This statement has not been evaluated by the FDA
This statement has not been evaluated by the FDA is a common disclaimer written on non-functional medication or supplements in the United States. This statement alerts the user that the FDA has only validated that the product meets the standards set for food product safety. The disclaimer is not to be confused with having no effect, as some supplements, such as vitamin D, can be harmful in excessive doses. In fact, taking unprescribed multivitamin supplements is correlated with higher mortality.[1][2]
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[edit] History
Before 1906, it was legal in most US states to claim any medicine treated any condition, and a "Caveat Emptor" marketplace was normal. The prevalence of quackery led to a popular push for more regulation. The Food and Drug Act of 1906 empowered the USDA Bureau of Chemistry (soon to be renamed the Food and Drug Administration) the legal power to scientifically verify the claims of medications.[3]. These powers extended to virtually any claim of treating illnesses.
In 1994, a new law was passed. One passed under the auspices of preventing government overreach. The Dietary Supplement Health and Education Act of 1994 allowed manufactures to claim virtually anything about "nutritional supplements" provided that 3 criteria were met:
- The supplement consisted of substances that could be found in foods.
- It didn't specifically claim to treat any illness.
- It was labeled somewhere, in tiny font, with the disclaimer "This statement has not been evaluated by the FDA."
[edit] Effects
Though not instant and dramatic, the effects of the bill have been almost entirely negative. Many pharmacies have entire aisles of useless medications with deceptive claims placed right next to medicines that went through years of research and dozens of clinical trials to be sold as safe and effective treatments. While not claiming to treat the symptoms or progression of illnesses, these products will often include vague claims like "boosting your immune system". Very little research has shown that the availability of unprescribed supplements has had any substantial benefit,[4] and they've led to a much more deceptive medical marketplace.
[edit] See also
[edit] Footnotes
- ↑ http://blogs.plos.org/publichealth/2014/08/21/multivitamin-supplements-increase-mortality-risk/
- ↑ Dietary Supplements and Mortality Rate in Older Women: The Iowa Women's Health Study by Jaakko Mursu et al. (October 10, 2011) JAMA Internal Medicine Vol 171, No. 18.
- ↑ FDA History — Part I
- ↑ It has boosted employment in Utah however: Dietary supplements become Utah’s #1 industry, topping $7.2 billion.