Posts Tagged ‘FDA’

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.

June 25, 2010 –  Today marks the date by which small businesses, meaning dietary supplement manufacturers with less than 20 employees, must be compliant with the current Good Manufacturing Practices (cGMPs) for dietary and nutritional supplements. It has been nearly 16 years since the Dietary Supplement Health and Education Act (DSHEA) was passed. DSHEA contained a provision requiring that FDA establish and enforce cGMPs, and while drafts were presented for comment over the years, it was not until 2007 that the cGMPs were finally approved, along with a three phase process for enactment, the final phase taking effect today. Read the rest of this entry »

Making claims that a dietary supplement product can treat, cure or prevent a disease; making claims that are not substantiated or even worse, claiming that clinical studies have been performed when in fact, they have not, can result in substantial forfeiture of assets and federal criminal charges. The supplement industry is familiar with FDA and FTC oversight of dietary supplement claims resulting in consent decrees and civil penalties for violations of federal regulations. But what companies are not as familiar with are FDA’s enforcement powers to launch criminal investigations which are prosecuted by the United States Attorney’s office. Below is a recent example of the kinds of penalties that not only companies but individuals can be subject to for making false claims about supplement products. CMG works with our clients to review their label and advertising claims for compliance with federal laws and regulations, to help prevent or avoid this kind of situation from occurring:

Read the rest of this entry »

Recently Rick Collins and Alan Feldstein gave a speech at the ISSN conference in New Orleans on the effect the new Administration will have on our industry. They spoke about their belief that there will be greater regulatory scrutiny and more enforcement of dietary supplements, especially in the sports nutrition category.They emphasized the need to strictly comply with the law and to make sure that all dietary supplement products are substantiated, manufactured and marketed appropriately, and in fact actually fall within the definitional requirements for dietary supplement products as enunciated in DSHEA.

Those thoughts and opinions have now been echoed Margaret Hamburg, M.D., the newly appointed FDA Commissioner, during a recent speech at an industry sponsored conference.

Read the rest of this entry »

The General Accountability Office (GAO) recently released a report to Congressional requesters on the issue of whether “FDA should take further actions to improve oversight and consumer understanding” of dietary supplements. In recommending that the Secretary of Health and Human Services direct the FDA Commissioner to request additional authority to oversee dietary supplements, one of the key areas of GAO focus was adverse event reporting.The report recommends requiring that all supplement adverse events be reported, not just serious ones, and that supplement companies register annually as such and maintain records of their products and labels.

Read the rest of this entry »