Nutraceuticals World Breaking News

Federal Regulators Briefed on Truth in Advertising Campaign

Sean Moloughney — Fri, 06 Nov 2009 16:16:00 -0500

The Natural Products Foundation (NPF) recently met with officials from FDA and FTC to turn over the names of 10 companies that have continued to make drug or disease claims in their advertising and other promotional materials.

These meetings were part of an ongoing effort through the foundation’s Truth in Advertising (TIA) program, which aims to first educate advertisers to help them bring their advertising into compliance.

“There is no excuse for companies to be making drug and disease claims given the many ways they can find out how to make their materials compliant,” said Marc Ullman, industry regulatory attorney of Ullman, Shapiro & Ullman, and chair of the NPF Legal Advisory Council. “When we notify a company about non-compliant ads and they continue to make illegal claims, they need to know that isn’t the end of the matter—there are repercussions.”

Mr. Ullman attended the meetings with NPF executive director Tracy Taylor. According to Ms. Taylor, both agencies were “very receptive and offered encouragement for our self-regulatory efforts.”

“The good news, which we reported during our meetings, is that out of the 21 companies that have received letters as part of the Truth In Advertising program, several have already undertaken substantial efforts to bring their advertising into compliance—including taking down a website, ” she said. “In addition to the TIA material we turned over to the FDA and FTC, we have also provided those agencies with information concerning seven other websites making serious disease treatment claims—including H1N1 cures—as we believe that this type of claim requires an immediate regulatory response.”

Under the TIA program, the foundation embraces the basic principles that any advertisement or marketing materials must be truthful, not misleading, and substantiated under the requirements of both the Federal Food Drug and Cosmetic Act (FDCA) as amended by Dietary Supplement Health and Education Act (DSHEA) and the Federal Trade Commission Act:

• Not making claims, either expressly or implied, that are not accurate and fail to adequately disclose qualifying information

• Verifying that there is adequate substantiation for claims being made, including the level of support, type and quality of evidence presented, and relevance of the evidence to the claim.

• Not making claims through testimonials or expert endorsements that cannot be substantiated.

• Ensuring that claims based on traditional use have the appropriate substantiation or clearly communicate that the sole basis for the claim is its history of use for a particular purpose.

• Ensuring that claims are appropriate for dietary supplements and do not cause the product advertised to be a "drug" under the FDCA.

• Using the two-part disclaimer as stipulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994 when appropriate.

• Strictly adhering to the use of "third party literature" as defined by DSHEA.

The program, which is funded by industry companies, includes extensive educational information on the foundation’s website to assist companies in need of guidance: Truth in Advertising Resources.

“While enforcement is vital, our first goal remains to educate and assist advertisers in becoming compliant,” said Randy Dennin, chairperson of the Natural Products Foundation.“I am gratified that a number of companies that received our TIA letters are working hard to come into compliance. We are committed to leveling the playing field for ethical, trust-worthy supplement manufacturers.”

Kellogg to Drop Immunity Claims from Rice Krispies

Sean Moloughney — Thu, 05 Nov 2009 08:27:00 -0500

Kellogg Company, Battle Creek, MI, has decided to discontinue immunity statements on Kellogg's Rice Krispies cereals following criticism, detailed in mainstream media, that its claims played on fears of H1N1.

The city of San Francisco sent a letter to Kellogg and FDA recently, asking the company to support its claim that the cereal “Now Helps Support Your Child’s IMMUNITY.”

The company said it began adding increased amounts of antioxidant vitamins A, B, C and E to Rice Krispies cereals last year in an attempt to respond to parents desire for more positive nutrition in kids' cereal. However, while science shows that these antioxidants help support the immune system, given the public attention on H1N1, the company decided to make this change.

“The communication will be on pack for the next few months as packaging flows through store shelves,” the company said in a press release. “ We will, however, continue to provide the increased amounts of vitamins A, B, C and E (25% Daily Value) that the cereal offers. We will continue to respond to the desire for improved nutrition, and we are committed to communicating the importance of nutrition to our consumers.”

FTC Sues Companies for ‘Baseless’ Weight-Loss Claims

Sean Moloughney — Wed, 04 Nov 2009 08:59:00 -0500

The U.S. government has charged three companies and two individuals with making advertising claims for their fat and weight-loss pills, Relacore and Akävar 20/50, that violate a 2006 FTC order barring them from making health or weight-loss claims without a reasonable basis.

The U.S. Justice Department, at the request of the Federal Trade Commission, filed the suit in federal court.

The defendants made claims such as “eat all you want and still lose weight,” and “And we couldn’t say it in print if it wasn’t true!” on product packaging, on the Internet, and in widely read magazines such as Redbook, Star, and Family Circle. The Commission seeks to stop the defendants from making such claims and make them pay civil penalties.

“The Federal Trade Commission ordered the defendants to stop making baseless and bogus advertising claims,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection. “We wouldn’t put our orders in writing if we weren’t going to enforce them.”

The government’s complaint alleges that Basic Research, LLC, Carter-Reed, LLC, Dennis Gay, and Mitchell Friedlander have advertised Relacore by claiming, without competent and reliable scientific evidence, that it reduces “stress-induced” abdominal fat more than diet and exercise alone, and reduces abdominal fat in those who diet and exercise but retain fat due to stress from dieting.

According to the complaint, Basic Research, Dynakor Pharmacal, LLC, Mr. Gay, and Mr. Friedlander also have claimed, without a reasonable basis, that Akävar 20/50 lets you “eat all you want and still lose weight,” and that it automatically restricts caloric intake with no willpower required of users to limit food or caloric intake. They also have misrepresented scientific research by claiming that a test proves those claims, and that the product causes substantial weight loss and causes weight loss for virtually all users.

“The government alleges that these defendants made claims that their product would allow you to ‘eat all you want and still lose weight’ without a reasonable basis,” said Tony West, assistant attorney general for the Department of Justice’s Civil Division. “Claims like these are harmful to both the health and pocketbooks of those who use these supplements. Working with our partners at the Federal Trade Commission, we will continue to challenge unlawful advertising claims.”

United States Attorney Brett Tolman said, “The U.S. Attorney’s Office takes a dim view of unlawful claims in the marketplace, especially when they involve companies and individuals ordered by the FTC not to make the claims.”

In 2006, the Commission ordered Basic Research, LLC to pay $3 million on behalf of six companies and three principals, including Mr. Gay and Mr. Friedlander. The Commission’s order settled FTC charges that their deceptive weight-loss claims violated federal law, and it prohibited them from making unsubstantiated health or weight-loss claims and misrepresenting the results of scientific studies in the future. Violations of FTC orders carry a civil penalty of up to $16,000 per violation.

FDA Initiates Recall of Supplements Containing ‘Steroids’

Sean Moloughney — Wed, 04 Nov 2009 08:50:00 -0500

As FDA continues to focus on steroids in supplement products, Bodybuilding.com, LLC is recalling all lots and expiration dates of 65 dietary supplement products sold through the company's website.

FDA has informed the company that it believes the recalled products contain ingredients that are steroids. Specifically, FDA has advised the company of its concern that the recalled products may contain the following ingredients that are currently classified, or FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol."

The company has not received any reports of adverse events to date in connection with the recalled products. Because of the possible harmful effects of using products containing steroids, the Company is cooperating with FDA to conduct a recall of the products the agency has identified as containing steroids.

Prior to agreeing to carry the recalled products, the company received assurances from all manufacturers that these products were properly classified as dietary supplements in compliance with federal law, meaning that these products did not contain any unlawful ingredient.

Any adverse events that may be related to the use of the recalled products should be reported to FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postagepaid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA- 0178].

Recalled products include:

4Ever Fit D-Drol
Advanced Muscle Science Dienedrone
Advanced Muscle Science Liquidrone UTT
Anabolic Xtreme Hyperdrol X2
APS (aka Advanced Muscle Science) Mastavol
APS (aka Advanced Muscle Science) Revamp
APS (aka Advanced Muscle Science) Ultra Mass Stack
APS (aka Advanced Muscle Science) Ripped Stack
Better Body Sports Finadex
Black China Labs Straight Drol
Black China Labs Straight Phlexed
Body Conditioning Solutions TestraFLEX
Bjorklund Methyldrostanolone
BOSC Enterprises Epi-Tren
BOSC Enterprises Magna Drol
Chaparral Labs Epivol
Chaparral Labs Pheravol-V
Competitive Edge Labs M-Drol
Competitive Edge Labs P-Plex
Competitive Edge Labs X-tren
Diabolic Labs Epio-Plex
Diabolic Labs Finabolic 50
Diabolic Labs Revenge
Ergopharm 6-OXO
Ergopharm 6-OXO Extreme
EST (aka Engineered Sports Technology) MethAnstance
Extreme Labs Susto-Test Depot
Fizogen ON Cycle II Hardcore
G.E.T/ (Genetic Edge Technologies) SUS-500
G.E.T/ (Genetic Edge Technologies) Tren-250
Hardcore Formulations T-Roid
I Force Nutrition 1,4 AD Bold 200
I Force Dymethazine/Reversitol Combo Pack
I Force Reversitol
I Force Nutrition 17a PheraFLEX
I Force Nutrition Dymethazine
I Force Nutrition Methadrol
IDS (aka Innovative Delivery Systems) Bromodrol
IDS (aka Innovative Delivery Systems) Grow Tabs TR
IDS (aka Innovative Delivery Systems) Mass Tabs
IDS (aka Innovative Delivery Systems) Oxodrol Pro
IDS (aka Innovative Delivery Systems) Ripped Tabs TR
IDS (aka Innovative Delivery Systems) Rapid Release
Ripped Tabs
Kilo Sports Massdrol
Kilo Sports Phera-Mass
Kilo Sports Trenadrol
Monster Caps Monster Caps
Myogenix Spawn
Nutra Coastal D-Stianozol
Nutra Coastal H-Drol
Nutra Coastal MDIT
Nutra Coastal S-Drol
Nutra Coastal Trena
Performance Anabolics Methastadrol
Performance Anabolics Tri-Methyl X
Purus Labs E-pol Inslinsified
Purus Labs Nasty Mass
Rage RV2
Rage RV3
Rage RV4
Rage RV5
Redefine Nutrition Finaflex 550-XD
Redefine Nutrition Finaflex Ripped
Transform Supplements Forged Extreme Mass
Transform Supplements Forged Lean Mass

Kellogg's Immunity Claim Stirs Criticism

Sean Moloughney — Tue, 03 Nov 2009 15:49:00 -0500

Critics are challenging new claims from Kellogg Company that its Cocoa Krispies cereal “Now Helps Support Your Child’s IMMUNITY.”

As reported in a recent USA Today article, the nation's largest cereal maker has been accused of misleading and deceiving parents of young children, while capitalizing on fears of the H1N1 virus.

The USA Today article quotes Kelly Brownell, director of Yale University's Rudd Center for Food Policy and Obesity, as saying: “[Of all claims on cereal boxes] this one belongs in the hall of fame. By their logic, you can spray vitamins on a pile of leaves, and it will boost immunity."

The article also notes that food manufacturers recently voluntarily halted their own "Smart Choices" nutrition label program after federal regulators expressed concern that it may mislead consumers.

San Francisco sent a letter to Kellogg and FDA recently, asking the company to support its claim. FDA has yet to comment on the situation.

"I am concerned the prominent use of the immunity claims to advertise a sugar-laden chocolate cereal like Cocoa Krispies may mislead and deceive parents of young children," city attorney Dennis Herrera told USA Today.

Kellogg maintained that its claims are not meant to capitalize on swine flu fears, and that it has increased amounts of vitamins A, C and E in its cereal line, which includes Rice Krispies, from 10% of the daily value to 25% due to consumer demand and scientific research.

Executives See Challenges and Opportunities for Industry

Sean Moloughney — Mon, 02 Nov 2009 14:42:00 -0500

The dietary supplement industry will face many opportunities and challenges within the coming year, according to leading industry executives, who participated in a panel discussion, “The View From The Top” on the final day of The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry, held recently at the Terranea Resort in Rancho Palos Verdes, CA.

The panel discussion included moderator, Steve Mister, president and CEO, Council for Responsible Nutrition (CRN); Connie Barry, president and CEO, Pharmavite LLC; James Hyde, CEO, Albion Laboratories; and Douglas Lioon, executive chairman, Douglas Laboratories.

According to the panel, the current state of the economy is having a positive impact on the dietary supplement industry. Consumers are continuing to utilize dietary supplements as an important part of their health program, said Ms. Barry. Mr. Lioon agreed, noting that though there has been robust growth in the dietary supplement business, the industry certainly does not take that for granted. “People are worried about themselves and their health. The year 2009 has been good for the dietary supplement industry; we look forward to 2010,” added Mr. Hyde.

Education will be critical in coming years, according to experts, and more companies are beginning to allocate money for consumer education. Consumers want to understand more about their health, said Ms. Barry, adding that an educated consumer—one who understands the role dietary supplements play in health and wellness—leads to a consumer more willing to spend money on the products.

Mr. Lioon, whose company manufactures products for the healthcare professionals channel, noted that, “There is an abundance of information out there and consumers are demanding that information. We need to put out good products with clinically backed ingredients. The more science they see about supplements, the more they become believers.”

With GMPs in place for the majority of the dietary supplement industry, Mr. Mister asked panelists whether the new regulations have changed their businesses. Mr. Hyde said his company is not doing anything drastically different. “We embrace the GMP regulations and use it as a strategic advantage,” he said. “It is a few bad actors that give the industry a bad name.”

Mr. Lioon added that companies, such as his, who do business internationally, have to be cognizant of all the different regulations globally, making it necessary to raise the bar on all products. “We have built a brand around quality,” said Mr. Lioon.

Ms. Barry noted the fact that Joshua Sharfstein, MD, principal deputy commissioner, FDA, was willing to speak at CRN’s annual conference, was a good indication that the regulatory agency was open to collaboration and dialogue with the dietary supplement industry to help ensure high-quality, safe products for consumers. “That’s why I get up in the morning—to give consumers products that can benefit their lives,” said Ms. Barry.

Food safety regulation will continue to be another important regulatory matter. Mr. Mister noted that CRN had recently announced support of S. 510, the Senate’s bill for the FDA Food Safety and Modernization Act, which would include annual registration of facilities and mandatory recall authority for FDA.

Mr. Mister asked panelists whether or not the passage of this legislation could have a large impact on the dietary supplement industry. “If there is a perception change in how the industry is regulated, then it is probably a good thing,” Mr. Hyde said.

Ms. Barry said she wished Congress, FDA and the industry could use the tools already in place under the law before going forward with new legislation, but she also noted that food safety is an important issue that needs to be addressed.

Mr. Mister also asked panelists how new investors will be using capital and credit to enter the dietary supplement industry and what effect that will have on the industry as a whole. Mr. Lioon cautioned that, “There are two types of investors—the ones that get it and the others that are just looking to make an investment and profit quickly and flip their business.”

Mr. Hyde commented that there will be some companies looking for short-term profit, not worrying about the long-term health of the industry. To counter this, he suggested the industry needs to raise the bar in terms of accountability so that there is a balance between profit this quarter and long-term growth. He urged companies to work hard to meet somewhere in the middle on these goals.

In terms of offering advice to industry newcomers, Mr. Hyde said having a good platform and a strong foundation is essential to success. Ms. Barry proposed that start-up companies need a clear vision of who they are. “A core understanding and a commitment to quality will take them a long way,” she said.

Mr. Mister concluded the session by asking the leading CEO’s what one thing keeps them up at night. Mr. Lioon noted that the fear of a new economic contaminant that finds its way into the supply chain is one of his biggest fears. He went on to encourage companies that see something that doesn’t make sense, to step up and raise their hands and report it. “We all need to take responsibility for, and protect, our own real estate,” he said.

Ms. Barry said her biggest fear is that industryas an industry, she worries that we won’t take the opportunities for growth around us seriously, warning that companies who see growth must also strive to maintain responsibility. “I do feel that the industry we make today will set us up for the industry that we become in the future,” said Ms. Barry.

FDA Says P&G Unlawfully Marketing Vicks Cold and Flu Medicines

Sean Moloughney — Fri, 30 Oct 2009 13:44:00 -0500

FDA has sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.

The letter comes about 15 days after the agency removed an original notice from its website, saying it was posted “due to a computer error.”

Both of the over-the-counter (OTC) medicines in question, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. FDA took the action against the Cincinnati-based company: to clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective; and because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.

Under its OTC monograph system, FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed, according to the agency.

FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.

Global Probiotics Council Offers Research Grants

Sean Moloughney — Fri, 30 Oct 2009 13:32:00 -0500

For the third consecutive year, the Global Probiotics Council (GPC) is offering two $50,000 grants to rising young investigators in the field of probiotics.

GPC was formed by DANONE and Yakult Honsha Co., Ltd., and is designed to contribute to the advancement of probiotics and gastrointestinal microbiota research in the U.S.

The Young Investigator Grants for Probiotics Research are expected to continue expanding knowledge about probiotics that may benefit health and prevent disease while supporting young researchers who will focus on the relationship between probiotics, gastrointestinal microbiota and the body.

"The quality of applicants and the caliber of science that we saw the past two years were exceptional and we expect to see the same this year as the level of interest in probiotics continues to rise with emerging science," said Sven Thormahlen, executive vice president R&D, Danone Research.

DANONE and Yakult Honsha Co., Ltd. are the leading global companies involved in research about probiotics and in raising awareness about their health benefits through science-based education.

"We hope this program has a global reach. In Japan, we have a long history of working with probiotics and we are committed to supporting education and raising awareness on their benefits," said Yoshihiro Kawabata, senior managing director, Yakult Honsha Co., Ltd.

Probiotics are defined as live microorganisms that can provide health benefits to humans beyond basic nutrition when they are consumed in sufficient quantities. In the U.S., probiotics are mainly recognized for improving digestive health and supporting the immune system, but they are also involved in promoting health in many other ways. Research shows that different probiotics (specific strains) are beneficial for a number of different conditions. These grants will help to uncover additional beneficial probiotics and will identify critical mechanisms by which they are promoting health.

Application procedures and additional details on the Young Investigator Grant for Probiotics Research program can be found at www.probioticsresearch.com.

FDA and WebMD Expand Health Information Partnership

Sean Moloughney — Fri, 30 Oct 2009 08:15:00 -0500

FDA and WebMD Health Corp. have expanded their partnership to provide increased access to FDA's consumer health information. This second phase of the partnership includes expanded content and multimedia tools at www.webmd.com/fda. WebMD is personalizing FDA health information for consumers with five new online FDA sections that will initially focus on allergies and asthma, children's health, diabetes, heart health and vitamins and supplements.

"We see partners like WebMD as critical to helping us reach the public with important health information," said FDA commissioner Margaret Hamburg, MD.

FDA and WebMD initially launched their joint effort in December 2008. FDA's information is also located within WebMD's homepage, www.webmd.com, WebMD Health News, WebMD Health Search, RSS feeds, and targeted WebMD Newsletters and Special Reports.

Since the launch, more than 150,000 consumers have accessed the FDA destination on WebMD for health and wellness information on issues ranging from egg safety to contact lens safety to medicine safety. The FDA's consumer information is also available through WebMD the Magazine, distributed ten times a year and reaching an additional 11 million consumers with each issue.

"WebMD is proud to partner with the FDA to help Americans live healthier lives," said Wayne Gattinella, WebMD president and CEO. "This collaboration provides health-minded consumers with access to the FDA as a source of timely health information focusing on daily issues such as food safety and the safe use of prescription drugs, over the counter medications, and cosmetics."

New Study to Explore Gut Health and Disease

Sean Moloughney — Thu, 29 Oct 2009 14:57:00 -0500

Gastroenterologists at Rush University Medical Center will chart the presence of microorganisms found the gut and explore how microbial imbalances may impact diseases like breast cancer in a new study funded by the U.S. Department of Defense.

The human body contains billions of microorganisms, and microbial cells found in the human gut are estimated to outnumber human cells by 10 to 1 in healthy adults.However, little is known about the ways in which these minute life forms influence health and disease.

“Similar to what has been done with human DNA, we want to map out the composition of these microorganisms from their DNA and analyze how they correlate to diseases and changes within the immune system,” said Dr. Ece Mutlu, gastroenterologist at Rush and principal investigator of the study. “If we are able to find the microbes responsible for particular diseases, it may increase the likelihood of developing new diagnostic tests and treatments for diseases like breast cancer.”

Unlike the more than 20,000 genes found in the human genome, the bacterial genomes, known as the microbiome, can rapidly evolve under the pressure of changing environmental factors. Therefore, changes in the gastrointestinal microbiota have the potential to explain rises in breast cancer incidence, which are difficult to attribute to alterations in the human genome alone.

About 20-25% of the risk of developing breast cancer is related to family history. Unfortunately, the known breast cancer susceptibility genes such as BRCA2 and BRCA 2 explain less than 5-10% of the total breast cancer cases attributable to familial factors.

Researchers are exploring the possibility that the gut microbiome passed on from mother to child may be another familial factor previously never accounted for in the genetic risk models.

“The currently recognized environmental risk factors are estimated to account for only 40% of the variance in breast cancer incidence, “said Dr. Mutlu. “There is a large body of evidence implicating that dietary factors such as alcohol, high fat foods are also possible breast cancer risk enhancers, and fruits and vegetables are protective.”

Therefore, the gastrointestinal microbiota also has been overlooked as a potential, major risk factor for breast cancer compared to better known genetic and environmental risk factors.

Researchers are also analyzing the effects of gut microbiome on carcinogens and sex hormone metabolism based on evidence that the gastrointestinal microbiota has an impact on estrogen balance and is important in estrogen metabolism. This might also enhance the knowledge of other sex hormone related diseases such as ovarian cancer, osteoporosis and endometriosis.

Supported by more than $1 million in grants from the Department of Defense and National Institutes of Healthy (NIH), Dr. Mutlu and her team are currently collaborating with Dr. Patrick Gillevet, at the MicroBiome Analysis Center, a new molecular ecology facility at George Mason University in Fairfax, VA, to chart the presence of microorganisms in patients suffering from breast cancer, Crohn’s Disease, inflammatory bowel disease, cirrhosis of the liver and HIV.

Researchers will be using a technology for genomic sequencing called Multitag Pyrosequencing (MTPS) that allows them to examine, count and barcode hundreds of thousands of microorganisms per day within samples taken from various ecological systems including the human body. Because of this new technology for genomic sequencing, researchers will be able to identify 50,000 or 60,000 microbes per sample.

Rush is currently recruiting study participants who are female, 30 years of age or older, and newly diagnosed with breast cancer before any treatment has begun. Clinical data from the participant’s medical records will be taken. Before a patient receives any cancer-related therapy, biopsies of the colon and stool specimens will be taken.

Vitamin Shoppe, Inc. Prices Initial Public Offering

Sean Moloughney — Wed, 28 Oct 2009 16:08:00 -0500

North Bergen, NJ-based Vitamin Shoppe, Inc. announced the public offering of 9,096,077 shares of its common stock has priced at $17 per share. The shares will begin trading on the New York Stock Exchange under the ticker symbol "VSI."

Vitamin Shoppe is offering 7,666,667 shares of common stock and selling stockholders are offering the remaining 1,429,410 shares in the offering. The underwriters have a 30-day option to purchase up to an additional 1,364,411 shares from the selling stockholders.

Vitamin Shoppe intends to use the net proceeds of approximately $121 million from the offering for the pro rata redemption of approximately $72.5 million of its outstanding preferred stock, the repurchase of approximately $45 million in aggregate principal amount of its outstanding senior secured notes, and the payment of offering-related expenses.

J.P.Morgan, BofA Merrill Lynch and Barclays Capital are acting as joint book-running managers for the offering. Piper Jaffray, Robert W. Baird & Co. and Stifel Nicolaus are the co-managers of the offering.

Smart Choices Program Postpones Active Operations

Sean Moloughney — Tue, 27 Oct 2009 11:22:00 -0500

The Smart Choices Program will voluntarily postpone active operations and not encourage wider use of the logo by either new or currently enrolled companies, following FDA announcement that it intends to develop standardized criteria on which future front-of-package nutrition or shelf labeling will be based.

In a letter captioned, "Guidance for Industry" and posted on its website, FDA stated: "We want to work with the food industry retailers and manufacturers alike as well as nutrition and design experts and the Institute of Medicine, to develop an optimal, common approach to nutrition-related FOP...that all Americans can trust and use to build better diets and improve their health."

"We welcome the FDA's interest in developing uniform front-of-package and shelf-labeling criteria," said Mike Hughes, chair, Smart Choices Program and vice president for science and public policy at the Keystone Center. "The Smart Choices Program shares that exact goal, and was designed to provide a voluntary front-of-package labeling program that could promote informed food choices and help consumers construct healthier diets. We continue to believe the Smart Choices Program is an important step in the right direction."

The Smart Choices Program will also continue to work with those who have an interest in front-of-package labeling, such as Connecticut Attorney General Richard Blumenthal, who has asked for information about the development of the program, which the group is providing.

The Smart Choices Program was developed, in part, to respond to earlier governmental calls for a more uniform, voluntary, front-of-package labeling program.

"Our nutrition criteria are based on sound, consensus science," said Mr. Hughes. "But with the FDA's announcement this week that they will be addressing both on front-of- package and on-shelf systems, and that uniform criteria may follow, it is more appropriate to postpone active operations and channel our information and learnings to the agency to support their initiative."

"The Smart Choices Program stands ready to work with and support the FDA, U.S. Department of Agriculture (USDA) and the Institute of Medicine in this effort," he added.

The Smart Choices Program was developed during an open and lengthy collaborative process by a diverse coalition of scientists, nutritionists, public health and public interest organizations and food industry leaders.

The program's nutritional criteria are based on the U.S. government's Dietary Guidelines for Americans and the labels comply with all U.S. laws and regulations.

Sharfstein Says FDA and Industry Must Work Together

Sean Moloughney — Mon, 26 Oct 2009 08:38:00 -0500

Joshua Sharfstein, MD, principal deputy commissioner of FDA, offered remarks at the Council for Responsible Nutrition Annual Conference, saying the agency and the industry must continue working together to protect consumers.

“We have worked together to implement new provisions mandating reporting of serious adverse events,” he noted. “Implementation of these provisions will help the agency identify unsafe products, warn the public about them and remove them from the market. We also worked together to develop dietary supplement current good manufacturing practice requirements. These requirements will enhance the quality of the products provided to consumers.”

However, much more work needs to be done, he added. “There are products marketed as dietary supplements today that pose serious risks to consumers—in some cases, life-threatening risks. Addressing this problem is critical for consumer health and for consumer confidence in the dietary supplement industry.”

Dr. Sharfstein said the issue of dietary supplements spiked with potentially dangerous pharmaceuticals remains one of FDA’s biggest concerns.

“The steroid problem is the most high profile safety issue facing the nation’s supplement supply,” he said. “Recently, at a hearing before the Senate Judiciary Committee, the chief executive officer of the U.S. Anti-Doping agency testified that elite athletes are ‘testing positive for banned drugs because they were taking products that were either accidentally contaminated or purposefully spiked by manufacturers with designer steroids, stimulants, or other drugs’.”

Dr. Sharfstein said the agency has committed substantial resources to confront the situation. “We intend to continue this aggressive enforcement and education. But given the scale of the problem, these steps alone will not be enough. What else can be done? Recently, the American Herbal Products Association suggested to FDA that the solution to steroids was to use the same strategy we are using to fight fraud related to H1N1 influenza. However, there are significant legal barriers to applying this same strategy to supplements.”

For example, FDA can act against fraudulent H1N1 products as soon as unlawful claims are identified. However, to take action against supplements containing steroids, FDA must often demonstrate that steroid ingredients are present, which can be complicated at times. “We must develop new tools and approaches to succeed,” Dr. Sharfstein said. “An important step is to develop all the tools DSHEA gives us for improving the safety and quality of dietary supplements. One such tool is the agency’s ability to review new dietary ingredients, or NDIs.”

“Although DSHEA excludes from premarket notification ‘grandfathered’ dietary ingredients that were marketed before DSHEA became law, dietary supplements that contain new dietary ingredients must submit a 75-day pre-market notification to FDA,” he continued. So far, we have been hampered by the fact that no verified list of grandfathered ingredients exists. But here’s what we can do. We can set out guidance explaining how to demonstrate that a product is in fact grandfathered in. Then, when we see concerning products we do not believe were marketed prior to October 15, 1994 on the market, we can ask companies to provide evidence of prior marketing, or to voluntarily pull the product until an NDI premarket notification is filed.”

Looking forward, Dr. Sharfstein said the safety of the supply chain in an increasingly globalized world is a top concern.

“Because you are ultimately responsible for the product you put on the market and its impact on consumers, every company in the supplement industry should be responsible for where you are purchasing their ingredients,” he said. “When you find problems, you should notify the FDA, so we can take action to prevent these ingredients from being sold by other companies in your industry.”

Consumers Value Supplements Despite Tough Economy

Sean Moloughney — Fri, 23 Oct 2009 13:55:00 -0500

Despite challenging economic times, 65% of adult consumers (up slightly from 64% in 2008) take dietary supplements, according to a new consumer survey conducted by Ipsos-Public Affairs for the Council for Responsible Nutrition (CRN), Washington, D.C.

When asked if the economy had impacted their household’s dietary supplement purchasing habits, nearly three-quarters (74%) of those surveyed responded that it had not.

“We’re pleased that consumers continue to place emphasis on their health, even in uncertain economic times, and that dietary supplements continue to play a role in their overall wellness regimen,” said Judy Blatman, senior vice president, communications, CRN. “According to our survey, consumers, including supplement users, report to be taking necessary steps towards good health, such as trying to eat a balanced diet and getting regular exercise. We’re encouraged that dietary supplements continue to be a part of that equation for many.”

According to results from the 2009 CRN Consumer Survey on Dietary Supplements, the economy prompted 27% of dietary supplement consumers to alter their supplement purchasing habits.Among that group, purchasing habits changed in the following ways:
59% (of the 27%) reported they are purchasing fewer supplements as a means to save money;

31% (of the 27%) indicated they are now purchasing less expensive brands;

26% (of the 27%) said they have been purchasing store brand supplements;

23% (of the 27%) indicated they rely on coupons and other value-added promotions;

22% (of the 27%) responded they only buy supplements when they are on sale;

5% (of the 27%) responded they are purchasing more supplements to maintain health;

4% (of the 27%) responded they have stopped purchasing supplements because of the economy. Supplement consumers indicated that the three factors most important to them when purchasing supplements are: the price, the supplements facts box (i.e. dosage, daily value, etc.) and the label claims (e.g., maintain heart health, maintain joint health, etc).

The 2009 CRN Consumer Survey on Dietary Supplements was conducted August 26 through September 1, 2009 by Ipsos Public Affairs and funded by CRN. The survey was conducted online and included a national sample of 2043 adults aged 18 and older from Ipsos’ U.S. online panel. The survey has been conducted annually since 2000.

Index Tool Evaluates Affordable Nutrition

Sean Moloughney — Fri, 23 Oct 2009 13:41:00 -0500

A new food rating system that analyzes both nutrition and cost value of food may now make it easier for people to find budget-friendly, nutritious foods in today’s tough economy.

The Affordable Nutrition Index (ANI), unveiled today at the American Dietetic Association`s Food and Nutrition Conference and Expo by leading nutrition expert Adam Drewnowski, PhD, professor at the University of Washington, assesses food’s nutritional profile and cost value to create a nutrition-value-per-dollar score.

The ANI is guided by recommendations in the U.S. Dietary Guidelines for
Americans and calculates a food score based on nine essential nutrients to encourage (protein, fiber, iron, calcium, potassium, magnesium, and vitamins A, C and E) and three nutrients to limit (saturated fat, added sugars and sodium).

Nearly 300 commonly eaten foods, including fresh vegetables, fruits, grains from an independent food intake frequency questionnaire, and various convenience foods, including a variety of Campbell’s soups, were assessed in the study. Results showed that dark colored vegetables, certain fruits and vegetable soups were among the most affordable, nutritious foods.

"In today’s economy, more people are making food choices based solely on cost, so it’s important to guide them on ways to get nutritious options without hurting their wallets," said Mr. Drewnowski. "It is important to identify a wide range of affordable, nutritious choices that can help people build a balanced diet that fits their lifestyle and budget."

In Mr. Drewnowski’s analysis, the ANI ranked two dozen soups as comparable to—and in some cases, higher than—many common fruits and vegetables. Mr. Drewnowski concluded that based on nutrition and price value, vegetable soups can be a convenient way to help people eat a more healthful, yet affordable, diet consistent with Dietary Guidelines. This new research further validates the importance of including affordable choices across multiple categories of nutritious fresh and prepared foods.

Other findings include:

Carrots, sweet potatoes and broccoli were at the top of the ANI scale; oranges and bananas were the top-scoring fruits in the index.

Twenty-five Campbell’s soups followed closely on the ANI scale, particularly condensed vegetable soup varieties that are lower in sodium, like Campbell’s Healthy Request condensed vegetable soup, which is certified as heart-healthy by the American Heart Association, and Campbell’s Tomato soup, which recently underwent a 32% reduction in sodium and is one of the top-selling soups in the U.S.

Other fresh or cooked vegetables (peas, string beans, squash, lettuce) and fresh fruits (raspberries, blackberries, strawberries, grapes, nectarines, apples) were also highly ranked.