, read:
FDA shuts down Roos Foods cheese plant over listeria outbreak
CDC: 1 dead, 7 others sickened by listeria traced to cheese
FDA Press Release

Interim final rule on FSMA whistleblower protections issued by OSHA

2014-04-08T08:00:00.000-05:00

Author Erin Close*

*Admitted only in the State of New York. Practice supervised by principals of the firm admitted in DC.

On February 13, 2014, the Occupational Safety and Health Administration (OSHA) posted its interim final rule regarding the employee protection provision of the Food Safety Modernization Act (FSMA). This provision, often known as the whistleblower provision, establishes procedures for handling employee complaints under section 402 of the FSMA, which was signed into law in January of 2011. Section 402 protects employees of covered entities who disclose information about a possible violation of the Food, Drug, and Cosmetic Act (FDCA) from retaliation by their employer. Covered entities are those "engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food."

Under the FSMA, the employee must have a reasonable belief that the covered entity is in violation of the FDCA. The rule elaborates on the FSMA's "reasonable belief" standard, which requires that the complainant hold both (1) a subjective, good-faith belief that the conduct violates the FDCA or related rule and (2) an objectively reasonable belief that the conduct violates the FDCA or related rule. Objective reasonableness is determined "based on the knowledge available to a reasonable person in the same factual circumstances with the same training and experience as the aggrieved employee." This standard is consistent with Administrative Review Board decisions in the context of Sarbanes-Oxley whistleblower complaints.

Procedurally, the OSHA rule provides the employee 180 days to file a complaint with the Secretary of Labor. Subsequently, written notice is provided to those named in the complaint, and a government investigation may follow. The Secretary may conduct an investigation only if the complainant has made a prima facie case showing that the projected activity was a contributing factor in the adverse employment action taken against him or her. Once the Secretary issues a summary of an investigation's findings, both complainant and respondent have 30 days to file objections to the findings and/or preliminary order issued by the Secretary and request a hearing before an administrative law judge.

Where the Secretary has determined that a violation has occurred, the Secretary can award the complainant preliminary reinstatement, affirmative action to abate the violation, back pay with interest, compensatory damages, and/or costs and attorney fees.

This rule highlights the need for companies in the food industry to have robust compliance systems, including procedures for employees to anonymously notify the organization of potential violations and training for supervisors regarding protected whistleblower conduct.

OSHA has invited the public to submit comments on the interim final rule. Individuals may submit comments electronically at the Federal eRulemaking Portal, via mail or facsimile. Comments must be submitted by April 14, 2014.

Feed industry groups request extension of comment period deadlines

2014-04-03T08:00:00.000-05:00

Author Lidia Niecko-Najjum*

*Admitted to practice in Virginia; practice directly supervised by principals of the firm admitted in the District of Columbia.

As indicated in the previous article, the U.S. Food and Drug Administration (FDA) reached a settlement agreement with the Center for Food Safety (CFS) and Center for Environmental Health that extended and staggered the deadlines for publishing final rules implementing the Food Safety Modernization Act. Another feature of the settlement was that original deadlines for the close of comment periods were no longer operative.

In response, feed industry groups requested for FDA to extend the comment period deadlines for three major proposed rules affecting the grain, feed and processing industry. On March 4-6, the National Grain and Feed Association (NGFA), the American Feed Industry Association (AFIA), the Pet Food Institute (PFI) and the National Renderers Association jointly requested to change comment period deadlines from March 31 to June 30, 2014 for the Animal Feed/Pet Food Proposed Rule and the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration Proposed Rule. The industry groups also requested a 90-day extension for the Draft Approach for Designating High-Risk Foods comment period.

These groups argued that FDA is no longer subject to a court-imposed deadline for closing the comment period, and the extension would provide the feed industry additional time to prepare comments on the significant and complex issues raised by the proposed rule.

On March 19, the FDA announced that it will grant comment-period extensions for two of the proposed rules that the feed industry groups requested: 1) a 90-day extension for the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration Proposed Rule (and the accompanying draft qualitative risk assessment) to June 30, 2014; and 2) a 45-day extension for the Draft Approach for Designating High-Risk Foods to May 22, 2014. However, the FDA informed that it will not extend the comment period for the Animal Feed/Pet Food Proposed Rule, because the agency plans to publish revised language for this proposed rule and for its companion Human Food Proposed Rule in early summer of 2014.

Implementation of Food Safety Modernization Act delayed further

2014-03-31T15:57:00.000-05:00

Author Katharine Taylor Larson

Heralded as the most sweeping change to food safety laws in half a century, the FDA has struggled to meet the Food Safety Modernization Act's (FSMA) rulemaking timeline. On February 20, 2014, the FDA obtained an agreement to extend several deadlines.

The agreement settles a lawsuit brought against the FDA in response to delayed rulemaking. The Center for Food Safety and the Center for Environmental Health sued the FDA in a California federal court on August 20, 2012, after the FDA failed to promulgate seven new rules as was required by the statute. The advocacy groups alleged that the FDA's hesitance violated FSMA, and the organizations sought relief in the form of a court-imposed promulgation schedule.

The federal district judge granted the requested relief, and ordered the FDA to finalize all seven rules by June of 2015. The FDA appealed the decision to the Ninth Circuit. Pursuant to the settlement agreement, the FDA will abandon its appeal in exchange for a new set of deadlines.

The new deadlines for the following rules are staggered, ranging from August 30, 2015, to May 31, 2016:

August 30, 2015:
Preventive Controls for Human Food (FSMA Sections 103(a) and 103(c))
Preventive Controls for Animal Food (FSMA Sections 103(a) and 103(c))

October 31, 2015:
Foreign Supplier Verification Program (FSMA Section 301(a))
Produce Safety Standards (FSMA Section 105(a))
Accreditation of Third Party Auditors (FSMA Section 307)

March 31, 2016:
Sanitary Transport of Food and Feed (FSMA Section 111)

May 31, 2016:
Intentional Contamination (FSMA Section 106(b))

These deadlines are not necessarily set in stone, as the FDA may receive yet another extension upon a showing of good cause or with the written consent of the Centers for Food Safety and for Environmental Health. For now, mark your calendars.

Center for Food Safety sues FDA over food additives

2014-03-28T08:00:00.000-05:00

Author Brandon Lee Crisp

The Center for Food Safety (CFS) recently filed a lawsuit against the U.S. Food and Drug Administration (FDA) over the FDA's regulation of food additives and its Generally Recognized as Safe (GRAS) program. According to the suit, the FDA has relied on a proposed rule over the last 15 years that has allowed food manufacturers to determine whether a food additive is safe enough to be included on the agency's list of "generally recognized as safe" ingredients. Ingredients not on the GRAS list require agency approval before they can be used in food. This proposed rule was not final when the FDA began accepting GRAS notices in 1998 and it still has not been finalized today.

In the complaint, the CFS asks the court to vacate the proposed rule and require that the FDA apply the previous GRAS rule. The previous rule required manufacturers to formally petition the FDA for approval of a new food additive as GRAS, and to support such a request with published studies. This petition process also required the FDA to notify the public and provide opportunity for comment before approving the additive's use. According to the suit, the FDA's conduct of relying on a proposed rule "indefinitely"—and not considering and responding to public comments in the process of finalizing the rule—violates the rule-making requirements of the Administrative Procedure Act.

The FDA states on its website that the agency evaluates GRAS notices and determines whether there is any information that raises questions about a substance's GRAS status. But the CFS claims that the FDA does not truly evaluate the data and no longer confirms that a GRAS substance is actually safe. The lawsuit also references a 2010 report from the U.S. Government Accountability Office that reached a similar conclusion, finding that "companies may determine a substance is GRAS without FDA's approval or knowledge."

According to the complaint, there are several additives currently on the GRAS list that pose serious health risks to consumers. Examples of unsafe additives include volatile oil of mustard (which may contain a potential carcinogen), the fat-substitute olestra (which has allegedly caused GI problems in consumers), and a fungus-based meat substitute mycoprotein (which may cause dangerous allergic reactions).

The case is Center for Food Safety v. Kathleen Sebelius, Secretary of U.S. Department of Health and Human Services, case number 1:14-cv-267, in the U.S. District Court for the District of Columbia.

FDA and First Lady collaborate on nutrition labeling makeover

2014-03-26T12:29:00.002-05:00

Author Cori Annapolen Goldberg

Nutrition labels have been required on packaged food for two decades, in order to help consumers better understand the nutritional values of foods and therefore make more healthy choices for themselves and their families. On February 27, 2014, the U.S. Food and Drug Administration (FDA) proposed an update for these nutrition labels in order "to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease." The release was announced at a White House event by First Lady Michelle Obama, Department of Health and Human Services Secretary Kathleen Sebelius, and FDA Commissioner Margaret Hamburg. The proposed updates reflect new dietary recommendations, consensus reports, and national survey data, such as the 2010 Dietary Guidelines for Americans, nutrient intake recommendations from the Institute of Medicine, and intake data from the National Health and Nutrition Examination Survey (NHANES). The FDA also considered extensive input and comments from a wide range of stakeholders.

The First Lady has been active in bringing about this change and is a collaborator on this project. One of Mrs. Obama's initiatives has been the "Let's Move" campaign to help address childhood obesity. It has four pillars: (1) offering parents the tools needed to make better decisions about their children's nutrition, (2) getting healthier foods into schools, (3) improving the accessibility and affordability of healthy foods, and (4) increasing physical activity by increasing opportunities for kids to play and move.

This proposed labeling change will help achieve the first pillar. Michelle Obama issued the following statement: "Our guiding principle here is very simple: that you as a parent and a consumer should be able to walk into your local grocery store, pick up an item off the shelf, and be able to tell whether it's good for your family…So this is a big deal and it's going to make a big difference for families all across this country."

The proposed label would now:

Require information about the amount of "added sugars" in a food product. The 2010 Dietary Guidelines for Americans states that intake of added sugar is too high in the U.S. population and should be reduced. The FDA proposes to include "added sugars" on the label to help consumers know how much sugar has been added to the product.
Update serving size requirements to reflect the amounts people currently eat. What and how much people eat and drink has changed since the serving sizes were first put in place in 1994. By law, serving sizes must be based on what people actually eat, not on what people "should" be eating.
Present calorie and nutrition information for the whole package of certain food products that could be consumed in one sitting.
Present "dual column" labels to indicate both "per serving" and "per package" calorie and nutrition information for larger packages that could be consumed in one sitting or multiple sittings.
Require the declaration of potassium and vitamin D, nutrients of which some people in the U.S. population are not getting enough, which puts them at a higher risk for chronic disease. Vitamin D is important for its role in bone health. Potassium is beneficial in lowering blood pressure. Vitamins A and C would no longer be required on the label, though manufacturers could declare them voluntarily.
Revise the Daily Values for a variety of nutrients such as sodium, dietary fiber, and Vitamin D. Daily Values are used to calculate the Percent Daily Value on the label, which helps consumers understand the nutrition information in the context of a total daily diet.
While continuing to require "Total Fat," "Saturated Fat," and "Trans Fat" on the label, "Calories from Fat" would be removed because research shows that the type of fat is more important than the amount.
Refresh the format to emphasize certain elements, such as calories, serving sizes, and Percent Daily Value, which are important in addressing current public health problems like obesity and heart disease.

To help consumers understand the proposed changes in the labeling practices, the agency provided the below infographics:

The changes proposed would impact all packaged foods except certain meat, poultry, and processed egg products, as those products are regulated by the U.S. Department of Agriculture's Food Safety and Inspection Service and not the FDA. The FDA is also proposing to make corresponding updates to the Supplement Facts label on dietary supplements where applicable.

Critics of the labeling proposal say that the changes are not enough and that it is important to also provide information about caffeine content and the percentage of whole grains and that the ingredient listing is also due to be updated. The nutrition labeling format has not been changed in eight years. The last change occurred in 2006 when trans fats information had to be declared on the label. This change prompted manufacturers to reduce partially hydrogenated oils (PHOs), the main source of trans fats, in their products. The agency recently took a stand against trans fats, issuing a preliminary determination that PHOs are no longer generally recognized as safe (GRAS).

The agency is accepting public comments on the proposed changes for 90 days. It will then review the feedback and decide whether or not to make changes. This process could take one year or longer. Once the FDA issues a final rule, it will likely give companies two years to change their package labeling.

Producers' safety tools expanded by the launch of the Reference Database for Hazard Identification

2014-03-20T08:00:00.000-05:00

Author Jenna Anne de Jong

The Reference Database Hazard Identification

On February 7, 2014, the Canadian Minister of Health announced the launch of the Reference Database for Hazard Identification ("RDHI"). The RDHI is a tool created to assist the food industry in developing food safety control plans, such as Hazard Analysis Critical Control Point ("HACCP") plans, and to comply with relevant legislation such as the Food and Drugs Act, the Food and Drug Regulations and, once in force, the Safe Food for Canadians Act.

Information available on the RDHI

The database facilitates the identification of food and food-borne hazards. Producers are able to access relevant food hazard information and are able to search food-borne dangers along different phases of the production chain: "Product Ingredients and Incoming Materials", "Processing Steps" and "Plant Layout (Cross Contamination Zone)".

The "Product Ingredients and Incoming Materials" section identifies hazards at the input stage of the manufacturing process. The "Processing Steps" section identifies potential hazards specific to the production stage and the "Plant Layout (Cross-Contamination)" section helps detect hazards associated with the layout and design of the building in which food is processed. Food producers are also able to access information about hazards, including the source of the hazard, its characteristics, where it may present itself, and methods of prevention.

Utilization of the RDHI by industry

Under Canadian law, producers are required to implement a variety of food safety control mechanisms. HACCP are plans that minimize the risk of contamination by identifying areas in the production process that are susceptible to hazards. The plans are guided by seven principles, each a step to limit food's exposure to hazards. The first principle is hazard analysis, which involves laying out a plan to identify all possible food safety hazards that could cause a product to be unsafe for consumption, and the measures that can be taken to control those hazards.

The second principle involves identifying critical control points, which are the points in the production process where an action can be taken to prevent, eliminate or reduce a food safety hazard to an acceptable level. The remaining principles are comprised of establishing critical limits, monitoring procedures, corrective actions, verification procedures and record keeping.

Federally-registered meat and poultry producers are required to implement HACCP plans, pursuant to the Meat Inspection Regulations, and are monitored by the Canadian Food Inspection Agency ("CFIA"). Federally-registered fish producers are required to implement quality control plans under the Quality Management Program ("QMP"), which adopts HACCP principles.

Although HACCP is not mandatory for federally-registered egg, dairy, honey, maple or processed food producers, it is a system that is strongly recommended by the CFIA and is regularly used in the food industry as a quality control mechanism even where the use of HACCP may not be formally required by law.

The RDHI will be useful to producers looking to evaluate the effectiveness and comprehensiveness of their existing food safety controls, or looking to develop new food safety controls.

FDA Warning Letter update

2014-03-17T08:00:00.000-05:00

Author Erin Close

*Admitted only in the State of New York. Practice supervised by principals of the firm admitted in DC.

Warning Letters issued to dairies

The FDA issued Warning Letters to six dairies for selling animals for slaughter that were adulterated. Under 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health. The recipient dairies were found to have introduced animals with unsafe levels of various drugs present in the animal's tissue into the food supply.

Each dairy was also found to have failed to maintain treatment records for their cows. The FDA asserted that this inadequate monitoring caused it to be more likely that medicated animals bearing potentially harmful drug residues would enter the food supply.

Finally, these six dairies were found to have used pharmaceuticals in their cows in a manner not allowed by regulations. One warning letter was issued to a seventh dairy only for violations relating to the extra-label use of animal pharmaceuticals. The extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. Most of the dairies were found to have administered drugs to cows without the supervision of a veterinarian.

Warning Letters issued to food-processing facilities

Three food-processing facilities were found by FDA inspectors to have violated the Current Good Manufacturing Procedures (CGMP) for Human Food, Title 21, Code of Federal Regulations, Part 110. The products, which included snack bars, pistachios and cheese, were deemed adulterated. All of these products were deemed adulterated under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] in that they have been "prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health."

The pistachio processing facility was found to be the source of an outbreak of salmonella. Employees at the facility were seen touching doors on which bird feces had dried and storage boxes that were resting on the floor prior to touching the product. Observed employees did not wash or sanitize their hands prior to resuming their work of hand-sorting the pistachio product.

The snack food processing facility failed to sanitize machinery in order to prevent contamination by allergens. Additionally, an unknown dark liquid was seen dripping from a central assembly unit into mixing bowls subsequently used for the manufacturing of sesame bars, and food utensils and cutting equipment being stored on a metal rack labeled "clean" were observed to have visible food residue on them after being washed.

Warning Letters issued to seafood processing facilities

Two seafood processing facilities were issued Warning Letters for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, codified at 21 CFR § 123. Because these facilities failed to properly implement their HACCP plans, their seafood products were rendered adulterated within the meaning of Section 402(a)(4) of the FD&C Act, 21 USC. § 342(a)(4). The facilities' HACCP plans lacked required procedures, or, for certain products did not exist at all. Additionally, the facilities failed to properly follow certain procedures listed in their HACCP plan.

Warning Letters issued to shell egg production facilities

The FDA issued Warning Letters to four shell egg processing facilities for violations of the Egg Safety Rule, codified at 21 C.F.R. 118. The FDA found the presence of salmonella enteritidis (SE) in the environmental samples of one of the warned producers. The other three facilities were found not to have properly implemented legally-required measures meant to prevent the same. Additional draft guidance regarding the Egg Safety Rule, meant to provide additional guidelines for compliance with the Rule, was proposed in August 2013.

FSMA updates for February 2014

2014-03-14T08:00:00.000-05:00

Authors Megan Fanale Engel and Lidia Niecko-Najjum*

*Admitted to practice in Virginia; practice directly supervised by principals of the firm admitted in the District of Columbia.

FSMA 2013 Annual Report to Congress regarding the use of mandatory recall authority

Section 206 of the Food Safety Modernization Act ("FSMA") requires the Department of Health and Human Services ("HHS") to submit a report to Congress regarding the use of the Food and Drug Administration's ("FDA") recall authority and any FDA advisories informing consumers that they should not consume certain articles of food. The FDA may issue a mandatory recall order once the agency first provides the party with an opportunity to stop distributing the potentially dangerous food product. If the responsible party fails to voluntarily recall or stop distributing the food product, the FDA may proceed under the mandatory recall authority provided to the agency in section 423 of the Federal Food, Drug and Cosmetic Act ("FDCA"). Prior to the enactment of the FSMA, the FDA had to rely on voluntary recalls or obtain a court order to remove dangerous food items from the food supply chain.

In the 2013 annual report to Congress regarding the use of the FDA's mandatory recall authority, the FDA reported that from FY 2011 through FY 2013, the FDA issued only one mandatory recall action. On February 13, 2013, the FDA allowed Kasel Associates Industries, Inc. ("Kasel") the opportunity to initiate a voluntary recall for some lots of Kasel's pet treats. Prior to this date, the FDA and Colorado state inspectors conducted numerous product tests on Kasel's pet treats and tested environmental samples from Kasel's facilities. The tests revealed that many of the environmental samples and all of the pet treats tested positive for Salmonella. In response to the investigations, Kasel voluntarily recalled certain lots of dog treats that had tested positive. Kasel did not, however, recall all pet treat products produced at the facility where the environmental samples had tested positive for Salmonella.

As a result, the FDA issued to Kasel the Notification of Opportunity to Initiate a Voluntary Recall letter on February 13, 2013 to Kasel requesting that the company recall all pet treat products produced at its facility for a certain period of time. On February 19, Kasel announced a voluntary recall of all pet treats produced at its facility for a certain period of time due to potential contamination of salmonella.

For more information, read the FDA's annual report regarding its mandatory recall authority under the FSMA.

FDA's draft approach to designating high-risk foods for which additional records are required

On February 4, the FDA issued a draft approach to identifying high-risk foods ("HRFs") under section 204(d)(2) of the FSMA, which requires the FDA to designate HRFs for which additional records must be maintained. The additional records for designated HRFs would allow the FDA to more quickly identify recipients of food when illnesses from food are possible.

Section 204(d)(2)(A) already requires that the designation of HRFs must be based on the following factors:

Known safety risks of a particular food;
Likelihood that a particular food has a high risk for contamination due to the nature of the processes used to produce the food;
The point in the manufacturing process at which the food contamination would occur;
Likelihood of contamination and steps taken to reduce that likelihood during the manufacturing process;
Likelihood that consuming a particular food would result in foodborne illness from contamination; and
Likely severity of foodborne illness from the particular food item.

The FDA's draft approach would use a decision analysis approach based on multiple criteria to identify foods that should be designated as HRFs. The approach would put the criteria identified in § 204(d)(2)(A) listed above into a risk model. The FDA would identify food and hazard pairings and allocate a total risk score for each defined criteria. If there are foods with multiple risk scores because they are associated with more than one hazard, the FDA would arrive at a total HRF score using each of the individual scores. Whether or not the food would then be included on the HRF list would depend on the total risk score for foods or food categories. Read a description of the particular approach.

The FDA invites public comments and any applicable scientific data regarding its draft approach. The comment period will remain open until April 7, 2014.

FSMA proposed rule on sanitary transportation of human and animal food

On January 31, the FDA issued a proposed rule on sanitary transportation of human and animal food under the FSMA. This proposed rule would require food transporters to use sanitary transportation practices to ensure safety of human and animal food. Specifically, the proposed rule applies to shippers, receivers and carriers who transport food in the United States by motor or rail vehicles, including shippers who initiate a shipment of food entering US commerce by motor or rail vehicles from abroad. The proposed rule would establish the criteria for safe food transportation for vehicles and transportation equipment; transportation operations; information exchange; training; records; and waivers.

The FDA proposed that the final rule would be effective 60 days after it is published. Small businesses—other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $25.5 million in annual receipts—would have to comply within two years after the publication of the final rule. Other businesses, not otherwise excluded from coverage, would have to comply within one year of the final rule publication. The comment period for the proposed rule is open through May 31, 2014.

Recent recalls due to misbranding and undeclared allergens

2014-03-11T08:00:00.000-05:00

Author Katharine Larson

In the past few weeks, the Department of Agriculture's Food Safety and Inspection Service (FSIS) announced the recall of chicken products due to various labeling issues. An Arkansas firm failed to mention the presence of wheat in chicken tenders, a Missouri firm's chicken salad did not properly declare a soy protein concentrate and chicken noodle soup was incorrectly labeled as chicken and rice soup by a Pennsylvania firm.

George's Incorporated, the Arkansas firm, recalled roughly 1.25 million pounds of frozen, pan-fried chicken tenders on January 27, 2014. The chicken products were taken off the market because wheat was not declared on the product labels due to printer error. The mislabeling was discovered by the company during a regular assessment, and the printing issues have been corrected. The recall carries a Class II categorization, indicating that there is a "remote possibility of adverse health consequences from the use of the product."

Walker's Food Products Company, the Missouri firm, recalled approximately 2,500 pounds of chicken salad products on January 30, 2014. "Walker's All White Chunky Chicken Salad" and "Walker's White Chicken Salad Florentine" contained a soy protein concentrate which was not identified on the label. The misbranding, which was discovered by a routine inspection conducted by FSIS, was attributed to a change in product suppliers. The FSIS deemed this a Class I recall because "there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death."

Finally, ConAgra Foods, the Pennsylvania firm, recalled almost 55,000 pounds of chicken noodle soup products on February 4, 2014. The chicken noodle soup product, containing wheat and egg, was inaccurately labeled with declarations pertaining to a chicken and rice soup. The labeling mix-up was discovered by consumers. This recall also merited a Class I classification.

As of this writing, no adverse reactions have been reported. FSIS is currently conducting recall effectiveness checks to ensure that consumers are notified and to confirm that the products are no longer available for purchase.

US House and Senate pass Farm Bill; President signs into law

2014-03-07T16:38:00.001-06:00

Author Lidia Niecko-Najjum

*Admitted to practice in Virginia; practice directly supervised by principals of the firm admitted in the District of Columbia.

On Friday, February 7, the country's latest Farm Bill was signed into law. The Agriculture Act of 2014 creates policy for the next five years but allocates government spending over the next ten.

The new Farm Bill includes the requirement that pork, chicken or beef sold in the US is labeled as to where the animals were born, slaughtered and processed; replaces direct crop payments (costing $5 billion in direct subsidies to farmers whether they grow their crops or not) with a revised and expanded crop insurance program that transfers the risk of the market to the government at times of poor harvests; fights soil erosion by forcing farmers who would like to receive subsidies to follow a series of conservation practices; protects more prairie land by cutting subsidies in half for farmers who farm on some virgin soil; and gives farmers incentives to grow certain crops, including corn and now sushi rice.

This Farm Bill allocates $956 billion in government spending over the next decade as follows:

$756 billion to the Supplemental Nutrition Assistance Program (SNAP)—cutting food stamps by more than $800 million a year (around one percent of the roughly $80 billion a year food stamp program);
$89.8 billion to crop insurance;
$56 billion to conservation;
$44.4 billion to commodity programs; and
$8.2 billion to "everything else."

According to the Congressional Budget Office, the latest Farm Bill will save approximately $16.6 billion overall.

In his remarks before signing the Farm Bill, President Obama announced a new "made in Rural America" initiative to help rural businesses market their goods abroad; White House officials also announced five regional forums on rural exports and an "investing in rural America" conference. President Obama directed the White House Rural Council to host sessions in all 50 states to train Department of Agriculture staff members on how to promote rural exports.

Food safety issues to watch in Canada in 2014

2014-02-18T08:00:00.000-06:00

Author Jenna Anne de Jong

Two reports released at the end of 2013 have raised concerns over Canada's food safety system and will require action by the Canadian Food Inspection Agency ("CFIA") in 2014.

In December 2013, the United States Food Safety and Inspection Service released the results of its most recent audit of Canada's food safety system. Canada's food safety system was found to be adequate, which is the lowest possible score to remain eligible to export food to the United States. Several areas were identified as needing improvements, including sanitation and humane handling. As previously reported in greater detail, Canada's Auditor General's Fall Report, released in November 2013, was also critical of certain elements of the CFIA's food recall procedures.

In 2014, the CFIA is also expected to continue working towards implementing the Safe Food for Canadians Act, SC 2012, c 24 (the "Act"). Passed in November 2012, the Act, which is intended to strengthen and modernize Canada's food safety system by drawing together all food inspection legislation into one cohesive and consistent law, has an anticipated coming into force date of early 2015, as stated on the CFIA website, although no date has been fixed by the Governor in Council. The CFIA is currently consulting with stakeholders in order to develop regulations to support the new Act.

Health Canada will begin consultation in 2014 on proposed changes to the list of maximum residue limits("MRLs") for veterinary drugs in foods. Under the Canadian Food and Drug Regulations, veterinary drugs must be authorized by Health Canada. Because drugs approved for use in a food-producing animal may result in residues of the drug remaining in tissues or products of treated animals, not all drugs are permitted for use in animals intended for consumption.

Health Canada sets the acceptable MRLs for veterinary drugs. These MRLs represent the maximum concentrations of residues recognized as safe by Health Canada, and are based on the type and amount of residue considered to pose no adverse health effects if consumed daily by a human over his or her lifetime. The proposed changes include revisions to existing MRLs, as well as new MRLs.

Because the MRLs apply both to foods produced domestically and foods imported into Canada, the World Trade Organization has also been notified so that consultation may also take place with non-domestic stakeholders. However, Health Canada does not anticipate that the proposed amendments would affect Canada's international trade activities because many of the proposed amendments are harmonized or comparable with those established by Canada's major trading partners, including the United States.

FDA Warning Letter update

2014-02-12T08:00:00.000-06:00

Author Lidia Niecko-Najjum*

Warning Letters issued to dairies

FDA issued Warning Letters to four dairies that sold adulterated animals for slaughter as food: Kissamee Farms in Cazenovia, NY; Three L Farm in Ellenburg Depot, NY; Balbian Farm in Amsterdam, NY; and the dairy farm of Jacob F. Stoltzfus in Lititz, PA.

Such food is deemed to be adulterated if 1) it bears or contains a new animal drug that is unsafe, and/or 2) the animal has been held under insanitary conditions. Failure to maintain complete treatment records presumes the food to be held under insanitary conditions.

The United States Department of Agriculture, Food Safety and Inspection Services (USDA/FSIS) examined tissue samples from the recipient dairies and found drug residue at each. These findings showed that the dairies exceeded FDA's acceptable drug residue levels and the four dairies failed to maintain complete animal treatment records.

It was further found that two of the dairies, Kissamee Farms and Balbian Farm, also used drugs off-label. The off-label use of approved animal or human drugs in animals is allowed under the FDCA only if a licensed veterinarian within the context of a valid veterinarian-client/patient relationship prescribes it. However, no record of supervision by a licensed veterinarian was found at either dairy.

Warning Letters issued to seafood processing facilities

FDA issued Warning Letters to two seafood processing facilities for selling adulterated products under the seafood Hazard Analysis and Critical Control Point ("HACCP") regulation: Quality Beef Company, Inc. in Providence, Rhode Island and Nobuo T. Hawaii Inc. in Honolulu, Hawaii.

Under the HACCP regulation, a seafood processing facility must have an annually signed and dated HACCP plan. The HACCP plan must contain the appropriate "critical limits" which are measured and verified. These would include, for example, temperature control measures that are monitored with calibrated instruments. Any importer of seafood also must have a written import verification procedure to ensure the imported fish and fishery products were processed in accordance with U.S. standards.

Seafood products at these two facilities were deemed adulterated because both failed to properly document, implement, and monitor their respective HACCP plans—particularly with regard to the "critical limits." Further, Quality Beef Company, Inc. lacked a written import verification procedure for its products imported from Canada. And, Nobuo T. Hawaii Inc. was awaiting a re-inspection to address its previously cited unsanitary conditions.

Warning Letters issued to juice processing facilities

The Buchanan Manufacturing Inc. d/b/a Grow Agra juice processing facility in Buchanan, TN received a Warning Letter for selling adulterated juice products.

Under the juice HACCP regulation, a HACCP plan must list all of the food hazards reasonably likely to occur. Food hazards include "any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control." The juice HACCP plan must include control measures "that will achieve a 5-log reduction of the pertinent microorganism within a single facility operating under current good manufacturing practices that include monitoring procedures and frequencies." Additionally, it must contain the appropriate, predetermined corrective action plans to activate at deviation from a critical limit.

The Warning Letter found that Grow Agra failed to include all of the food hazards, the necessary control measures, and the corrective action plans in its HACCP plan.

Companies in receipt of a Warning Letter have 15 days to respond to the agency, in writing, to explain the steps taken to correct the violations. The FDA then evaluates the responses and, if needed, can take regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures.

See the 2014 Warning Letters.

Maine becomes second state to require GMO labeling

2014-02-10T08:00:00.000-06:00

Author Erin Close*

Admitted only in the State of New York. Practice supervised by principals of the firm admitted in DC

In early January, Maine became the second state in the country to implement a law that requires labeling for foods produced with genetically modified organisms (GMOs). However, the requirement will go into effect only after four other contiguous states (at least one of which must border Maine) approve similar legislation. Maine's law follows Connecticut's GMO Labeling Bill, which was passed in June 2013 with a similar requirement that it not go into effect until four other states, one of which must share a border with Connecticut and whose populations total more than 20 million people, enact similar measures.

Maine's Act to "Protect Maine Food Consumers' Right to Know about Genetically Engineered Food and Seed Stock" requires a conspicuous disclosure reading "Produced with Genetic Engineering," to be located on the package or label of a product produced using genetic modification. The legislation also prohibits any produce that is labeled as such from also being labeled as "natural".

The disclosure is not required for food served in restaurants, alcoholic beverages, or medical foods. The bill also defines exceptions for foods made without the knowledge that genetically engineered ingredients were involved in the production, or if the distributor or retailer relied on sworn testimony from the producer stating that the food was not genetically modified. Additionally, the disclosure is not required for food derived from an animal that was not itself genetically engineered but was fed genetically engineered feed.

Maine's legislation states that the purpose of the law includes increasing public health and food safety; assisting consumers who are concerned about the environmental impacts of GMOs in making informed purchasing decisions; reducing consumer confusion regarding food labels; and creating market opportunities for food producers who are not certified organic producers but whose products are not produced using genetic engineering.

According to the National Conference of State Legislatures, approximately 30 states are considering similar legislation. Alaska passed a law requiring labeling for genetically modified foods in 2005, but that law applies only to genetically engineered fish and shellfish. Washington state voters rejected a similar initiative in a November ballot initiative, but state lawmakers are continuing the debate and have since introduced at least two bills requiring GMO labeling for specific types of foods.

The full text of Maine's new legislation can be found here.

FDA issues proposed rule to protect food against intentional adulteration

2014-02-06T08:00:00.000-06:00

Author Megan Fanale Engel

On December 24, 2013, the FDA issued a proposed rule entitled "Focused Mitigation Strategies to Protect Food against Intentional Adulteration." Passed under the Food Safety Modernization Act ("FSMA") in 2011, the FDA issued this rule to focus on food defense, which would require all domestic and foreign food facilities to address potential issues in their facilities' operations that would make the facilities susceptible to large-scale, intentional public harm. The proposed rule would apply to all domestic and foreign food facilities that process, manufacture, pack, or hold food and are required to register as a food facility, with a few exceptions.

In the rule, the FDA has identified four key areas within the food system that may be most susceptible to intentional harm: (1) liquid storage and handling activities; (2) bulk liquid receiving and loading; (3) activities involving how secondary ingredients (ingredients other than the primary ingredients) are handled before being combined with the primary ingredient; and (4) mixing activities. The proposed rule would require food facilities to review their food production systems to determine if there are any of the identified areas or to complete their own assessment for vulnerable activities. Once identified, the facility must then establish mitigation strategies that would reduce the risk of intentional adulteration and prepare a written food defense plan. The proposed rule would require food facilities to establish measures to protect against food terrorism.

The written food defense plan must include the following items:

Actionable process steps – food facilities must identify actionable process steps by looking for one of the four key areas set forth above or conduct their own vulnerability assessment;
Focused mitigation strategies – implement mitigation strategies at every point of vulnerability to minimize such vulnerability;
Monitoring – establish procedures for monitoring the focused mitigation strategies at certain intervals;
Corrective actions – use corrective actions to address any focused mitigation strategies that are not properly implemented;
Verification – ensure that monitoring is being conducted or corrective actions are taken at appropriate intervals;
Training – train personnel assigned to the actionable process steps in food defense awareness; and
Recordkeeping – maintain certain records, including the written food defense plan and documentation of monitoring, verification, corrective action, and training of personnel.

The FDA has proposed that compliance with the rule will generally be required starting 60 days after the date of the final rule. However, the FDA has adjusted the compliance dates for small or very small businesses.

The public comment period will remain open until March 31, 2014. Review the proposed rule.

Department of Health and Human Services releases 2014 regulatory agenda

2014-02-04T08:00:00.000-06:00

Author Lidia Niecko-Najjum*

*Admitted to practice in Virginia; practice directly supervised by principals of the firm admitted in the District of Columbia.

The Department of Health and Human Services ("HHS") released its Semiannual Regulatory Agenda on January 7, 2014, as required by the Regulatory Flexibility Act of 1980 and Executive Order 12866. The FDA is the HHS agency charged with promulgating regulations related to food safety, including the provision of accurate, science-based information to the public. The food-related regulations as numbered on the Agenda are listed and briefly described below under three categories: (1) proposed rule stage, 2) final rule stage and 3) completed actions. HHS and the FDA welcome comments on any of its Agenda items, which you can read more about here.

Food-Related Priorities on the Semiannual Regulatory Agenda:

PROPOSED RULE STAGE

276. Food Labeling; Revision of the Nutrition and Supplement Facts Labels

FDA is proposing to modernize the Nutrition Facts label, including updated nutrition information and the format and appearance of the label for easier consumer use.

277. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual Column Labeling; Updating, Modifying, and Establishing Certain RACCS

FDA is proposing to provide consumers with nutrition information for certain food categories based on the amount of food that is customarily consumed, referred to as Reference Amounts Customarily Consumed (RACCs). In addition to updating certain RACCs, FDA is also considering the provision of dual-column labeling to indicate nutrition information per serving and per container for certain containers.

280. Updated Standards for Labeling of Pet Food

FDA is proposing to provide pet owner and animal health professionals more complete information about the nutrient content and ingredient composition of pet food products.

281. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

FDA is proposing to provide preventive controls for animal food, including the ingredients and mixed animal feed, to ensure safety for all animals.

284. Produce Safety Regulation

FDA is proposing to establish science-based minimum standards for the safe production and harvesting of raw agricultural commodities to reduce the risk of illness associated with fresh produce. The Secretary has determined the types of fruits and vegetables for which such standards minimize the risk of serious adverse health consequences or death.

285. Hazard Analysis and Risk-Based Preventive Controls

FDA is proposing to implement preventive controls at food facilities to avoid or, at a minimum, quickly identify foodborne pathogens before they get into the food supply.

288. Foreign Supplier Verification Program

FDA is proposing regulations to improve the safety of food imported into the United States by imposing requirements on foreign suppliers to verify that the imported food is produced according to US standards.

FINAL RULE STAGE

298. Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines

FDA is issuing a final rule to 1) establish requirements for nutrition labeling of certain food items sold in certain vending machines, and 2) establish terms and conditions for vending machine operators registering to voluntarily be subject to the requirements. FDA is taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act ("ACA").

299. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

FDA is issuing a final rule to 1) establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail food establishments, and 2) establish terms and conditions for restaurants and similar retail food establishments registering to voluntarily be subject to the Federal requirements. FDA is taking this action to carry out section 4205 of the ACA.

300. Use of Certain Symbols in Labeling

FDA is issuing a final rule to allow for the inclusion of certain stand-alone symbols in medical devices, provided that such symbols are explained in a symbols glossary that contemporaneously accompanies the medical device.

COMPLETED ACTIONS

307. Food Labeling: Serving Sizes; Reference Amount and Serving Size Declaration for Hard Candies and Breath Mints

FDA is proposing to change the nutrition label serving size for breath mints to one unit. This is a response to a citizen petition that requested a serving size for breath mints that more accurately reflects the amount customarily consumed per eating occasion and the comments received on an advance notice of proposed rulemaking published in 2005.

308. Food Labeling; Gluten-Free Labeling of Foods

FDA is amending its regulations to define the term "gluten-free" for voluntary use in food labeling, to provide easier identification of foods appropriate for a "gluten-free" diet.

Read more on the Federal Register site.

FDA stays out of natural fight

2014-01-29T08:00:00.000-06:00

Author Brandon Lee Crisp

Earlier this month, the US Food and Drug Administration ("FDA") sent a letter to three federal judges refusing to determine whether foods with genetically modified ingredients can be labeled as "natural." The letter was in response to three federal court orders staying and administratively terminating class actions involving food labeled as "natural."

The FDA's assistant commissioner for policy, Leslie Kux, stated in the letter that the agency would decline to determine "whether and under what circumstances food products containing ingredients produced using genetically engineered ingredients may or may not be labeled 'natural.'" Kux described the complexities of making such a determination, which included the involvement of other federal agencies such as the United States Department of Agriculture ("USDA"). She indicated that the two agencies have discussed a potential definition and are currently considering the issue.

Kux also recognized the "competing concerns among and between stakeholders . . . ." The FDA didn't rule out eventually creating a formal definition but stated that it would probably "engage the public on this issue," presumably by issuing a regulation or formal guidance for public comment.

In addition to the concerns and complexities of making such a determination, Kux also noted that FDA's limited resources were focused primarily on developing regulations to implement the Food Safety Modernization Act, issuing nutrition labeling regulations, and "other actions with direct public health impact . . . ."

Without a definition from FDA, food companies will probably see an uptick in class actions because the FDA's letter will make it harder for defendants to win with preemption and primary jurisdiction defenses. Defendants, however, will still have other avenues of attack. Some food-company defendants have successfully defended such claims by arguing a reasonable consumer would not be misled by the "natural" label. See e.g. Pelayo v. Nestle USA, Inc., 2013 WL 5764644 (C.D. Cal. Oct. 25, 2013) (dismissing such a claim against Nestle USA, Inc.). But for the foreseeable future, it appears that consumers and food companies will be left to continue guessing—and litigating—whether and how "all natural" should be defined.

Supreme Court accepts Pom Wonderful v. Coca-Cola case

2014-01-27T08:00:00.000-06:00

Author Katharine Taylor Larson

The United States Supreme Court granted certiorari on January 10, 2014, in Pom Wonderful LLC v. The Coca-Cola Company. The Court must now decide whether the Food, Drug, and Cosmetic Act ("FDCA") bars Lanham Act claims for deceptive naming and labeling of food products.

Pom Wonderful brought suit against Coca-Cola under the Lanham Act in 2008, contesting the legitimacy of the name, labeling, marketing, and advertising of a Minute Maid juice owned by Coca-Cola. The complaint accused Coca-Cola of deceptive practices concerning a juice consisting almost entirely of apple and grape juices that was sold as a "Pomegranate Blueberry Flavored Blend of 5 Juices." In May 2012, the 9th Circuit Court of Appeals affirmed summary judgment in favor of Coca-Cola, holding Pom Wonderful's deceptive name and label claims were barred by the FDCA.1 Pom Wonderful LLC v. The Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012). The Circuit declared "that the Lanham Act may not be used as a vehicle to usurp, preempt, or undermine FDA authority."

Coca-Cola and Pom Wonderful dispute the significance of the Ninth Circuit's decision. In their petition for certiorari, Pom Wonderful claimed that "[u]nder the Ninth Circuit's ruling, so long as products meet the FDA's minimum requirements, manufacturers can label them in any manner, without regard to whether their labeling deceives consumers." Coca-Cola responded that contrary to Pom Wonderful's assessment, the FDA employs a stringent and comprehensive regulatory framework that effectively protects consumers and supervises food labeling and naming.

Interestingly, the US Solicitor General requested that the Supreme Court decline to hear the case while simultaneously claiming that the Ninth Circuit's decision over-expanded the preclusive effect of the FDCA. The amicus curiae brief for the United States argued that although the Ninth Circuit's decision was questionable, the lack of a circuit conflict and ambiguous factual allegations in the record rendered the appeal unworthy of the Supreme Court's attention.

Justices Alito and Breyer did not participate in the consideration of the petition for writ of certiorari. Therefore, it is possible that only the remaining seven Justices will decide the case. Oral argument is expected to occur in April and an opinion will likely be issued in June.

The FDA's 2013 Annual Report on food facilities, food imports, and FDA foreign offices

2014-01-24T08:00:00.000-06:00

Author Katharine Larson

Pursuant to Section 201(b) of the 2011 Food Safety Modernization Act (FSMA), the Secretary of Health and Human Services is required to provide Congress with an annual account of the Food and Drug Administration's (FDA) collaborative efforts with other agencies and with data on food facilities, food imports, and the FDA's foreign offices. In November, the FDA submitted to Congress its 2013 annual report.

A majority of the report detailed the various programs being undertaken by the FDA in conjunction with other federal, state, or local agencies. These joint efforts include developing a national laboratory proficiency-testing platform and creating multi-jurisdictional Rapid Response Teams. The FDA further disclosed participation in a multi-agency council dedicated to identifying indicators of economically-motivated adulteration of food products.

The report also provided information on the inspection of food facilities based on the 2012 fiscal year. Importantly, the data collected and submitted to Congress in the FDA's report attempted to utilize the high-risk versus non-high-risk classification system created by the FSMA. Among other things, the FSMA requires the FDA to identify the number of high-risk facilities that were supposed to be inspected, the number of high-risk facilities inspected, and the number of high-risk facilities that were not inspected. Based on the old system, in 2012, the FDA inspected or attempted to inspect 24,462 domestic and 1,342 foreign food facilities. Approximately 11,759 of these inspections were of facilities now classified as high-risk. However, the report indicated that because the high-risk versus non-high-risk classification system is new and not yet completely implemented, much of the data for these categories is unavailable. The report repeatedly states that the "FDA is attempting to inspect all initially-identified high-risk facilities in three years (FY 2011-2013), 2 years earlier than directed by [the FSMA]."

The report also included a section on food imports. The FDA physically examined 207,839 of 11,136,599 food import lines in the 2012 fiscal year, or approximately 1.9 percent. However, all food import lines were electronically screened in an effort to aid field inspectors in determining which lines required physical inspection. The FDA recently increased the efficacy of their screening process by using "data analytics from the entire life cycle of a product" in order to identify those needing inspection. Additionally, products subject to refusal based on "existing evidence" may be preemptively stopped at the border until the importer is able to prove compliance.

The FDA further reported that it has 12 foreign offices.

FDA Warning Letters –year in review

2014-01-21T08:00:00.000-06:00

Author Erin Close*

The US Food and Drug Administration ("FDA") issued over 600 Warning Letters in 2013. About 230 of those Warning Letters, more than 35 percent, were related to food. Below is an overview of this year's Warning Letters.

Almost half 8 of the 230 food-safety-related Warning Letters issued over the last year addressed violations of the Current Good Manufacturing Practices (CGMP) in Manufacturing, Packing, or Holding Human Food. Food produced in a facility that is in violation of the CGMP is considered adulterated in that the food has been manufactured, prepared, packed, or held under such conditions that it is rendered unfit for food and/or injurious to health.

Almost 40 percent of this year's letters addressed illegal drug residue. Typically addressed to dairies, such letters are issued when an illegal amount of drug residue is found in the tissue of an animal sold for slaughter. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. While the legal amount for drug presence varies (from zero to a specified percentage point), dairies are expected to hold their animals under conditions that are adequately monitored, and maintain treatment records so that animals bearing potentially harmful drug residues do not enter the food supply.

Almost one third of letters in 2013 alleged violations of the Seafood Hazard Analysis and Critical Control Points (HACCP) regulation, codified at 21 CFR Part 123. The Seafood HACCP is a preventive system of hazard control that can be used by processors to ensure the safety of their products to consumers. The Seafood HACCP requires that all Seafood production and importer facilities have in place a HACCP plan that identifies the hazards that are reasonably likely to occur during the production of each firm's products, and thus must be controlled for during production. The FDA Warning Letters that address the Seafood HACCP typically address weaknesses or failings within a firm's HACCP plan, or a firm's failure to follow its established HACCP. Multiple letters were also issued for violations of the juice HACCP regulation, codified at 21 C.F.R. Part 120.

The agency has shown no signs of an intent to slow its issuance of food-related Warning Letters. Food manufacturers and facilities should expect continued scrutiny in the coming year. All Warning Letters issued during 2013 can be found here.

*Admitted only in the State of New York. Practice supervised by principals of the firm admitted in DC
8 Please note that a majority of the letters allege multiple types of regulatory violations

FDA Warning Letter update

2014-01-16T08:00:00.000-06:00

Author Erin Close*

It is FDA's practice to issue Warning Letters in order to provide individuals and companies an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. The agency's position is that it issues Warning Letters only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act ("the FD&C Act"). Below is a brief synopsis of recent food-related Warning Letters.

Warning Letters issued to dairies

The FDA issued Warning Letters to ten dairies for selling animals for slaughter that were adulterated. The New York District Office issued six of these warnings. Under 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under unsanitary conditions whereby it may have been rendered injurious to health. The recipient dairies were found to have introduced animals with unsafe levels of various drugs, including desfuroylceftiofur, flunixin, and sulfamethoxazole present in the animal's tissue into the food supply.

Each dairy was also found to generally hold its animals under conditions that were inadequately monitored. Specifically, all warned dairies were found to have failed to maintain treatment records for their cows. The FDA asserted that this inadequate monitoring caused it to be more likely that medicated animals bearing potentially harmful drug residues would enter the food supply.

Finally, all dairies to which warning letters were issued were found to have used pharmaceuticals in their cows in a manner not allowed by regulations. The extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. Most of the dairies were found to have administered drugs to cows without the supervision of a veterinarian.

Warning Letters issued to food-processing facilities

Three food-processing facilities were found by FDA inspectors to have violated the Current Good Manufacturing Procedures (CGMP) for Human Food, Title 21, Code of Federal Regulations, Part 110. The products, which included cheese, read-to-eat sandwiches, and almond butter, among other products, were deemed adulterated under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] in that they have been "prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health." Violations include the failure of employees to properly wash their hands or change protective gloves between tasks, failing to sanitize production surfaces, and utilizing cardboard "with heavy filth buildup" in the food production process.

Warning Letters issued to seafood processing facilities

Four seafood processing facilities were issued Warning Letters for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, codified in 21 CFR § 123: Because these facilities failed to properly implement their HACCP plans, their seafood products were rendered adulterated within the meaning of Section 402(a)(4) of the FD&C Act, 21 USC. § 342(a)(4). The facilities' HACCP plans lacked required procedures, or, for certain products, did not exist at all. Additionally, the facilities failed to properly follow certain procedures listed in their HACCP plan.

Warning Letters issued to processor of acidified foods

The FDA issued a Warning Letter to a manufacturer of acidified foods due to its failure to schedule processes with FDA for foods produced, as required by the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR 114). For those processes that the FDA did have on file, the firm failed to follow them in its production of its hot sauce, in addition to other products. Due to these violations, the agency found that the food and acidified food products were adulterated within the meaning of section 402(a) of the Act (21 U.S.C. 342(a)(4)). Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available here.

Companies in receipt of a Warning Letter have 15 days to respond to the agency in writing to explain the steps taken to correct the violations. FDA evaluates the responses and, if needed, can take regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures.

*Admitted only in the State of New York. Practice supervised by principals of the firm admitted in DC

Expansion of FoodNet Canada

2014-01-13T08:00:00.000-06:00

Author Martha A. Healey

In an announcement relating to additional food safety measures, in November 2013, Canada's Minister of Health announced the expansion of FoodNet Canada 7. FoodNet Canada is made up of three surveillance sites located across the country. In addition to the new site in Alberta, there is a site in the Region of Waterloo, Ontario and the Fraser Region in British Columbia. The sites will each collect detailed information about food-borne illness and trace those illnesses back to their sources, such as food, water, and animals. The information collected is expected to identify illness sources and help track illnesses and causes of those illnesses over time to assist federal and provincial governments, industry, and other food safety partners to take preventative measures.

7 Health Canada, "Harper Government announces enhancements to maintain healthy and safe food for Canadians", November 15, 2013, online at: http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-164-eng.php