By Riëtte van Laack –
On May 9, 2013, the U.S. Court of Appeals for the Third Circuit affirmed a District Court’s decision that a state law class action concerning claims regarding the absence of trans fat and cholesterol lowering effect was preempted.
The case, Young v. Johnson & Johnson (“J&J”), involved J&J’s Benecol Spreads. Plaintiff asserted various state law causes of action based on allegedly false and misleading labeling of Benecol. Specifically, plaintiff alleged that the claim that the product contained no trans fat was misleading because, although the amount of trans fat per serving was sufficiently low to require declaration as zero g per serving in the Nutrition Facts box, the products do contain a small amount trans fat. In addition, plaintiff alleged that the claim that Benecol spreads reduced cholesterol was false and misleading because the claim did not specify that the cholesterol reduction was due to the presence of plant stanol esters in the Benecol spreads, and the presence of trans fat in the spreads invalidated the claim.
Defendant argued that the claims were expressly preempted by the FDC Act § 403A(a) barring state nutritional labeling requirements that are not identical to the FDC Act and FDA’s implementing regulations.
The Court interpreted the preemption provision broadly. It held that although the FDA regulations did not expressly permit the claim “No Trans Fat,” the regulations do allow claims about the amount of a nutrient if it is not false and misleading. The Court reasoned that the claim “No Trans Fat” was not misleading because an amount of less than 0.5 g trans fat per serving must be identified as 0 g in the Nutrition Facts box, and because the regulations specifically allow a “no [nutrient]” claim for other nutrients (such as fat) if the product contains less than 0.5 g of the nutrient. The Court concluded that plaintiff was attempting to enforce a state law requirement that was not identical to the federal requirement.
Similarly, according to the Court, the cholesterol reduction claim for Benecol spreads appeared to comply with the applicable FDA regulations. In fact, the regulations specifically authorize a cholesterol reduction claim for foods containing stanols, and an insignificant amount of trans fat does not disqualify a product for the claim. Thus, plaintiff sought to impose a standard that is not identical to the standard set forth in FDA regulations and therefore plaintiff’s claim was expressly preempted.
By Ricardo Carvajal & Wes Siegner -
A year ago, FDA issued a warning letter to USPlabs alleging that certain products containing dimethylamylamine ("DMAA") that were marketed as dietary supplements were adulterated because (1) DMAA is a new dietary ingredient ("NDI") for which no notification had been submitted as required under FDCA section 413, and (2) the products contain an NDI for which there is inadequate information to provide reasonable assurance that the NDI does not present a significant or unreasonable risk of illness or injury. FDA further contended that synthetically produced DMAA does not qualify as a dietary ingredient.
USPlabs disagreed with FDA’s allegations, and FDA has now posted a follow-up letter in which FDA elaborates on its position. In that letter, FDA disagrees that DMAA qualifies as a dietary ingredient by virtue of being a constituent of a botanical, namely the geranium P. graveolens. FDA also disagrees that DMAA is a dietary substance, absent evidence of its presence in geraniums or evidence of common use as a food or drink. FDA therefore concludes that DMAA is an unsafe food additive that renders the products in question adulterated. However, perhaps of greatest interest is FDA’s application of 301(ll)’s prohibition against the introduction into interstate commerce of any food to which an approved drug has been added. FDA states:
DMAA was approved as a drug in 1948… and… was not marketed in food prior to such approval, either on its own or based on its alleged presence as a component of P. graveolens. You have not presented any evidence of such marketing. In the absence of such evidence, your. . .products are in violation of section 301(ll) of the Act.
Thus, FDA appears to conclude without explanation that section 301(ll) applies to prohibit the introduction or delivery for introduction into interstate commerce of the products in question because they are “food” to which an approved drug (DMAA) has been added. This implies one of two additional conclusions: (1) the products are not dietary supplements, but are instead conventional foods to which 301(ll) applies, or (2) the products are dietary supplements, but 301(ll) nonetheless applies. The basis for either of these conclusions is not readily apparent. Arguably, the second conclusion would be a more interesting regulatory development than the first, as we are not aware of any prior instance in which FDA has applied section 301(ll) to prohibit the marketing of a dietary supplement.
One of the more significant questions raised by the addition of section 301(ll) to the FDCA is whether that section applies to dietary supplements, given the fact that the language of the provision does not explicitly mention dietary supplements, and that there already exists a similar provision that explicitly applies to dietary supplements – namely section 201(ff)(3)(B). In fact, FDA raised this very question in its request for comment on the implementation of section 301(ll) (see our prior post here). Unfortunately, the cursory reference to section 301(ll) in FDA’s follow-up letter to USPlabs raises more questions than it answers.
Earlier this week, the National Organization for Rare Disorders (“NORD”) held its annual gala here in Washington, D.C. recognizing achievements and advances in the area of rare (orphan) diseases. Of course, this year is extra special; it’s the 30th anniversary of the enactment of the Orphan Drug Act (see our previous anniversary post here) and the 30th anniversary of the founding of NORD.
With 30 years having gone by, you can imagine that NORD had a long list of folks to thank for what some have called the most successful piece of food and drug legislation ever enacted. Leadership in public policy awards were handed out to Deputy Secretary of the Department of Health and Human Services William V. Corr, Senator Nancy Kassebaum (KS-Retired), and Representative Henry Waxman (CA). Awards for vision and pioneering guidance were given to NIH Office of Rare Diseases Research Director Stephen C. Groft, former FDA Office of Orphan Products Development Director Marlene E. Haffner, Swedish Orphan International AB founder Lars-Uno Larsson, NORD founder Abbey S. Meyers, and Jess G. Thoene, who served as Chairman of the NORD Board of Directors and edited two editions of the Physician’s Guide to Rare Diseases. Then NORD announced the recipient of the award for lifetime achievement . . . . Hyman, Phelps & McNamara, P.C. Director Frank J. Sasinowski.
Frank played a major role in implementing the Orphan Drug Act during his tenure at FDA between 1983 and 1987, and was instrumental in two amendments to the law – in 1984 and 1985 – that strengthened the Orphan Drug Act. Since 2000, Frank has served on the NORD Board of Directors, first as vice chair and later as chair. More recently, Frank served as the principal analyst and author of a seminal report, titled “Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs,” on the ways in which FDA has exercised flexibility in the review and approval of non-oncologic orphan drug products (see our previous post here). Congratulations Frank (“Mr. Orphan Drug”)!
In the Federal Register of May 8, 2013, FDA announced a public meeting titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.” The notice states that the focus of the meeting will be “FDA's interpretation of its regulations concerning when a modification made to a 510(k)-cleared device requires a new 510(k) submission.” The meeting is to be held on June 13, 2013, from 9am to 5pm. The registration deadline is May 30, 2013.
As discussed in our previous blog post, in July 2011 FDA issued a guidance document intended to update the 1997 guidance of the same name as the meeting. The guidance was met with strong resistance from industry, insisting that the interpretations applied in the guidance would result in the requirement to submit a new 510(k) for numerous device modifications. In response to the feedback from industry, Congress, in enacting the Food and Drug Administration Safety and Innovation Act ("FDASIA") in July 2012, required FDA to withdraw the guidance and prohibited FDA from implementing a new guidance until it submits a report to Congress describing when a new 510(k) should submitted. The report must include FDA’s interpretation of several key phrases in 21 C.F.R. 807.81(a)(3), the regulation governing submission of a new 510(k) for a modification to an existing product. In addition, the report must include “possible processes for industry to use to determine whether a new 510(k) is required, and how to leverage existing quality system requirements to reduce premarket burden, facilitate continual device improvement, and provide reasonable assurance of safety and effectiveness of modified devices.” The public meeting is intended to solicit stakeholder feedback on these issues. On a related note, FDA recently issued a draft guidance on when modifications must be reported to FDA, which also received substantial negative feedback from industry (see our previous post here). Perhaps issues discussed at the 510(k) meeting will shed light on those concerns as well.
In the notice, FDA provides a number of specific policy options on which it is seeking feedback, but notes that “implementation of some of these options may require regulatory changes beyond a guidance document.” These options appear to be new ideas that have not previously been presented by FDA, and ones that industry would likely agree require changes beyond a guidance document. In some cases, the changes may require statutory, rather than merely regulatory, changes.
The notice sets forth five policy options, and also asks for ideas of additional policy proposals and examples of device changes that industry believes should not trigger the requirement for a new 510(k). Under each of the five policy options, FDA poses questions on which it is seeking comment prior to the public meeting and will be discussed at the meeting.
The five policy options and examples of the questions for feedback include:
A. Risk Management
FDA says it is primarily concerned with identifying a way to incorporate risk management to ensure “appropriate and consistent modification decisions by industry and FDA staff.” Such decisions are those “that allow for both medical device innovation and effective FDA oversight of device changes.” FDA recognizes the importance of ensuring a process to ensure consistent results, since decisions will be made by a variety of different manufacturers and FDA reviewers. To address these concerns, FDA seeks input on the following:
B. Reliance on Design Control Activities
The notice expresses FDA’s desire for effective oversight of the design control process, including the opportunity to review design control activities. FDA states that “improper application of these activities may lead to incomplete or inaccurate evaluations of design changes and the marketing of unsafe or ineffective devices.” In considering how FDA can affect oversight of design controls, FDA seeks input on the following:
C. Critical Specifications
FDA states in the notice that critical specifications could be one way that FDA could link use of design activities to 510(k) modification decisions. This would involve industry and FDA identifying “essential” or “critical” specifications and agreeing on limits and testing protocols for those specifications. So long as the modified device remains within those limits, no new 510(k) would be required. FDA indicates that it would like to discuss the feasibility of this approach with industry, and how it might be implemented. It also states that this approach would not apply to changes to intended use or labeling, “as those aspects of a device are not associated with specifications.”
Based on information provided in the notice, it appears that this approach may be quite burdensome for manufacturers and reviewers. FDA states that, in an initial 510(k) submission, manufacturers would have to identify the following information: a list of potential changes that might be made; critical specifications for each change, i.e., those specifications “that are essential to safe and effective use of the device (e.g., tensile strength)”; bounds for those specifications within which a modified device must remain; and the verification and validation test protocols that will be used to examine the specifications pre- and post-modification. Providing this information would require a significant amount of work by sponsors, and raise new issues for FDA reviewers.
Given the above, FDA is seeking input on the following questions:
D. Risk-Based Stratification of Medical devices for 510(k) Modifications Purposes
Under this framework, FDA would expect 510(k)s for modifications of higher risk devices that meet the standard in 21 C.F.R. § 807.81(a)(3), whereas for lower risk devices, not all modifications would require a 510(k) even if they meet the regulatory standard. Certain modifications, such as a change in intended use, would always require a 510(k), regardless of the level of risk of the device. FDA has the following questions about this approach:
E. Periodic Reporting
FDA is seeking feedback on the submission of periodic reports for modifications to 510(k)-cleared devices that did not require a new 510(k) submission. FDA acknowledges that this would “be similar to annual reporting of device changes for approved class III devices.” It also states that FDA would review these changes to “ensure that decisions were made appropriately.”
FDA would like feedback regarding:
This seems like an option that probably would not appeal to industry as crafted, as it would be imposing an additional obligation not currently required by the regulations. Moreover, it would almost certainly lead to second-guessing “no-file” decisions. If FDA and industry can work to clearly delineate when a new 510(k) is required for a modified device, there should be no need for FDA to review information about modifications that do not fit that paradigm.
Given the negative industry response to the July 2011 draft guidance, industry should take advantage of this opportunity to work with FDA to design a modifications paradigm that will meet the regulatory requirements without imposing burdens unnecessary to assure the development and marketing of safe and effective medical devices and enable further product improvements.
The issue of 510(k) modifications is both recurring and important. This public meeting will not be the final word. Still, it provides an important forum for responding to some novel ideas that have been broached by FDA.
On May 4, 2013, Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro presented a draft paper and slides on the 510(k) medical device substantial equivalence program during a conference on FDA in the 21st Century. The conference was held at the Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (see our previous post here). The draft paper argues that the 510(k) program is an excellent approach to the premarket review of medium risk medical devices, and has strengths that critics have overlooked.
The draft paper can be found here. The slides presented on May 4 are available here.
By Kurt R. Karst –
Late last Friday, FDA announced that the Agency denied an August 13, 2012 Citizen Petition (Docket No. FDA-2012-P-0895) submitted by Endo Pharmaceuticals Inc. (“Endo”) requesting that the Agency determine that OPANA ER (oxymorphone HCl) Extended-release Tablets approved under NDA No. 021610 were discontinued for safety reasons in light of the availability of a reformulated version of OPANA ER approved under NDA No. 201655, and that FDA refuse to approve any pending ANDAs and suspend and withdraw the approval of any ANDAs citing original OPANA ER as its Reference Listed Drug. The decision, which is apparently the first under the new 270-day timeframe at FDC Act § 505(w) covering discontinuation petitions submitted pursuant to 21 C.F.R. § 314.161, comes less than a month after FDA determined that OXYCONTIN (oxycodone HCl) Controlled-release Tablets approved under NDA No. 020553 were discontinued for safety reasons in light of the availability of a reformulated version of OXYCONTIN approved under NDA No. 022272 (see our previous post here). On the same day FDA announced its decision concerning reformulated OXYCONTIN, the Agency approved abuse-deterrent labeling for the drug. A decision on abuse-deterrent labeling for reformulated OPANA ER did not surface last week, perhaps presaging FDA’s petition decision.
Endo argued in its petition that the reformulated version of OPANA ER approved under NDA No. 201655 (referred to as “OPR”) offers safety advantages over original OPANA ER (referred to as “OP”) because, among other things, the reformulated version “is resistant to crushing by common methods and tools employed by abusers of prescription opioids . . . [and] is less likely to be chewed or crushed even in situations where there is no intent for abuse, such as where patients inadvertently chew the tablets, or where caregivers attempt to crush the tablets for easier administration with food or by gastric tubes, or where children accidentally gain access to the tablets.” According to FDA, however, “[w]hile there is an increased ability of OPR to resist crushing relative to OP, data from in vitro and pharmacokinetic studies show that OPR’s extended-release features can be compromised, causing the product to ‘dose dump,’ when subjected to other forms of manipulation such as cutting, grinding, or chewing, followed by swallowing.” Moreover, commented FDA, it “appears that OPR can be prepared for insufflation (snorting) using commonly available tools and methods, [and] certain data suggest that OPR can more easily be prepared for injection than OP.” In addition, the data from the postmarketing investigations Endo relies to support the advantages of OPR over OP “are inconclusive,” determined FDA.
Citing drug product and data differences in the cases of OPANA ER and OXYCONTIN, FDA says that it is reasonable for the Agency draw different conclusions:
Based on in vitro, pharmacokinetic, clinical abuse potential, and post-marketing data, we were able to conclude that [original OXYCONTIN] posed an increased potential for intranasal abuse compared to [reformulated OXYCONTIN]. . . . While the available data show that there is an increased ability of OPR to resist crushing relative to OP, OPR still can be prepared for insufflation (snorting) using commonly available tools and methods. . . . . [T]he preliminary data from the Opana ER post-marketing investigations have significant limitations and are not as mature as the OxyContin postmarketing investigations . . . .
Perhaps the most important takeaway from FDA’ petition decision is this message: “Our decisions take into account the totality of the evidence for the particular drug at issue, and must be made on a case-by-case basis.” The OPANA ER and OXYCONTIN decisions can thus perhaps be viewed as bookends (or at least two opposing points on a continuum) for how FDA will address similar issues in the future. And it seems highly likely that the issue will arise again. It may arise when a non-abuse-deterrent version of a drug is replaced with a reformulated version alleged to be abuse-deterrent, or perhaps where an abuse-deterrent version of a drug is replaced with a new and improved abuse-deterrent version.
By Katie Bond –
A recent Freedom of Information Act (“FOIA”) decision from the U.S. Court of Appeals for the Fourth Circuit sends a strong message to federal agencies that the statutory time limits for FOIA responses must be honored.
On February 29, 2008, John J. Coleman filed a FOIA request with the Drug Enforcement Administration (DEA) seeking documents related to the scheduling of a drug, carisoprodol, under the Controlled Substances Act. Dr. Coleman offered to reimburse appropriate costs up to $1,000. Under FOIA, the DEA had 20 working days to respond unless it notified Dr. Coleman that “exceptional circumstances” warranted an extension. The DEA did not provide a notice of exceptional circumstances and did not respond at all until “one year, four months, and ten days after receiving Dr. Coleman’s request.” At that time, the DEA denied the request, on the grounds that $1,000 would not cover estimated fees of $1,780.75. Dr. Coleman appealed the fee assessment to the Department of Justice’s Office of Information Policy (“OIP”). He contended that fees should not apply given the DEA’s “excessive delay” and given that he was eligible for a fee waiver as a noncommercial requester. The OIP took “seven months and eleven days” to respond. The OIP apprised Dr. Coleman that it had remanded his request to the DEA for “reprocessing, including further consideration of [the appropriate] fee category.” After hearing no response for another four months, Dr. Coleman filed suit pro se in federal district court. The DEA moved for summary judgment arguing that Dr. Coleman had failed to exhaust administrative remedies and failed to pay the necessary fees for processing his request. The district court granted the DEA’s summary judgment motion. Dr. Coleman appealed to the Fourth Circuit. The Fourth Circuit, in Coleman v. DEA, reversed and remanded, finding in no uncertain terms that the DEA and OIP had demonstrated an “utter lack of due diligence” and that Dr. Coleman had faced “extended and inexcusable agency delay.”
The Fourth Circuit opinion, in effect, closes two potential loopholes in the FOIA time limits. First, the court rejected an argument by the DEA that it and the OIP had responded to Dr. Coleman prior to his lawsuit, and that even if the responses were not timely, the responses barred suit. The court reasoned that despite the DEA’s and OIP’s responses, to date, the continuing remand amounted to a continuing non-response and that “[a]lthough FOIA does not explicitly contemplate remands following administrative appeals, it is inconceivable that Congress intended to allow agencies to escape FOIA’s time limits by sitting on remanded requests indefinitely.” Second, the court rejected DEA arguments that Dr. Coleman had not exhausted administrative appeals for his fee waiver request. The court reasoned that “[t]he DEA would create a rule under which a FOIA requester must make distinct arguments addressing every individual component of an adverse fee determination before obtaining judicial review of that determination.” It observed further that “holding an ordinary citizen . . . to such an exacting standard would impose a burden not authorized by FOIA and would frustrate the statute’s purpose of ‘assur[ing] the availability of Government information necessary to an informed electorate.’”
It is worth noting that the OPEN Government Act of 2007 was not in effect at the time of Dr. Coleman’s FOIA request. It now provides federal agencies another means of extending the 20 day response period, besides “exceptional circumstances.” Under the “new” exception, if a federal agency finds that it needs additional information in order to respond to a request, it may contact the requester and, thereby, toll the 20 day period until it receives a reply. Even with the new exception, Coleman nevertheless portends that agency delays outside of the ambits of the law will not be tolerated.
By Riëtte van Laack –
Senator Barbara Boxer (D-Calif.) and Representative Peter DeFazio (D-Ore.) recently introduced the Genetically Engineered Food Right-to-Know Act (S. 809 and H.R. 1699) that would direct FDA to require labeling to identify genetically engineered (“GE”) foods “so that consumers can make informed choices about what they eat” (see here).
The bill would require labeling of virtually all GE whole and processed food (including dietary supplements). Exceptions include medical foods, foods served in restaurants and other similar eating establishments, and foods containing GE processing aids, such as yeast. The proposed bill includes a provision that allows manufacturers to rely on guarantees by their suppliers that the food ingredients supplied are not GE, thereby reducing the testing burden on manufacturers.
Under FDC Act sections 403(a)(1) and 201(n), a food is misbranded if its labeling is false or misleading in any particular, including by failing to disclose facts material with respect to the consequences which may result from use of the food under customary or usual conditions of use. Since 1992, however, FDA has taken the position that bioengineered foods (FDA prefers the term bioengineered to GE) as a class are not materially different from conventional foods, and therefore there is no basis to require labeling that specifies their method of production.
However, consumers (or at least consumer activists) appear to disagree. In 2011, several consumer advocacy organizations petitioned FDA to develop regulations requiring labeling of GE foods, arguing that there is a material difference between GE and non-GE foods (see our previous post here). In addition, legislation that would require labeling of GE foods has been introduced in a number of states. Thus far, these efforts have met with limited success. Recently, some retailers have stepped in. A couple of months ago, Whole Foods announced that it will require that any GE foods sold in its stores must be labeled as such by 2018.
Which effort will succeed remains to be seen. However, it appears that GE labeling of foods is could well become a reality, be it through legislation or other means.
By Kurt R. Karst –
Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Doctor Who, Star Wars, and, of course, Star Trek. I remember well the voyages of the starship Enterprise under the command of Captain James T. Kirk (in rerun). I also remember the September 1987 premier of Star Trek: The Next Generation, when command of the Enterprise changed to Captain Jean-Luc Picard. Like many Star Trek fans, I grew to like the style of Captain Picard, while still appreciating the standard set and foundation laid by Captain Kirk. Life, like television series and the movies, is full of transitions – a “handing off of the baton.” The Food and Drug Bar is no different.
As I think back on my development as a member of the Food and Drug Bar, and, in particular, on my development as an attorney who specializes on drug matters, particularly with regard to the Hatch-Waxman Amendments, two memories immediately come to mind. The first memory is as a budding attorney while working for Hoffmann-La Roche in Washington, D.C. in the late 1990s. George Johnston, Vice President and Chief Patent Counsel at Hoffmann-La Roche, introduced me to the Hatch-Waxman Amendments. The complexity of the statute immediately grabbed my interest. My second memory is of being led to the library at Hyman, Phelps & McNamara, P.C. by former FDA Chief Counsel Tom Scarlett not too long after I joined the firm. I asked Tom what publications I should read to gain an expertise in the Hatch-Waxman Amendments. Tom picked up off the shelf a copy of Generic and Innovator Drugs: A Guide to FDA Approval Requirements authored by Donald O. Beers. I read it and have been in awe of it ever since.
The Eighth Edition of Generic and Innovator Drugs is a turning point for the legal treatise. Don Beers left private practice and returned to work at FDA after completing the Seventh Edition. As a result, Aspen Publishers/Wolters Kluwer sought another attorney to take on the task of serving as author and steward of the highly respected legal treatise. It is a task that I am honored to take on.
The Eighth Edition of Generic and Innovator Drugs, which will be out later this month, strives to continue the high level of discussion and analysis – specifically with regard to the Hatch-Waxman Amendments, and, more generally, with regard to the FDC Act – that readers have come to expect from the publication. Like Don, I have sought to provide a text that can be referred to on particular points as they arise, rather than a narrative that must be read from cover to cover.
The Eighth Edition introduces several changes to the treatise, including an expanded text that accounts for significant changes to the law over the past five years, such as the Biologics Price Competition and Innovation Act and the FDA Safety and Innovation Act. The Eighth Edition also includes several new appendices. While I recognize that the addition of new appendices adds to the girth of the volume, I have always found it helpful to have the relevant rules and FDA interpretations of the law at my fingertips. This is particularly true with respect to FDA’s letter decisions interpreting the statutory provisions governing marketing exclusivity relating to brand-name and generic drug manufacturers. Many of those decisions, while public, have not been placed into a single publication. Yet, they are the primary documents used by practitioners to understand how FDA currently interprets the law, especially FDA’s interpretations of the provisions governing the forfeiture of eligibility for 180-day exclusivity. I include them in the volume for the first time.
I am indebted to Don for the guidance he has provided to me through the treatise he wrote, as well as to my colleagues at Hyman, Phelps & McNamara, P.C. who have assisted me through the writing process. I am also indebted to George Johnston, who graciously agreed to write the foreword to the Eighth Edition. As George notes in his foreword, Generic and Innovator Drugs has long been considered the “go to” source on the Hatch-Waxman Amendments and pharmaceutical law. I hope to continue the tradition so well established by Don.
By Ricardo Carvajal –
FDA’s third annual report on the Reportable Food Registry (RFR) confirms the major patterns observed in the first two annual reports: foodborne pathogens and undeclared major food allergens (MFAs) continue to account for the vast majority of RFR entries (Salmonella accounted for 28.1% of entries, L. monocytogenes for 21.4%, and undeclared MFAs for 37.9%). The commodities with the largest percentage of entries for Salmonella were Produce – Raw Agricultural Commodities (RAC) (34.92%) and Nuts/Nut Products/Seed Products (12.7%). The commodities with the largest percentage of entries for L. monocytogenes were Produce – Fresh Cut (31.25%), Dairy (22.92%), and Produce – RAC (20.83%). The commodities with the largest percentage of entries for undeclared MFAs were Bakery (21.18%) and Chocolates/Confection/Candy (12.94%)
FDA notes that it is using RFR data in the agency’s implementation of the Food Safety Modernization Act ("FSMA") in various ways, such as “to identify hazards associated with products for which we have not previously made such an association and thus identify foods for which preventive controls may be needed.” FDA also signals that it might issue an ANPRM to solicit comment on how best to implement FSMA section 211. That section amends FFDCA section 417 to authorize FDA to require the posting of “consumer-oriented information” about a reportable food in certain grocery stores. Given the other FSMA-related priorities currently on FDA’s plate, it appears that implementation of FSMA section 211 is not on the near horizon.