Archive for the ‘Dietary Supplements’ Category

While so many in the industry seem to be talking about NDI notifications as the biggest issue facing supplement companies, a recent poll of approximately 100 attendees at the recent United Natural Products Alliance (UNPA) seminar indicates that there’s another issue of more concern in the supplement industry today: GMP compliance. According to the survey results, reported in the August 15^th “Tan Sheet” (see thumbnail image), 60% of the attendees polled said that GMP compliance is currently the most important issue facing the industry – compared to only 31% of attendees who believe that NDI notification tops the list of current concerns.

Those polled aren’t the only ones noting the importance of GMP compliance on the industry; according to Daniel Fabricant, director of FDA’s Division of Dietary Supplements, “GMPS are probably the most substantial thing industry has to work on” – noting that the FDA “is seeing a pretty high rate of noncompliance.” Fabricant went on to note that “the industry should expect more GMP enforcement” – but also disconnected the two issues by saying that the agency would “likely not” enforce NDI notification through GMP inspections.

So, for now, NDI notifications and GMPs remain two separate issues – with, it appears, more in the industry possibly less concerned about NDIs than they are about GMP compliance in today’s complex supplement industry. Therefore, as GMP compliance continues to be a growing issue, ensure that your company is following all proper practices and adhering to all current and future regulatory guidelines – and, to best meet any potential expanded GMP enforcement, consider seeking professional legal counsel to help you navigate through this important time.

When clients ask me about insurance, my response is that they should not look at insurance as a separate issue but rather as part of an overall risk management program for their company.  A risk management program encompasses several things.  The idea is to minimize your company’s exposure to lawsuits, regulatory investigations and other distractions that can not only cost you time and money but, if serious enough, sink your company and everything you have worked for.

In addition to insurance, one needs to look at several factors to manage risk.  Included among those factors:

• Do your independent reps have auto insurance on their vehicles?
• Have your claims on your labels and advertising gone through legal review?
• Do you have a written AER policy and are you following it?
• Are you managing and adhering to good manufacturing practices and are you checking to make sure your manufacturers and raw material suppliers or doing so as well?
• Have you trained your customer service representatives on how to properly respond to inquiries and do you have a written policy on how to handle emergency types of calls?
• Do you know what to do when FDA shows up for an inspection at your offices?

All of these are part of your risk management program.  And questions like these are asked by insurance underwriters … how you answer them may affect your rates.
Read the rest of this entry »

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.
Read the rest of this entry »

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:
Read the rest of this entry »

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.

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.