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FDA Oversight of Dietary Supplement Industry Expanding?

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The makers of dietary supplements—vitamins, minerals and botanicals– and sellers of “novel” products such as minerals, plants and amino acids, are drawing lines in the sand, as the FDA’s power appears to be growing and pushing into their territories, according to The Los Angeles Times article of January 26, by Melissa Healy. It seems the FDA is now paying attention to the multitude of products classified as “dietary supplements” which are flooding the market, especially those it suspects may not be as safe as consumers may believe.

Last July, the FDA laid down a new set of rules for those marketing "novel" dietary supplements in the U.S. These rules denote how to establish a "reasonable expectation of safety” of these products. In some cases, the FDA could accept supporting documentation of a supplement's use in other countries, or it could request to examine proof of safety gained from animal studies or other scientific experimentation. Human trials of a dietary supplement are permitted to help establish the supplement’s safety for its long-term use, but they are presently not required.

The dietary supplement industry spends a lot of money annually developing, advertising and selling its formulations. These companies may push back now that the FDA is establishing some guidelines, especially if the products have already been developed and sold in other countries.

Since 1994, the FDA has required the dietary supplements industry and those who sell their products to provide federal regulators with substantiation of a product's "reasonable expectation of safety." But the manufacturers are “under no obligation to share unfavorable safety data on a product with the FDA, so long as they offer studies that show the product is safe.” [1][1]

But the medical community doesn’t think the FDA has gone, or is going, far enough and is beginning to voice its concern about the FDA’s lack of scrutiny into supplements thus far. Dr. Pieter Cohen, a Harvard University Assistant Professor of Medicine, stated that “Even the vague [1994] standard has gone unenforced by the FDA and likely ignored by manufacturers eager to bring their supplements to market.”[2][2 Hopefully, a tragedy impacting many people will not be necessary in order to prompt effective oversight of the supplement industry.


[1][1] “Dietary Supplements Safety Regulation: Too much or not enough?”, Healy, Melissa, The Los Angeles Times, January 26, 2012. http://www.latimes.com/health/boostershots/la-heb-dietary-supplements-safety-20120126,0,423168.story?track=rss

[2][2] Op. Cit.