Author Archive
McCain’s Proposed Bill & the Sports Nutrition Industry
John McCain (R-Ariz.) announced in a press conference that he intends to introduce new legislation which would effectively amend the Food, Drug & Cosmetic Act, particularly with respect to DSHEA. Click here to see the full text of proposed legislation.
We intend to further analyze this legislation; however, our initial impression is that we cannot see this bill passing without substantial modifications. Here are the highlights. The amendments proposed in McCain’s legislation could certainly be interpreted as throwing out the idea of “grandfathered” ingredients in favor of a list of “acceptable dietary ingredients” which would seem to suggest that FDA will be quite busy assessing all of the dietary ingredients marketed in the United States in order to determine whether they are “reasonably expected to be safe.” Either that or they are going to start from scratch and require every company to just begin filing these notification packets for every single dietary ingredient they currently sell…that shouldn’t take too long for FDA to review. Obviously this issue would require substantial clarification as the legislation retains the term “New Dietary Ingredient” but seems to remove the old section about ingredients marketed prior to 1994, which is what establishes the basis for the “old” or “grandfathered” dietary ingredients.
FDA Commissioner Hamburg’s Speech and the Potential Impact on the Supplement Industry
Recently Rick Collins and Alan Feldstein gave a speech at the ISSN conference in New Orleans on the effect the new Administration will have on our industry. They spoke about their belief that there will be greater regulatory scrutiny and more enforcement of dietary supplements, especially in the sports nutrition category.They emphasized the need to strictly comply with the law and to make sure that all dietary supplement products are substantiated, manufactured and marketed appropriately, and in fact actually fall within the definitional requirements for dietary supplement products as enunciated in DSHEA.
Those thoughts and opinions have now been echoed Margaret Hamburg, M.D., the newly appointed FDA Commissioner, during a recent speech at an industry sponsored conference.
New Report… CBS NEWS: “The ‘Legal’ Steroid Danger”
Sports nutrition supplements are back in the news and once again it’s not a positive story. Today CBS News ran a story entitled, “The ‘Legal’ Steroid Danger,” which featured several dietary supplement products that contain the substance 19-Norandrosta 4,9 diene- 3,17 dione (also known as Estra-4,9-dien-3,17-dione), which is purportedly a progestin similar to trenbolone, nandrolone and methyltrienolone.
New GAO Report May Bring Heightened Oversight of Supplements
The General Accountability Office (GAO) recently released a report to Congressional requesters on the issue of whether “FDA should take further actions to improve oversight and consumer understanding” of dietary supplements. In recommending that the Secretary of Health and Human Services direct the FDA Commissioner to request additional authority to oversee dietary supplements, one of the key areas of GAO focus was adverse event reporting.The report recommends requiring that all supplement adverse events be reported, not just serious ones, and that supplement companies register annually as such and maintain records of their products and labels.
Welcome to the Supplement Counsel Blog of CMG!
The lawyers and support team of Collins, McDonald & Gann are proud to announce a new resource for the dietary supplement and sports nutrition products community. We’ll be keeping industry informed about legal developments and news on a regular basis. This weekend, like many in the sports nutrition industry, we’re off to the Arnold Sports Festival and Fitness Expo in Columbus, Ohio. Alan Feldstein, Esq. from Los Angeles, and Mike DiMaggio, Esq. and Rick Collins, Esq., from New York will be meeting with clients throughout the weekend. We look forward to seeing you here when we return!
