Archive for the ‘Regulatory’ Category

Alan Feldstein

Dietary supplement law expert Alan Feldstein presented at the American Herbal Products Association webinar last week to address issues surrounding the FDA’s controversial new draft guidance on NDIs (new dietary ingredients).  In his presentation, Feldstein noted that not only is there  “no logic” to FDA’s guidance regarding some of these notifications, but cautioned that this insistence would place “an impossible burden on the industry.”  Read the news story published by Nutraingredients USA on this timely and critical topic, click HERE.

To see Alan’s complete presentation, click here: Webinar Presentation 7-19-11.

Some insight and clarification offered from FDA but many questions left unanswered

The Natural Products Association hosted a Webinar featuring both an audio and video conference in the form of a slide show presentation. The Webinar featured two speakers, Dr. Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Scott Bass, head of the Global Life Sciences Team at Sidley Austin LLP, followed by a Question and Answer segment. Dr. Fabricant began by providing an overview of the document as well as FDA’s position and thought process in preparing the draft guidance. Scott Bass then briefly presented his initial impressions based on his experience with the drafting and implementation of DSHEA. He also offered his interpretation of how this document will affect industry and some feedback that he has gathered from industry.

While Dr. Fabricant did not offer much clarification with respect to many of the questions posed by Bass and the teleconference participants during the Q & A segment, he should be commended for his efforts to address the barrage the of questions he received as the representative of FDA.
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Just before the start of July 4th holiday the U.S. Food and Drug Administration released a Draft Guidance for Industry, which is entitled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. While it does not carry the authority or the enforceability of a law or regulation, it does when finalized, represent the Food and Drug Administration’s (FDA’s) current thinking on this topic of NDIs.

The FDA has asked for comments to be provided within the 90 day period that follows its issuance. We will be contacting our clients to discuss this matter with them, to assess how this Guidance will affect the products they manufacture and sell and to get their input to be included as part of a response which we will be filing. We will also assist them to prepare their own comments, which we encourage every manufacturer, distributor, retailer or supplier of dietary ingredients to submit.

There are some highlights to what FDA has put forth that you should be aware of:
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The requirement that “food facilities” register with the FDA is a provision of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act”). Dietary supplements are classified as “food” under the Food, Drug and Cosmetic Act (FDCA) as well as under Section 1.227 of the Bioterrorism Act. Therefore, dietary supplement companies that manufacture or warehouse supplement products must be registered with the FDA:

 Title 21 – Chapter 1 – Subchapter A – Part 1 – Subpart H:

 Section 1.225 Who must register under this subpart?

(a) You must register your facility under this subpart if you are the owner, operator, or agent in charge of either a domestic or foreign facility, as defined in this subpart, and your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United States, unless your facility qualifies for one of the exemptions in 1.226.

(b) If you are an owner, operator, or agent in charge of a domestic facility, you must register your facility whether or not the food from the facility enters interstate commerce.

(c) If you are the owner, operator, or agent in charge of a facility, you may authorize an individual to register your facility on your behalf.

 Section 1.227 What definitions apply to this subpart?

4) Food has the meaning given in section 201(f) of the act (21 U.S.C. 321(f)),

 (ii) Examples of food include fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods. [emphasis added]

If your facility is not yet registered with the FDA or you need to update the information on file with the FDA, visit: Registering your facility with the FDA. Collins, McDonald & Gann is also available to answer your questions about registration, in order to ensure that your company satisfies its legal obligations under federal law.

For 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.

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.

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.

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 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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Last week, Citizens for Responsibility and Ethics in Washington (CREW), a legal watchdog group, released “research demonstrating that the dietary supplement industry spent millions of dollars on well-connected lobbyists and made numerous campaign contributions to successfully thwart increased regulatory oversight of supplements.” (Read CREW’s report here)

 CREW’s press release targeted Utah Republican Sen. Orrin Hatch as being “[f]ar and away the largest recipient of campaign contributions from the supplement industry in the 2010 election cycle” for taking in the apparently whopping sum of $45,780. 

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