Posts Tagged ‘DSHEA’
FDA Rejects Senators’ Request To Withdraw NDI Draft Guidance! What’s Next For Industry … And What Can We Do?
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request of Senators Orrin Hatch and Tom Harkin asking the FDA to immediately withdraw the New Dietary Ingredients (NDI) Draft Guidance.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 According to the Senators, the current Draft Guidance “serves to undermine DSHEA in a number of important aspects” and did not meet their intent when they wrote the law.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meeting with the FDA back in December to discuss the issue in the hopes that FDA would withdraw the controversial Draft Guidance and replace it with a new one that was consistent with the law and their intent.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 Hatch and Harkin’s request to withdraw the controversial Draft Guidance, therefore, was denied – leaving many in the industry to wonder where we go from here. The FDA clearly seems to be committed to moving forward and using the NDI Draft Guidance process to inch things ever closer to a system approximating premarket approval (which was never the intent and was specifically excluded by DSHEA).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 »
Senators Urge FDA to Withdraw NDI Draft Guidance: Encouraging News for the Supplement Industry
In what may be considered highly encouraging and promising news for the supplement industry, Senators Orrin Hatch (R-UT) and Tom Harkin (D-Iowa) have asked FDA Commissioner Dr. Margaret Hamburg to withdraw the controversial NDI Draft Guidance — and replace it with a new draft that, according to the Senators, “will provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products.”
As reported in yesterday’s American Herbal Products Association Update, Senators Hatch and Harkin — who were the principal authors of the Dietary Supplement Health and Education Act (DSHEA) and are in a unique position to comment on this controversial new draft guidance and whether it is consistent with DSHEA — wrote a letter to the FDA to formally ask them to withdraw the document. In their letter, the Senators pointed out that the draft guidance “serves to undermine DSHEA in a number of important aspects” — and went on to note their many concerns with the draft guidance (which many experts in the supplement industry have been noting since this controversial draft guidance for NDIs was introduced.) Read the rest of this entry »
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 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.
