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Monthly archives for March, 2011

Arnold Sports Festival 2011

Mar23rd
2011
Leave a Comment Written by Mike DiMaggio

Anold 2011For the tenth consecutive year, the lawyers of CMG traveled to Columbus, Ohio to attend the Arnold Fitness Expo, arguably the biggest annual trade show for the Sports Nutrition industry. The Expo gives us an opportunity to meet with clients, many of whom are located across the country, as well as other industry folks, and to discuss product trends, new ingredients, and matters of interest to the industry. We also show our support for the event and the sport of bodybuilding as a whole by sponsoring the Arnold Amateur Bodybuilding, Fitness, Figure, Bikini and Arm Wrestling competitions.

This year, the buzz centered around the GMPs, FDA inspections, and the controversial methylhexaneamine or 1,3-dimethylamylamine, a popular ingredient featured in a growing number of “fat loss” products marketed in the sports nutrition category. The discussion primarily focused on the legality of the substance as a dietary ingredient and recognition by many that the issue has likely garnered the attention of FDA.

Another hot topic was the NDI guidance document expected to be issued by FDA in June of this year. Whether or not the guidance document will be released on time, one thing is certain; when it is finally issued, it will have a profound effect on the marketing of New Dietary Ingredients in the sports nutrition market. Following our return, we are busier than ever, but we will continue to strive to update our blog as these matters unfold.

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Dietary Supplements, FDA, Marketing and Advertising, Regulatory, Sports Nutrition
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China to Tighten Quality Control of Raw Materials for Dietary Supplements

Mar21st
2011
Leave a Comment Written by Rick Collins

Chinese media sources (www.xinhuanet.com) report that China’s State Food and Drug Administration (SFDA) issued a circular on Friday requiring manufacturers of dietary supplements to tighten quality control over raw materials by reviewing the qualifications of raw material suppliers and inspecting the suppliers’ products regularly. The suppliers must improve the quality control of raw materials and manufacturers are directed to develop detailed records of raw material purchases to assist tracking the sources of raw materials. The SFDA also asked its local branches to more closely supervise manufacturers who use expensive and rare extractions from animals and plants and imported raw materials. The document threatened serious punishments for Chinese supplement manufacturers that use substandard raw materials. The agency pledged to both publicize and stop the distribution of unsafe supplements in China. 

Cross-contaminated raw materials from Chinese suppliers have long troubled the American supplement industry, prompting negative media reports, product recalls, and even criminal investigations. Recognition that tainted ingredients pose a serious problem is certainly a step in the right direction for Chinese authorities. Let’s hope quality control is improved not only for Chinese products, but for those raw materials that make their way across the Pacific to our shores.

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Dietary Supplements, Regulatory, Sports Nutrition, Steroids
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Leahy’s Food Bill Could Affect Supplements Too

Mar14th
2011
Leave a Comment Written by Alan Feldstein

Senator Patrick Leahy has re-introduced a bill that aims to impose strict penalties on people who knowingly distribute contaminated food.  The bill would allow prison terms of up to 10 years.  While most people will look at this bill as addressing the salmonella issue commonly associated with eggs, peanuts, and other foods often seen in the headlines, one must not forget that dietary supplements are categorized as food.  It would be a simple step to use this bill, if it passes, to prosecute those distributors of supplements who knowingly distribute products that are contaminated with illegal steroids or prescription drugs.  We will keep you advised of the bill’s progress.

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Homotaurine Gets a Red Light from FDA

Mar10th
2011
1 Comment Written by Rick Collins

A recent decision by FDA to reject a company’s citizen petition to classify homotaurine as a dietary ingredient may have far-reaching implications for the sports nutrition supplement industry.

Homotaurine was previously studied by a pharmaceutical company as an investigational new drug to treat Alzheimer’s disease. When the results proved disappointing for a viable pharmaceutical, the compound was withdrawn from clinical trials. But homotaurine showed enough promise for the company to form a subsidiary called OVOS Natural Health, Inc., which submitted a citizen petition to FDA in June 2009 requesting the promulgation of a regulation permitting the marketing of the New Dietary Ingredient (NDI) “homotaurine” for use in dietary supplements. Permission from FDA is required when a company is seeking to market a NDI that was previously investigated as a new drug. The company intended to market homotaurine not as a drug, but as a dietary supplement for memory protection. OVOS simultaneously submitted the required 75-day pre-market notification to FDA that it would be marketing the compound (under the brand name Vivimind).

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FDA Guidelines Make Supplement Execs Personally Responsible For Company Violations

Mar7th
2011
Leave a Comment Written by Alan Feldstein

FDA recently published guidelines for recommending the filing of criminal misdemeanor charges against owners and executives of supplement companies.  These are included in the agency’s regulatory procedure manual to give procedures as to when they should recommend to Federal prosecutors the filing of indictments of individuals when there is a violation of the Food, Drug & Cosmetic Act.

The agency will look at the person’s position and authority, whether the violation was obvious, the severity of the violation, whether there is a likelihood of harm to the public, as well as if there was a pattern of illegal behavior and whether or not warnings were ignored. One does not have to meet all of these criteria, but these are the factors FDA will look at to determine whether or not charges should be filed.

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