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FDA issued a News Release yesterday stating that 4,000 pounds of raw material – Cissus quadrangularis and Cassia angustifolia extracts – found to contain “ephedrine alkaloids” were seized by U.S. Marshals. The allegation that these alkaloids were found in those raw materials is troubling and manufacturers should be on alert.

Read the full News Release below: Read the rest of this entry »

Will Congress exempt Pre-Jan. 2007 Dietary Supplements from New Dietary Ingredient (NDI) Regulations?

Rep. Dan Burton

Although we don’t yet know whether this legislation has any legs, on November 4^th Rep. Dan Burton (R-Ind.) proposed the H R 3380 – Burton, a bill that would grandfather tens of thousands of dietary supplement ingredients that have been marketed since the passage of DSHEA (October 15, 1994) up to January 1, 2007, effectively “reclassifying” their NDI status.  Recognizing that industry practices, including the cGMP’s, Adverse Event Reporting, and voluntary product auditing and testing for quality and purity, have improved dietary supplement safety for consumers, the bill highlights that fact that corresponding FDA policy remained unchanged. The bill seeks to amend section 413(d) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expand the definition of a new dietary ingredient, because the FDC Act “does not recognize the current safe market in supplements, nor how intensively supplements have been regulated over the 17 years since enactment of DSHEA to protect public health and safety, and should be updated to reflect this reality.” We will be following the progress of this legislation in hopes that it will gain momentum and support from industry, and ultimately, from Congress.

The industry breathed a temporary sigh of relief when they learned that FDA had extended the comment period for its New Dietary Ingredient (NDI) Draft Guidance by 60 days to Dec. 2, 2011. The extension came one month after five industry trade organizations requested FDA extend the comment period by 45 days. Jarrow Formulas, a dietary supplement manufacturer, had also sent a request to FDA for a 1 year extension of the comment period, so the 60 day extension is an apparent compromise by FDA. Dietary supplement manufacturers and distributors are encouraged to confer with their legal counsel and/or trade association to continue to develop and prepare comments for FDA.

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.

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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The 8th Annual International Society of Sports Nutrition (ISSN) Conference and Expo was held this past weekend in Las Vegas. Once again, the successful program included presentations from many of the brightest minds in the fields of nutrition, exercise and human performance. The Keynote Lecture was presented by one of the key historic figures in the world of sports nutrition science, Dr. Roger Harris. Both Rick Collins and Alan Feldstein attended the conference as ISSN Legal Advisors.
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Received today from MMAFacts.com:

MMA Fans,

Big, big news today.  The New York State Senate passed legislation sanctioning MMA throughout New York!

As exciting as this is, we now have to focus our efforts on the New York State Assembly.

Please take a couple minutes out of your day to call your local Assembly Member and urge him or her to pass this bill.

The bill is called A.04146 and the legislative session ends June 20th, so we have to act now to make this happen in less than 30 days!

This is a crucial moment in our campaign, and our calls will make a difference.

Great news for MMA fans who might finally get the opportunity to see MMA at MSG!

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.