201309.26
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FDA Cracks Down as Industry Continues to Struggle with Ingredient Specifications

Under the 2007 supplement Good Manufacturing Practices (“GMP”) final rule, as well as the pending Food Safety Modernization Act regulations, supplement companies must set out specifications to identify an ingredient’s source and lifecycle.  Industry has struggled to comply with the GMPs in this area.  Since April 15, 2013, FDA has issued at least six Warning Letters…

201308.20
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THE LATEST COVER STORY ON SUPPLEMENTS: The Industry Braces Itself as FDA Claims Consumers are “Put at Risk by Supplement Companies’ Manufacturing Woes”

Today’s Newsday features a negative cover story on the supplement industry – noting that a top FDA official has claimed that “about 70 percent of the nation’s supplement companies have run afoul of the US Food and Drug Administration’s manufacturing regulations over the past five years.” With its attention-grabbing headlines stating “Buyer Beware” and “The…

201308.01
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Sen. Durbin Likely to Reintroduce the Dietary Supplement Labeling Act

Dietary supplement regulations have been a hot topic on Capitol Hill lately.  Earlier this week, Sen. Dick Durbin, D-Ill., announced that he will reintroduce the Dietary Supplement Labeling Act along with Sen. Richard Blumenthal, D-Conn. According to the Natural Products Association, “Sen. Durbin explained that this legislation will require more information on dietary supplement labels….

201307.18
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Update on Revised NDI Guidance

It remains unclear when FDA will issue its revised NDI guidance, but industry groups and members of Congress continue to put pressure on the agency to take action. “In a July 9 letter to Commissioner Margaret Hamburg, 18 House members said they ‘encourage the agency to continue its efforts to bring clarity to’ NDIs.”  This…

201303.28
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Debate and Legislation Surrounding Energy Drinks Ensues

Energy drinks continue to make national and local headlines as manufacturers change marketing the products from dietary supplements to beverages and local governments pass new regulations. After 10 years of marketing their energy drinks as dietary supplements, Monster Beverage changed the marketing of its energy drinks from dietary supplements to beverages earlier this month.  In…

201302.01
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State Lawmakers Look to Ban DMAA

In 2012, FDA warned numerous companies that synthetic DMAA (1,3-dimethylamylamine) is not a dietary ingredient, and now state lawmakers have submitted proposals to regulate the ingredient at the state level.  For example, on January 17, 2013, New York State Senate Co-Leader Sen. Jeff Klein submitted legislation to ban sales of products containing DMAA in New…

201301.15
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The Need for Truthful Reporting in the Dietary Supplement Industry

On January 8, 2013 the Journal of the American Medical Association (JAMA) reversed a statement it previously made in a December 19, 2012 article regarding the adverse effects of energy drinks.   In the December article, JAMA misrepresented FDA’s regulatory control over the energy drink market by claiming that FDA does not regulate energy drinks.  JAMA…