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Getting tough" proposed law will benefit supplement users.
Last summer, Senator Orrin Hatch (R-Utah) and Senator Tom Harkin (D-Iowa) introduced legislation to increase funding in an effort to enable the US Food and Drug Administration (FDA) to completely implement the Dietary Supplement Health and Education Act (DSHEA), a bill they co-authored in 1994. The DSHEA Full Implementation and Enforcement Act (S. 1538) would provide the FDA with the money it needs to ensure the original law is carried out as Congress intended. It would also up the budget for the National Institutes of Health's Office of Dietary Supplements, which was treated to expand research and provide information on dietary supplements.
The FDA has often been criticized by members of Congress for inaction when it comes to enforcement of dietary supplement regulations. Passage of this legislation would take away the agency's ability to plead lack of resources when it comes to implementing law, and would, I hope, encourage the FDA to act when appropriate.
The DSHEA Full Implementation and Enforcement Act would appropriate a total of $205 million to the FDA over the next 5 years, beginning in 2004 with $20 million and increasing annually. This funding, which is specifically earmarked for implementation of DSHEA, would more than double the amount appropriated in 2003 for the same purpose. The bill also requires the FDA to submit a written report to Congress each year detailing how the agency is using its resources to regulate supplements.
We think this bill is a win for both the dietary supplement industry and consumers because it helps to eliminate the bad apples who've tarnished the industry's reputation. Part of this tarnishing comes from the controversy surrounding an herb called ephedra. This popular herb, commonly used for weight loss, is probably in the news more than it is out, and usually not in a good way. Ephedra, or mahuang as it is often called, has been continually questioned for its safety and efficacy over the past few years. As I reported 3 months ago (BN, July 2003), the FDA is weighing the evidence for and against ephedra and will issue a determination on whether or not it presents a hazard to public health.
It has become commonplace in Washington recently for lawmakers to use the ephedra controversy as a tool to begin dismantling DSHEA. In the past year, we've seen several hearings in both the House and Senate that have used ephedra as a springboard to attack this law. Rather than being treated as a unique case, ephedra is being used to raise a whole host of larger concerns about supplements--whether such concerns are justified or not.
This became crystal clear in two hearings held by a ...
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- Newspaper article from: Food Chemical News June 8, 1998 700+ words
...letter about a dietary supplement product containing ephedra, FDA noted it does...marketed as a dietary supplement, the agency...Quinn wrote FDA March 31 after...opposed by the dietary supplement industry...against it, FDA said. Currently...
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...letter, a group of dietary supplement interests asked FDA to withdraw nine...first petition asks FDA to authorize the use in dietary supplement labeling of a health...group also asked FDA to authorize use in dietary supplement labeling of a claim...
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FDA has informed a dietary supplement company that a new dietary...excluded from being a dietary supplement product. FDA said the Federal Food...information provided to FDA by Chick Cart, the dietary supplement product will contain...
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...ingredient in an FDA-approved drug could be sold as a dietary supplement product. "Pharmaceutical...DSHEA section FDA argued the lower...to mean that a dietary supplement is only prohibited...selling it as a dietary supplement, FDA argues, it would...
- FDA says new dietary ingredient is excluded from dietary supplement use.
- Newspaper article from: Food Chemical News September 6, 1999 700+ words
FDA has informed a dietary supplement company that it may not...algae was submitted to FDA May 25 by dietary supplement manufacturer Cyanotech...be safe" for use in dietary supplement products. Although FDA had raised safety concerns...
- FDA raises safety questions about new GNC dietary supplement ingredient.
- Newspaper article from: Food Chemical News October 11, 1999 700+ words
FDA has informed a dietary supplement company that it may not market a new dietary...for Ganoderma lucidum was submitted to FDA June 28 by dietary supplement company GloboAsia LLC, Hanover, Md. FDA kept the notice confidential for 90 days...
- New FDA dietary supplement rule presents challenges.(Legal Review)
- Magazine article from: Response Lustigman, Andrew Rubenstein, Sidney October 1, 2007 700+ words
...Administration (FDA) increases the...marketers of dietary supplement products on grounds...1994 (DSHEA), dietary supplement manufacturers...misleading. While the FDA has previously...action against dietary supplement products that...
- FDA raises safety questions about new dietary supplement ingredient.(Brief...
- Newspaper article from: Food Chemical News March 13, 2000 700+ words
...intended for use in dietary supplement products. FDA told dietary supplement manufacturer Lucas Meyer...introduction of the dietary supplement is prohibited from interstate commerce, FDA said. ((0FCN 0405...