Archive for the ‘FDA’ Category

Just before the start of July 4th holiday the U.S. Food and Drug Administration released a Draft Guidance for Industry, which is entitled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.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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Bradford W. Williams

May 2^nd to 4^th 2011 – Once again, SupplySide_® East, held at the Meadowlands Exposition Center in Secaucus, New Jersey, played host to thousands of folks involved in the food, beverage, cosmetic, personal care and dietary supplement industries. In addition to the nearly 300 exhibitor booths, SupplySide_® East also featured a variety of Speakers presenting on topics of interest to members of industry. Bradford W. Williams – presently the manager for the Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (CFSAN), of the Food and Drug Administration (FDA) – focused much of his presentation on GMP Compliance and FDA’s inspection priorities as well as the major findings from the last 18 months of inspections.

According to Williams, FDA’s GMP inspection priority begins with manufacturers that blend and fabricate products, followed by companies that package and label finished products, and then entities that merely attach the product label. He indicated that FDA’s major findings included the following violations:

• Inadequate or failure to conduct identity testing
• Failure to establish specifications for components, ingredients, steps and stages of manufacturing and finished products
• Failure to conduct testing to ensure product meets specifications
• Failure to maintain adequate master manufacturing records (MMR) and Batch product records (BPR) content and recordkeeping requirements
• Failure to conduct material reviews
• Lack of adequate corrective action plans (CAP)

Williams indicated that after reviewing the 2010 FDA GMP inspections, the violation rate is estimated to be nearly 25%. Unfortunately, this is an indication that the industry is having a difficult time coming into compliance. If you have questions about the GMPs or need guidance on compliance measures, please call our office at (516) 294-0300.

On Wednesday, May 4th Mike DiMaggio will be attending Supply Side East on behalf of Collins, McDonald & Gann. Supply Side East is an important trade show for cosmeceutical, food, beverage and supplement product developers, marketers and formulators. It offers the opportunity to meet hundreds of exhibitors offering thousands of innovative and healthy ingredients! In addition to meeting with clients and colleagues, Mike will be walking the floor of the Expo and attending several of the seminars. Of particular interest are the seminars hosted by Vasilios Frankos, Ph.D., who recently retired from the U.S. Food and Drug Administration where he served as the director, division of dietary supplements programs, Center for Food Safety and Applied Nutrition (CFSAN). Dr. Frankos was the lead scientist for dietary supplements for the FDA and was responsible for the full implementation of the DSHEA Act of 1994. He directed and coordinated policy and administrative activities within the division, and advised on policy and management issues on dietary supplement programs, new dietary ingredient safety assessments, good manufacturing practice, adverse reaction monitoring and related activities pertaining to dietary supplements. Dr. Frankos is currently the senior vice president for global product science, safety and compliance, Herbalife Intl., and now that he has had a chance to experience the life of the regulated rather than the regulator, in his presentation he will share his thoughts and observations on the regulatory/scientific state of the dietary supplement industry from both sides of the fence, aptly titled, An FDA Insider’s View of the Dietary Supplement Industry from the Other Side of the Fence.

Also of particular interest will be the presentation of Featured Speaker Bradford W. Williams, who is the current manager of the division of dietary supplement programs for FDA. His presentation is entitled, FDA Update on GMP Inspections and DSHEA, in which he will be sharing the agency’s observations from GMP inspections and will talk about how industry is doing now that compliance is required and what areas are of the most concern to the FDA.

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.

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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While it is more common to read about fines, consent decrees, and recalls, if you make unlawful claims and engage in other illegal activity you may be prosecuted criminally. Recently, two marketers of dietary supplements received prison sentences in addition to the 11.9 million dollar judgment that was levied against them, for making illegal claims that the products they sold could prevent, treat or cure various diseases. Tony Pham, who operated Techmedica Health Inc, and Charles Thao of Nutrapha Research LLC pleaded guilty to conspiring to violate the Food, Drug and Cosmetic Act and to commit wire fraud, mail fraud, and money laundering. Additionally, both men are accused of using computer technology to hide their illegal websites by using “mirror image technology” to cause alternative websites with “sanitized” claims to be displayed whenever they were visited by someone with an FDA ISP address. While clever, the only people they’ll be able to brag to now will be their fellow inmates. Pham will serve three years in prison without parole and Thao was sentenced to eight years and one month without parole.

For additional information on this story, click the link below: http://www.fda.gov/ICECI/CriminalInvestigations/ucm234904.htm

On Tuesday, January 4^th 2011 President Obama signed the FDA Food Safety Modernization Act into law. This is the first major food oversight reform for FDA since 1938. The law will give FDA mandatory recall authority and will allow for greater access to the records of companies whose products are deemed at high risk for causing potential adverse events. Additionally, FDA plans to step up the frequency of facility inspections, bringing the minimum up to once every 5-7 years instead of the previously mandated 8-10. Imported products will also face greater scrutiny, as the new law will require safety certification and supplier verification for all foodstuffs brought into the US. With some limited exceptions, the new legislation covers all food products, including dietary supplements. Supplement manufacturers and importers should consult with qualified legal counsel to fully understand how this will affect their business. 

The legislation does not, however, include any significant increase in FDA’s budget, leaving many wondering how the agency will fund the new procedures it hopes to put into effect. Several members of the now Republican controlled House of Representatives have stated that they do not believe the overhaul is necessary and that they will not support the additional funding needed to make many of the new enforcement measures a reality. Nevertheless, FDA Commissioner Margaret Hamburg remains optimistic; she has publicly stated that she believes FDA will be able to work with Congress to find the funding needed to realize the new law’s food safety objectives.

In late November it was announced that the head of FDA’s Office of Criminal Investigations (OCI), Terry Vermillion, would be resigning in December after leading the unit for almost two decades. Vermillion, who spent twenty years in the Secret Service prior to joining FDA, has faced criticism in the last several years from House and Senate Republicans who questioned OCI’s prioritizing of drug-abuse cases, generally agreed to be the jurisdiction of DEA, over broader violations by large companies. Read the rest of this entry »