WASHINGTON, DC--When the Food and Drug Administration, which regulates dietary supplements, recently requested emergency funding to conduct a study of consumer perceptions and attitudes about dietary supplement labels, the consumer advocacy group Citizens For Health took exception.
Citizens For Health has filed comments with the U.S. government recommending that the request be denied, and that the FDA instead focus on implementing the law under which supplements are regulated, which it has not done.
The comments were prepared for Citizens For Heath on a pro bono basis by the New York city law firm Ullman, Shapiro & Ullman.
Citizens For Health stated that until the FDA provides a full explanation of its failure to attend to serious matters remaining to be completed under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the law under which dietary supplements are regulated, an emergency request for funding surveys is "inexplicable." Though DSHEA was signed into law in 1994, the FDA still has not produced Good Manufacturing Practices (GMPs ) for dietary supplements as specified by the law. The supplements industry has repeatedly asked the FDA to institute GMPs as mandated by law, only to be met with delays and excuses.
"We would absolutely support emergency funding in order for the FDA to comply with the law by establishing GMPs. We also support the agency revamping the Adverse Event Reporting systems, which are currently a disaster, so that when questions are raised about dietary supplements, or other FDA regulated products, there is an accurate system in place for evaluating the situation in a rational, unbiased, scientific manner." said Citizens For Health Board Chair Jim Turner.
"Many of the questions that consumers are asking about the safety of dietary supplements, stem from FDA's failure to accept its responsibility to fully regulate the industry as they are empowered to do under the law, and its failure to communicate that oversight to consumers. If the FDA truly feels it needs information on consumer perceptions, it can get it from the dietary supplements industry, which has data on consumer perception and a track record of cooperating with the FDA." Turner said.
"The consumers we represent sent Congress more than 1,000,000 letters in 1994 demanding that they have access to dietary supplements and information regarding their use, safety and efficacy", said Turner. "We trust the FDA will not require these same MILLION consumers to speak out again in order to see the law fully implemented."
Marc Ullman, author of the comments, said "for FDA to seek to spend consumer tax dollars on a project like this at a time when it has failed to comply with the letter or spirit of DSHEA is preposterous. By continuing this type of inexcusable behavior, FDA is failing to protect the interests of both the consumer and the regulated industry. The time for FDA to stop its irrational efforts to undo DSHEA has long since past. The Agency should move on, and serve the public interest by complying with its congressional mandate and implementing the law as written."
Citizens For Health is a nonprofit, grassroots, consumer advocacy group that champions public policies empowering individuals to make informed health choices. Citizens For Health has played important roles in the formulation and passage of DSHEA, medical freedom legislation in nine states, organic regulation, and licensing of alternative medicine practitioners.
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