Nutraceuticals World Breaking News

UNPA Commends FDA Actions Against Steroids

Sean Moloughney — Fri, 20 Nov 2009 16:46:00 -0500

The United Natural Products Association (UNPA) commended FDA action to recall five products illegally marketed as sports enhancing dietary supplements.

Loren Israelsen, executive director, UNPA, commented, “this is a significant step to assure safety in the dietary supplement marketplace, and we commend Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein for following through on their commitment to steer the agency toward stronger enforcement of the nation’s dietary supplement laws.

“It is clear to us that the five products the FDA recalls—Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR—have been illegally marketed as dietary supplements, since they contain undeclared steroid substances, which under law are considered to be drugs. The FDA’s action is an essential step in weeding out unscrupulous products from the dietary supplement marketplace, and UNPA pledges to continue working with federal regulators to achieve this mutual consumer safety objective.”

The United Natural Products Alliance (UNPA) is an association of dietary supplement and functional food companies, both manufacturers and analytical laboratories, that share a commitment to provide consumers with natural health products of superior quality, benefit and reliability.

Sports Nutrition Spotlighted at Congressional Briefing

Sean Moloughney — Thu, 19 Nov 2009 16:40:00 -0500

Sports nutrition continues to be a hot topic both in Congress and the news. Because the physical stress from intense exercise increases an athlete's nutrient needs and depletes electrolytes, vitamins and other supplements play a vital role for athletes. However, legal dietary supplements, which are used by more than 150 million Americans, should not be confused with illegal anabolic steroids.

Recognizing this, the Congressional Dietary Supplement Caucus, in cooperation with the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), recently hosted a speaker lunch briefing, “Sports Nutrition and Dietary Supplements.” This was the fifth in a series of speaker briefings since the inception of the Dietary Supplement Caucus in 2005. The speaker briefings are intended to educate Congressional staffers on important issues related to the safety and benefits of dietary supplements.

“There is a great deal of misinformation that gets circulated in the press and by athletes and this is a good opportunity to hear the facts from the experts,” said John Gay, executive director and CEO, Natural Products Association.

Douglas S. Kalman, Ph.D., R.D,, a director at Miami Research Associates,spoke to nearly 70 attendees at the Dietary Supplement Caucus lunch briefing about the importance of proper nutrition for athletes and addressed concerns regarding steroids in dietary supplements. Kalman stressed that a proper diet and maintaining proper hydration were key to athletic training. “When it comes to issues surrounding sports nutrition, I really like to drive home the point that it is food first, fortified foods next, and supplements with products that are geared toward promoting health, recovery and nutrition, come after,” Dr. Kalman said.

Dr. Kalman also addressed the issue of athletes who test positive for illegal, anabolic steroids and then point the finger at a dietary supplement, often without any proof. He noted that there are many laws and regulations in place, including the good manufacturing practices specific to dietary supplements, which mandate that what is on the label is in the bottle and vice versa.

Steve Mister, president and CEO, CRN, who was also present at the briefing, added that “In the vast majority of cases, when an athlete blames a dietary supplement, that accusation does not pan out and it turns out that an athlete has used the dietary supplement as a scapegoat.However, there have been times when illegal steroids have been found in products marketed as dietary supplements—and let’s make this clear—illegal steroids have no place in dietary supplement products. People who put illegal substances in those products are criminals.”

Dr. Kalman agreed, noting, “The dietary supplement industry is a very active industry and an ethical industry, but for those companies that sell adulterated products or drugs masked as dietary supplements, hopefully all legal actions that are available [to FDA] are taken against them.”

Dr. Kalman then went on to review beneficial supplementation for athletes and provided greater insight into how experts can convey appropriate messages about training, nutrition and the use of safe and legal dietary supplements to athletes. He then fielded questions on a range of topics from how to handle the issue of using sports supplements with young and teen athletes, to recent concerns about vitamin D deficiency in the United States.

Though Dr. Kalman’s discussion focused primarily on nutrition’s role in athletic training, co-chairs of the Congressional Dietary Supplement Caucus, Reps. Jared Polis (D-CO) and Dan Burton (R-IN), who were present at the briefing, noted that dietary supplements play an important role in the nation’s overall health and wellness. Polis noted that, “An estimated 150 million Americans, including myself and other members of Congress, use dietary supplements each year.”

The briefings will continue on a quarterly basis, focusing on topics relevant to the dietary supplement industry and wellness arena and will feature speakers who will address the latest science and offer practical information. These briefings will also serve to position the Dietary Supplement Caucus as the experts when it comes to educating Congress on dietary supplement legislation and regulation.

Study Links Folic Acid with Cancer Risk

Sean Moloughney — Wed, 18 Nov 2009 06:41:00 -0500

Treatment with folic acid plus vitamin B12 was associated with increased cancer outcomes and all-cause mortality in patients with ischemic heart disease in Norway, according to a recent study published in JAMA.

The objective of this study was to evaluate effects of treatment with B vitamins on cancer outcomes and all-cause mortality in two randomized controlled trials.

Combined analysis and extended follow-up of participants from these randomized, double-blind, placebo-controlled clinical trials (Norwegian Vitamin Trial and Western Norway B Vitamin Intervention Trial). A total of 6837 patients with ischemic heart disease were treated with B vitamins or placebo between 1998 and 2005, and were followed up through December 31, 2007.

Subjects received oral treatment with folic acid (0.8 mg/d) plus vitamin B12 (0.4 mg/d) and vitamin B6 (40 mg/d) (n = 1708); folic acid (0.8 mg/d) plus vitamin B12 (0.4 mg/d) (n = 1703); vitamin B6 alone (40 mg/d) (n = 1705); or placebo (n = 1721).

During study treatment, median serum folate concentration increased more than 6-fold among participants given folic acid. After a median 39 months of treatment and an additional 38 months of post-trial observational follow-up, 341 participants (10%) who received folic acid plus vitamin B12 vs. 288 participants (8.4%) who did not receive such treatment were diagnosed with cancer (hazard ratio [HR], 1.21; 95% confidence interval [CI], 1.03-1.41; P = .02).

A total of 136 (4%) who received folic acid plus vitamin B12 vs. 100 (2.9%) who did not receive such treatment died from cancer (HR, 1.38; 95% CI, 1.07-1.79; P = .01). A total of 548 patients (16.1%) who received folic acid plus vitamin B12 vs. 473 (13.8%) who did not receive such treatment died from any cause (HR, 1.18; 95% CI, 1.04-1.33; P = .01). Results were mainly driven by increased lung cancer incidence in participants who received folic acid plus vitamin B12. Vitamin B6 treatment was not associated with any significant effects.

Researchers concluded that treatment with folic acid plus vitamin B12 was associated with increased cancer outcomes and all-cause mortality in patients with ischemic heart disease in Norway, where there is no folic acid fortification of foods.

Responding to the study’s release, Daniel Fabricant, PhD, vice president of scientific and regulatory affairs for the Natural Products Association (NPA), Washington, D.C., said “Despite the authors’ justification for the analysis, previous review has indicated the NORVIT might not have been adequately powered and the factorial design might have been too complex, thus rendering the trial incapable of isolating the effect of folate per se. Being combined with the WENBIT, which was terminated early, and which wasn’t without its design flaws, either, creates a scenario in which two flawed studies are combined to yield one larger flawed study. This does not seem to be in the best interest of medical science or public health.”

He went on to say that that most of the subjects in both trials were also being treated with beta-blockers and statins, and some were also being treated with ACE inhibitors and diuretics, “yet there are no numbers, no analysis on the effects these interventions may have on the incidence of cancer. There is no adjustment of the baseline effect for these interventions, yet the authors adjusted the baseline for smoking, age and sex, which are all factors in the development of cancer. We have no way of determining these factors’ impact on this study as they just decided to leave that out, like ordering off of an a la carte menu.”

Andrew Shao, PhD, vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN), Washington, D.C. said it is important to note that the results from this study “are inconsistent with the larger body of data and that this effect has not been observed previously. In fact, as the authors themselves point out, ‘Epidemiological studies have demonstrated no associations between intakes of folate or folic acid and lung cancer risk’.”

He added: “Consumers, as well as researchers and healthcare professionals, must not lose sight of the safe, well-established benefits of folic acid supplementation and fortification for women of childbearing age to prevent neural tube defects, as well as other potential benefits of folic acid supplementation, such as for cardiovascular health and cognitive function in the general population.”

Probiotics Fail to Deliver Listed Ingredients

Sean Moloughney — Tue, 17 Nov 2009 10:23:00 -0500

Many probiotic supplements do not contain the number of viable organisms listed on their labels, according to a new report from ConsumerLab.com, White Plains, NY.

The testing organization found that at the time a probiotic is purchased it may contain as little as 10% to 58% of the amount listed on its label. In fact, one children’s probiotic was found to provide only 7% of its claimed bacteria. Products were also tested for microbial contaminants and pathogens, but none were found.

Out of 13 products selected for testing, only two accurately listed the number of cells viable at the time of purchase. The actual amount of viable probiotic cells in a daily serving ranged from more than 10 billion to less than 100 million—more than a 10,000% difference. Despite providing fewer viable organisms than one might expect, most products yielded at least 1 billion organisms, an amount that may provide some benefit.

Probiotics help re-populate the gut with live beneficial bacteria such as Lactobacillus acidophilus, Lactobacillus GG, Bifidobacterium infantis and others, as well as specific yeast such as Saccharomyces boulardii. Studies have shown some probiotic strains reduce symptoms of irritable bowel syndrome (IBS) and reduce diarrhea caused by viral infection or antibiotics. They may also help treat H. pylori infection (a causative agent of stomach ulcers) and vaginal bacterial infection, among other uses. Sales of probiotic supplements grew about 16% in 2008 to reach $425 million in the U.S. according to Nutrition Business Journal, Boulder, CO.

ConsumerLab.com purchased the products as a consumer would, cultured them to determine the number of viable cells, and compared the amounts found with those listed on product labels. Tests showed many products to qualify the listed amount of cells with the statement “at time of manufacture,” an unusual practice because supplements are normally expected to provide at least 100% of their listed ingredients until the expiration date. One probiotic was found to take both approaches, promoting “12 BILLION CELLS” per capsule on its front label (footnoted as being “at date of manufacture”), while its supplement facts panel guaranteed an amount through expiration that was actually 80% lower.

The study also evaluated pet probiotics. Across the products, very large differences were noted in the number of cells in the suggested daily dosage.

“Consumers should keep in mind that a large percentage of organisms in a probiotic supplement may die before a product is even purchased and labels can be misleading or incorrect,” said Tod Cooperman, MD, president of ConsumerLab.com. “Many products start with several billion viable cells, but there may or may not be a sufficient number of viable cells remaining at time of use to be beneficial.” Dr. Cooperman advised using products known to deliver an adult daily dose of at least one billion viable cells or an amount proven to be clinically effective for that strain. He suggested that products be stored in sealed containers out of heat, light, and humidity. In addition, if a label indicates that a product should be refrigerated (not just after opening) it should be sold in a refrigerated condition and kept that way.

AHPA Makes ‘Key Distinction’ in Letter to Boston Globe

Sean Moloughney — Mon, 16 Nov 2009 09:36:00 -0500

Under the headline “Key Distinction on FDA, Supplements,” the Boston Globe published a letter to the editor from Michael McGuffin, president, American Herbal Products Association (AHPA) on Nov. 13, in response to the paper’s recent editorial, “Police These Pills and Powders.”

In its Nov. 2 editorial, the Globe opines that FDA lacks adequate power to regulate dietary supplements. “Under the current law,” the Globe writes, “the FDA can take action against manufacturers of supplements with harmful ingredients only after there are reports of bad reactions among users.”

“In fact,” Mr. McGuffin explains in his letter, “synthetic steroids are not allowed in supplements, and the FDA has issued 28 warning letters since 2004 against companies marketing such products. These actions were taken based not on adverse events, but on claims made on product labels and on FDA analyses.”

The Boston Globe editorial follows and references an Oct. 15 New England Journal of Medicine (NEJM) opinion piece by Dr. Pieter Cohen, Harvard Medical School. The NEJM piece, like the Globe editorial, fails to distinguish between dietary supplements and illegal drugs, according to Mr. McGuffin, and alleges FDA does not have sufficient authority to regulate supplements. AHPA also submitted a letter to the editor of NEJM.

“Legally labeled dietary supplements are required to list every contained ingredient,” Mr. McGuffin concludes in his letter to the Boston Globe. “Any product that fails to do so is misbranded, and the FDA, under current law, can seize the product and issue warnings or bring criminal actions against its marketers.”

Federal Grant Supports Research on Botanical Identification

Sean Moloughney — Mon, 16 Nov 2009 08:31:00 -0500

The University of Illinois at Chicago has received a 2-year, $1.2 million federal grant to develop a new method of identifying the contents of botanical dietary supplements and how they work.

The research, under the leadership of Guido Pauli, associate professor of pharmacognosy, will use nuclear magnetic resonance and mass spectrometry to identify the correct plant materials used for production more quickly and accurately, and to provide more reliable assays to ensure botanical quality and safety.

The new methodology will initially test 10 of the top 20 most widely used botanicals. Among them are soy, red clover, garlic, ginkgo, Echinacea, St. John's Wort, ginseng, green tea and black cohosh. The approach will be innovative to botanical reference standards and will transform the current system of identifying natural health products, according to Dr. Pauli.

"Our new approach to quality control will allow us to measure several parameters of herbal quality simultaneously," he said. "This not only supports the more holistic approach of using botanical supplements, but can also become a protective measure for the consumer looking for products that are safe to use."

Nearly one in 10 people use botanicals, and 40% of Americans—and 12% of children under the age of 18—use complementary and alternative medicine, according to the 2008 National Health Statistics Report. U.S. adults spent nearly $34 billion out of pocket on complementary and alternative medicine products, classes and materials, and on visits to complementary and alternative medicine practitioners in 2007, the report said.

The grant is funded by the National Center for Complementary and Alternative Medicine, one of the National Institutes of Health.

Global Nutraceuticals Market to Reach Nearly $22 Billion

Sean Moloughney — Fri, 13 Nov 2009 14:20:00 -0500

The worldwide market for the entire nutraceuticals industry could total nearly $22 billion by 2013 and the U.S. will supply the greatest number of consumers, according to a new report published by the Freedonia Group.

Based on their widely publicized health benefits, high demand is expected for nutrients such as: soy proteins and isoflavones (for digestive health, lowering cholesterol and fighting off cancer); psyllium fibers (for colon health); omega 3 fatty acids (for cardiovascular health); probiotics (for gastrointestinal health); lycopene (for their antioxidant capacity); calcium and magnesium (for bone and joint health), according to the market research firm.

The report estimates that global demand for nutrients and minerals will reach nearly $13 billion by 2013. The report also projects higher demand for vitamin formulations like non-genetically engineered vitamin E and natural vitamin A (beta-carotene) supplements. Sales of multivitamins for adults and children are also expected to rise and the global demand for non-synthetic vitamins is expected to increase almost 6% annually to about $7 billion by 2013.

Herbal as well as non-herbal extracts will also see significant increases, despite ongoing controversy about their alleged health benefits, the report says. Garlic for the heart, saw palmetto for the prostate, green tea to fight cancer, black cohosh for women's health and glucosamine for bone health are slated to be the drivers in the category.

Reflecting an annual growth rate of about 6%, nutraceuticals will find their largest market in the U.S. but markets in China and India will be developing rapidly in the wake of economic growth and evolving production methods of increasingly diverse food, beverages and medicinal products.

NutraCea Files for Chapter 11 Bankruptcy

Sean Moloughney — Wed, 11 Nov 2009 12:34:00 -0500

Phoenix, AZ-based NutraCea has filed a voluntary petition for protection under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Arizona.

None of the company’s subsidiaries, including its Brazilian rice bran oil operation, Irgovel, were included in the bankruptcy filing.

The Company plans to use the protection provided by the courts under Chapter 11 to restructure its operations, reduce overhead and sell non-core assets, in line with the previously announced strategy of focusing on its core businesses of stabilized rice bran, rice bran oil, nutraceuticals and baby cereal.

"The protection provided by the Chapter 11 process will allow NutraCea to gain immediate liquidity through the $6,750,000 Debtor-in-Possession (DIP) financing facility provided by Wells Fargo Bank, N. A. and to resume normal day-to-day operations, while giving us the opportunity to restructure, strengthen our business performance and create long-term value for our stakeholders," said W. John Short, CEO. "We will work hard to emerge from this process as quickly as possible with a streamlined cost structure that should allow us to operate as a healthier, more competitive and profitable company. We deeply appreciate the dedication and efforts of our employees, who have worked exceedingly hard during this challenging period. We look forward to the continued support of our customers, vendors and business partners as we reposition NutraCea for future growth and profitability."

In conjunction with its filing, the company applied for Bankruptcy Court approval for a DIP financing facility provided by Wells Fargo Bank, N. A. The DIP facility provides lines of credit totaling $6,750,000 which, combined with cash flow from operations, will permit payment of employee wages and benefits and allow the Company to resume normal day-to-day operations, including payment of post-petition obligations to vendors and professional service providers, all in the normal course of business.

The total funds that NutraCea will be able to access under the DIP financing facility will be determined using a borrowing base formula and will be reduced by the outstanding balance owing under NutraCea’s old credit facility with Wells Fargo Bank, N.A. NutraCea currently owes approximately $3,575,000 to Wells Fargo Bank, N.A. under the old credit facility. The company’s obligations under the DIP financing facility will be secured by its facilities in Phoenix, Dillon, Montana and Mermentau, Louisiana and all of its personal property assets other than certain intellectual property assets.

In addition to seeking Bankruptcy Court approval of the DIP financing, NutraCea has filed several customary first day motions seeking authority to take actions in furtherance of its reorganization.

The Company plans to post regular updates on its website regarding the Chapter 11 process in order to keep employees, customers, vendors, professional service providers, shareholders, other stakeholders and the general public apprised of its progress as it restructures under court supervision.

Natural & Organic Cosmetic Standards Spotlighted

Sean Moloughney — Tue, 10 Nov 2009 11:51:00 -0500

The number of natural and organic cosmetic standards is proliferating, according to a report from UK-based Organic Monitor. However prospects for a global unified standard appear low.

Organic Monitor’s new Technical Insights report assesses the leading international natural and organic cosmetic standards. Although standards are gaining in popularity, adoption is mostly on a national basis, the report says. Very few standards have built a regional—let alone international—presence. Furthermore, the differences between the most popular standards in each region remain wide.

Standards are most widely adopted in Europe where almost two-thirds of all natural and organic cosmetic products are certified. Organic Monitor estimates that the market value of certified products exceeded EUR 1 billion this year. Ecocert and BDIH are the leading standards, partly because of the high adoption rates in France and Germany, respectively. Ecocert’s popularity is partially because it has a natural and organic standard, whereas most certification agencies have just an organic standard.

Although various standards have been introduced in North America over the last 18 months, very few products have become certified. Organic Monitor estimates that less than 5% of natural and organic cosmetics are certified in the region. Backed by leading natural cosmetic companies, the Natural Products Association (NPA) standard is the frontrunner. The NSF ANSI 305 “made with organic” standard is expected to gain popularity once certification begins. The absence of an organic cosmetic standard however, is leading a number of American companies to adopt the USDA NOP standard. Although designed for organic food products, it is popular with cosmetic companies that use food-grade ingredients.

Natural and organic cosmetic standards are also being introduced in other regions such as the Asia-Pacific and Latin America. The adoption rates are exceptionally low, however, Organic Monitor indicates. Many natural cosmetic companies in these regions focus on exports, making them favor European standards. The Ecocert standard has become the most popular in countries such as Japan, Malaysia and Brazil.

Organic Monitor also undertakes a critical review of new regional and international initiatives such as Cosmos and NaTrue. The practical implications of new Cosmos standard, scheduled to be implemented in January 2010, are discussed. The Cosmos standard has been developed following 7 years of negotiations between leading certification agencies in Europe; its launch is expected to mark a milestone for the European natural cosmetics industry. However, its goal of becoming an eventual European standard is facing competition from NaTrue. More than 150 products have become certified by NaTrue since the standard was launched a year ago.

IOM Petitioned to Establish Reference Intakes for Omega 3s

Sean Moloughney — Mon, 09 Nov 2009 13:55:00 -0500

The Global Organization for EPA and DHA Omega 3s (GOED) and a consortium of eight scientific, trade and consumer advocacy organizations have petitioned the U.S. Institute of Medicine (IOM) to convene an expert panel to establish clear dietary reference intakes (DRIs) for the EPA and DHA omega 3 fatty acids.

According to the groups, industry support is urgently needed to (1) provide comments of support for the initiative and (2) encourage legislators to fund the IOM review. GOED has launched a website to provide a convenient method of submitting comments and reaching legislators: www.omega3petition.org.

GOED believes newly established DRIs would have a profound effect on both the industry and consumers. “Omega 3s are one of the fastest growing and largest segments of the food and supplement business, which is why this issue impacts every company within this sector,” said Adam Ismail, executive director of GOED. “In the past decade or so, research on omega 3 fatty acids, EPA and DHA in particular, has evolved to suggest we may be facing a serious public health problem. Most Americans appear to be falling short in their consumption of EPA and DHA, which studies show are important for cardiovascular health and brain development,” added Andrew Shao, PhD, vice president, Scientific and Regulatory Affairs, Council for Responsible Nutrition, and a cosigner of the petition.

A study, in the April issue of PLoS Medicine identified EPA and DHA inadequacy as the sixth leading cause of preventable death in the U.S. Dr. Shao stated: “Taking a simple EPA and DHA-containing product could help fill the nutrition gaps, but until DRIs are established both policy makers and consumers have no way of knowing what the target intakes should be and by how much they’re falling short. By not acting on this important initiative, we place the health of Americans and Canadians at risk.”

The petition comes at an important time, as leaders on Capitol Hill are looking at healthcare reform. Prevention needs to be a primary focus in these discussions, experts argue. An investment of approximately $1-1.5 million is needed from the U.S. and Canadian governments to fund the IOM review. These recommendations could potentially result in billions of dollars in reduced healthcare costs and bring strong credibility to the entire nutrition industry, they claim.

This issue has united the interests of the industry with those of scientific and consumer groups but without funding from Congress, clear DRIs reflecting the sound science behind EPA & DHA will not be established. Organizations and individuals are strongly encouraged to show their interest and support by visiting www.omega3petition.org to submit public comments and find information on writing their legislators.

Organizations supporting the Omega 3 Petition include, Global Organization For EPA And DHA Omega-3s, Council For Responsible Nutrition, International Omega 3 Learning Consortium For Health And Medicine, National Fisheries Institute, National Healthy Mothers, Healthy Babies Coalition, Natural Products Association, Seafood Products Association, Society For Women’s Health Research and the United Natural Products Alliance.

CRN Renews Commitment to Self-Regulation

Sean Moloughney — Mon, 09 Nov 2009 13:01:00 -0500

The Council for Responsible Nutrition (CRN) and the National Advertising Review Council (NARC) will be extending the dietary supplement advertising review program established in 2006 for an additional five years.

Under the extension agreement, the National Advertising Division (NAD) of the Council of Better Business Bureaus (CBBB) will receive $959,000 from the newly-formed 501(c)(3) CRN Foundation, payable in incremental, semi-annual grants, beginning November 1, 2009 through October 31, 2014.

“Responsible industries take actions that demonstrate their commitment to protecting their consumers, and this self-regulatory program says to all companies that this industry won’t sit back and let misleading advertising serve as a hallmark for which our industry is known. In the three years this program has been in existence, it has gained momentum and widespread attention, becoming an example of responsibility for our industry,” said CRN Foundation executive director Steve Mister. “This initiative reflects one of the CRN Foundation’s objectives—‘to promote truthful and non-misleading advertising of dietary supplements to consumers through programs that encourage self-regulation of advertising by industry members’.”

“Misleading dietary supplement advertising negatively impacts trusting consumers and honest competitors alike. Left unchecked, misleading advertising will undermine the reputation of the entire industry,” said Andrea Levine, NAD director and CBBB senior vice president. “With CRN’s support, we have demonstrated that self-regulation can play an active and visible role in combating misleading and unsubstantiated dietary supplement claims, but there is still significant work left to be done. We look forward to continuing our program and are confident that it will make a real difference. CRN is to be commended for its leadership for supporting this strong, impartial self-regulatory program.”

The CRN/NAD initiative, which began in 2006, was developed to increase consumer confidence in the truth and accuracy of advertising claims for dietary supplement products and to encourage fair competition within the industry. Through a series of multi-year grants from CRN, the initiative allowed NAD to hire an additional attorney who focused solely on the dietary supplement product category. The initiative has taken aim at substantive claims that are deceptive or misleading and clearly go beyond what's supported by research and allowed by law—claims that feed the public's distrust of the supplement industry. NAD reviews advertising that is national in scope, including print, broadcast, infomercials and Internet advertising. NAD opens cases following complaints from consumers, competitors and pursuant to its own monitoring.

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