Posts Tagged ‘FDA’

Last week, in a move that has shocked many in the supplement industry, the FDA rejected the request of Senators Orrin Hatch and Tom Harkin asking the FDA to immediately withdraw the New Dietary Ingredients (NDI) Draft Guidance.  This move was more than surprising to many in the industry – especially considering that the Senators were the authors of the Dietary Supplement Health and Education Act (DSHEA)!  According to the Senators, the current Draft Guidance “serves to undermine DSHEA in a number of important aspects” and did not meet their intent when they wrote the law. The Senators had requested an in-person meeting with the FDA back in December to discuss the issue in the hopes that FDA would withdraw the controversial Draft Guidance and replace it with a new one that was consistent with the law and their intent.

The meeting between FDA‘s Dr. Daniel Fabricant and Sens. Hatch and Harkin ended with the FDA, as noted by some in the industry, “sticking to its guns on its interpretation of what the NDI section of DSHEA means, regardless of what the senators say they meant when they wrote the law.”  Sens. Hatch and Harkin’s request to withdraw the controversial Draft Guidance, therefore, was denied – leaving many in the industry to wonder where we go from here.  The FDA clearly seems to be committed to moving forward and using the NDI Draft Guidance process to inch things ever closer to a system approximating premarket approval (which was never the intent and was specifically excluded by DSHEA). Read the rest of this entry »

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.

On September 8th, the American Herbal Products Association (AHPA) held a one-day intensive event to help herbal and dietary supplement companies “sift through the clutter, the hype and unanswered questions” when it comes to NDI notifications. The event, the AHPA NDI Congress: Crafting an Industry Response and Filing Successful Notifications, took place in downtown Chicago, with CMG’s Alan Feldstein serving as a speaker at this high-profile, interactive industry gathering.

The event was designed to help herbal and dietary supplement companies take the next step in responding to the FDA’s draft guidance on NDIs and to develop and submit NDI notifications for numerous product categories.  According to the Tan Sheet’s coverage of the event, AHPA President Michael McGuffin stated that he is confident FDA will ultimately require notifications strictly for new dietary ingredients, and not all supplements containing those ingredients. McGuffin went on to state that “There is no way that enforceable, final guidance requires every downstream finished product to file an NDI notification or be subject to enforcement action” — adding that “We will build not only opinions but also a strong legal argument as to why that’s inaccurate.” Read the rest of this entry »

This Saturday, September 17^th, 2011, at the Las Vegas Convention Center Expo, Room S219, the attorneys of CMG will be speaking as part of the International Society of Sports Nutrition’s (ISSN) Europa University.

From 2:00pm-3:00pm PST – Rick Collins, Esq., FISSN, joined by Alan Feldstein, Esq. and Michael DiMaggio, Esq. will be conducting a presentation entitled: FDA Draft Guidance on New Dietary Ingredient Notifications: Is it a “Game Changer” for the Sports Nutrition Industry?

The presentation will include issues such as:

• How FDA’s most recent guidance will affect innovation in the sports nutrition industry.

• The Nuts and Bolts of NDI Notifications: requirements, process and exemptions.

• What industry and consumers should know about supplement Safety Data and studies?

Please join ISSN and the attorneys of CMG this Saturday for this important presentation.

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.

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 »

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.