The Alliance For Natural Health

Is the FDA Planning an Unpleasant Surprise?

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fdaWe know that the FDA is discussing new regulatory requirements for supplements.

The Agency has not only discussed this internally. It has also sent out some feelers to see if some support can be generated within the natural products community. Reaching out in this way is often a rewarding strategy for the Agency. The reason is that some major companies actually favor more regulation because it discourages competition from small or new companies. This is another example of the crony capitalism that is so prevalent in the government/industry medical complex.

We have it on good authority that FDA Commissioner Joshua Sharfstein believes he has the regulatory authority to implement additional requirements for supplements without legislation. What might the new regulation look like? Possibly pre-registration, where any supplement must be registered with the FDA. Possibly pre-approval, which the FDA could refuse to grant on any number of grounds. More likely: pre-registration leading in a short time to pre-approval.

With respect to pre-approval, keep in mind that the Agency tends to believe that no supplement is safe, no matter how much science or longstanding dietary use is cited, unless the producer pays up to a billion dollars to take the substance through the full FDA drug approval process. This is why ANH-USA has (successfully) sued to make the Agency allow some partial health claims on supplement products.

ANH-USA is opposed to any such new measures, which are unnecessary, burdensome, and would result in reduced access to supplements. Supplements are more than adequately regulated. Supplements are also already required to register with the FDA under “The Public Health Security and Bioterrorism Preparedness and Response Act of 2002”.  (http://www.nutritionaloutlook.com/article/public-health-security-and-bioterrorism-preparedness-and-response-act-2002; http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081616.htm)

ANH-USA is monitoring these new developments closely and will ask you to take action when and if appropriate.  We are also exploring the possibility that the FDA is deliberately hiding information that should be available under the Freedom of Information Act (FOIA).

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