Virginia (202) 466-6937 | Arizona (602) 388-8899

FDA’s Unbridled Discretion Over Supplement Adulteration

If you ask a consumer what makes a dietary supplement adulterated, he or she will say that it contains an ingredient or contaminant that makes it unfit for human consumption.  That is, of course, the logical and historically plain meaning of the term adulteration, but that is not the meaning of adulteration FDA gives to […]

FDA’s Evisceration of the Labeling Exemption in 21 USC 343-2

The FDA has rendered the labeling exemption in 21 USC 343-2 a dead letter through construction.  That provision of the Dietary Supplement Health and Education Act was inartfully written but nevertheless designed by Congress to liberate dietary supplement companies from the prohibition on nutrient-disease claims in 21 USC 343 when they supplied independent scientific literature […]

FDA Tightens the Screws

Years ago when lawyers in the dietary supplement industry first began to clamor for the adoption of regulations to impose good manufacturing practice guidelines on the industry, I warned that this move would provide an FDA intent on destroying that industry the best means to achieve that objective.  For decades the FDA through Republican and […]

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Telephone: (202) 466-6937
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Gilbert, AZ 85295
Telephone: (602) 388-8899
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