HEALTH

FDA fortifies VMS oversight with revised draft guidance on NDIs

BY Michael Johnsen

SILVER SPRING, Md. – In the latest move to fortify regulations governing the dietary supplement industry, the U.S. Food and Drug Administration on Thursday issued a revised draft guidance to improve dietary supplement companies' new dietary ingredient premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.

In response to the news, the Council for Responsible Nutrition joined Informa Exhibitions with plans for an industry-wide webinar on the topic of New Dietary Ingredient Notifications.

“This is a topic that we’ve been actively involved in for several years now, and with the release of the new draft guidance, companies have questions and we’re poised to provide the right experts with answers,” noted Duffy MacKay, SVP scientific and regulatory affairs, CRN. “We’re taking the time to review the substance of the draft guidance in order to bring [the industry] the most qualified regulatory experts, and we expect the experts to include representatives from FDA.”  

MacKay added that the webinar will take place in September and the specifics (including date, speakers and pricing) will be announced soon.

"This revised draft guidance is an important step forward in the agency's work to protect public health from potentially dangerous new dietary ingredients," stated Steven Tave, acting director of the FDA's Office of Dietary Supplement Programs. "Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers. The revised draft guidance is intended to improve the quality of industry's new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements."

Under the Dietary Supplement Health and Education Act, the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient (one that was not marketed in the United States before Oct. 15, 1994), unless the NDI is used in the food supply without chemical alteration. Dietary supplements are considered adulterated if they contain an NDI not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.

The FDA estimates that there are more than 55,600 dietary supplements on the market, and that more than 5,000 new dietary supplement products come on the market each year. However, the agency has received fewer than 1,000 NDI notifications in the more than 20 years since DSHEA was passed.

An initial draft guidance, "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," was released in 2011. After considering the feedback received on that draft, the FDA revised the draft guidance to clarify several important points that were misunderstood or not fully explained, to describe the public health significance of the recommendations and to request additional comment before publishing a final guidance.

Over the past three years, the FDA has taken numerous actions on dietary supplements, including action on several products containing new dietary ingredients that pose safety concerns and should have been the subject of an NDI notification but were not, such as Acacia rigidula.

In December 2015, the agency announced the creation of the Office of Dietary Supplement Programs, elevating the program from its previous status as a division under the former Office of Nutrition, Labeling and Dietary Supplements (now Office of Nutrition and Food Labeling). As part of that action, the agency reaffirmed its commitment to remove from the market products that contain potentially harmful pharmaceutical agents, are otherwise dangerous to consumers, or are falsely labeled as dietary supplements; enforce the dietary supplement good manufacturing practices regulation; and take action against claims that present a risk of harm to consumers (such as egregious claims of benefit in treating serious diseases) or economic fraud.
 

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The Female Health Company and Aspen Park Pharmaceuticals names board of combined company

BY Michael Johnsen

CHICAGO  – The Female Health Company and Aspen Park Pharmaceuticals on Thursday named the members of the new board of directors of the combined company who will begin serving upon completion of their proposed merger.
“The Veru Healthcare Board includes some of the most highly regarded and renowned individuals in their respective fields,” stated O.B. Parrish, chairman and CEO FHC.

“This board brings the right blend of commercial, medical, pharmaceutical and financial expertise and experience to help guide management in the operation of Veru Healthcare, a diversified pharmaceutical and consumer health men’s and women’s health and oncology company,” added Elgar Peerschke APP board member and chairman of the new board.

“Since the transaction was announced in April, the management teams of both companies have been working closely to ensure a seamless integration. As part of that effort, we formed a transition team that is focusing considerable attention on advancing APP’s product pipeline and further developing the strategic plan to expand the commercial markets for FC2 in the U.S. and internationally,” noted Mitchell Steiner, CEO APP and Veru Healthcare.

The board of the combined company, to be called Veru Healthcare, will be comprised of nine members, with three directors named by FHC (Parrish, David Bethune and Mary Margaret Frank), three directors currently on APP’s Board of Directors (Steiner, Harry Fisch and Peerschke) and three new directors (Georges Makhoul, Lucy Lu and Mario Eisenberger).

Veru Healthcare's board of directors:

  • Elgar Peerschke, chairman. Peerschke is president advisory services at Quintiles Transnational Holdings and was previously senior partner in the Global Health Care Practice of Bain and Company;
  • Mitchell Steiner, vice chairman, CEO and president. Steiner is co-founder, CEO and president of APP, and was previously president, urology of OPKO Health. Steiner is a board certified urologist and was professor and chairman of urology, University of Tennessee;
  • David Bethune, director. Bethune has served as a Director of FHC since 1996 and was previously chairman and CEO of Zila. He has served as founding trustee of the American Cancer Society Foundation and founding chairman of the Corporate Council of the New York City Children’s Health Fund;
  • Mario Eisenberger, director. Eisenberger is professor of oncology at Johns Hopkins University, and was previously head of Advanced Prostate Cancer Committee of Southwest Oncology Group. Eisenberger has served on advisory boards for Bristol Myers Squibb, Sanofi, Jansen, Ipsen, Medivation, Astellas, Ortho Biotech, Bayer and others and as an Ad Hoc member of the Oncologic Drugs Advisory Committee of the FDA. He is a founder of Oncology Insights, aclinical trials contract research organization;
  • Harry Fisch, director and COO. Fisch is a co-founder and chairman of APP, and was previously clinical professor of urology and reproductive medicine at Cornell University. He is a board certified urologist and author;
  • Mary Margaret Frank, director. Frank has served as a director of FHC since 2004 and is associate professor of accounting at the Darden Graduate School of Business at the University of Virginia and Academic Director for Darden’s Initiative for Business in Society and was previously assistant professor at the University of Chicago Booth School of Business. She has a master’s degree and Ph.D. in accounting from the University of North Carolina at Chapel Hill, and has been a CPA since 1994;
  • Lucy Lu, director. Lu is Interim president and CEO of Avenue Therapeutics and EVP and CFO of Fortress Biotech, and was previously senior biotechnology equity analyst with Citigroup Investment Research and Principal of First Albany Capital;
  • Georges Makhoul, director. Makhoul is CEO of Constellation Holdings and was previously president of Morgan Stanley Investment Banking Europe, Middle East and North Africa; and led National Science Foundation Research Center at Columbia University; and
  • O.B. Parrish, director. Parrish is co-founder, chairman and CEO of The Female Health Company and was previously president of Searle's Global Pharmaceutical Group and EVP of Pfizer International division.
     

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Performance Health launches Biofreeze into retail from professional market

BY Michael Johnsen

AKRON, Ohio – Performance Health recently announced the availability of Biofreeze at consumer retail starting in the fall of 2016.

For 25 years, in concert with healthcare professionals, Biofreeze Pain Reliever has been helping people reduce their pain. Now the brand will also reach consumers who purchase pain relief products at retail, including grocery, drug and mass merchandise stores, expanding the reach of the pain relief that Biofreeze and its healthcare professional partners provide.

“Pain is a limiting factor in many people’s lives. When you are in pain and missing the best parts of life, you appreciate finding a new product or a new expert to help you get back to it," stated Ethan Pochman, VP global marketing Performance Health. "Our expansion into retail will expose more people to the power of both Biofreeze and our partners, this country’s talented pain relief professionals,” he said. “The success of Biofreeze and its army of supporters rally around one simple fact: it’s proven to work. In addition to being the No. 1 recommended brand of pain relief professionals, Biofreeze is also the No. 1 topical pain reliever recommended by retail pharmacists, and the topical pain relief brand most searched for on the Internet. That speaks to 25 years of pain relief that really works.”

Biofreeze Pain Reliever is a safe and effective pain relief alternative because it is non-systemic, non-narcotic and contains no NSAIDs, salicylates or addictive substances. It does not require a prescription, contains United States Pharmacopeia grade menthol to provide fast acting pain relief and is free of parabens and propylene glycol.

Biofreeze is available in both its signature green and colorless (dye-free) formats, is never tested on animals and is produced in the United States.

 

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