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Many Manufacturing Problems Showing Up in Dietary Supplement Industry

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The U.S. Food and Drug Administration (FDA) has identified violations of manufacturing rules in approximately 450 of the dietary supplement firms it has inspected during the past four years. Following the publication of a Final Rule that governed the manufacturing, packing and holding of dietary supplements in 2007, FDA began inspecting dietary supplement facilities to assess their degree of compliance with the new rule. Inspection reports over the past 4 years indicate the dietary supplement industry is barely able to meet basic manufacturing standards, including verifying ingredient components of its products and executing normal quality control procedures for finished products (dietary supplements), according to a recent Chicago Tribune article by Trine Tsouderos.

Tsouderos noted a disturbing fact that “some firms don’t even have recipes” for their products.[1] During the inspections, the reports also noted, FDA found some supplement factories to be unsanitary. A New Jersey laboratory producing protein powder, as well as supplements, was found to be “infested with rodents, rodent feces and urine.”[2] Daniel Fabricant, head of FDA’s Division of Dietary Supplement Programs, believes the situation is “scary”, as one in four dietary supplement companies inspected by the agency has received a warning letter from the FDA.[3] In this year alone, in 204 FDA inspections conducted of approximately 200 supplement firms’ facilities, 70 received serious warnings.

Spokespersons for more than one trade association that support the dietary supplement industry, such as the American Herbal Products Association and the Natural Products Association, say the industry is trying to do better and the “inspection numbers are unfortunate.”[4] They should tell that to the more than 200 victims of one dietary supplement that contained a greater than safe amount of selenium which made trusting consumers seriously ill, and in some people, sustained lasting negative effects.[5]

The bottom line is caveat emptor or buyer beware when it comes to purchasing many dietary supplements. The supplement manufacturers are not regulated as the pharmaceutical companies are, and we still have problems with the latter, so one can only imagine what kind of problems, short-cuts, inferior ingredients, or downright fraud there is involved in the manufacture of many supplements. That being said, there many legitimate and safe supplements on the market, but determining which are safe can be the difficulty.


[1] “Dietary Supplements: Manufacturing Troubles Widespread, FDA Inspections Show”, Tsouderos, Trine, The Chicago Tribune, June 30, 2012, Chicago, Illinois. http://articles.chicagotribune.com/2012-06-30/news/ct-met-supplement-inspections-20120630_1_dietary-s

[2] Op. Cit.

[3] Ibid.

[4] Ibid.

[5] Ibid.

2 Comments

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  1. Clinton Blumer says:
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    Why is this witch hunt only directed towards the dietary supplement industry and not the pharmaceutical industry? Guess!

  2. Clinton Blumer says:
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    Why is this witch hunt only directed towards the dietary supplement industry and not the pharmaceutical industry? Guess!