Sleepers, Awake!

Wachet auf, ruft uns die Stimme
(Wake up, the voice calls to us)

— Johann Sebastian Bach
Cantata BWV 140

hile many of us have been sleeping, once again the FDA is trying to pull a fast one, by overriding the basic thrust of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This law unwaveringly states that food (including supplements) and drugs are to be treated separately, or in other words, foods are not drugs. The FDA’s new Rule is designated: FDA Docket No. FDA-2008-N-0389, “Prohibition Against Food to Which Drugs or Biological Products Have Been Added.” Here’s the FDA summary:

The Food and Drug Administration (FDA) is requesting comments relevant to the implementation of section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 912 of FDAAA establishes section 301(ll) in the Federal Food, Drug, and Cosmetic Act (the act), which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. FDA requests that interested persons submit data, information, and comments that will help provide a context for the agency’s decisions on implementation of this provision. To encourage responsive comments, FDA is including a series of questions for interested persons to consider in preparing comments. [Emphasis added.]*

*See http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17356.htm for the balance of the proposed Rule.

As you can tell, the FDA would prefer that DSHEA disappears. But clearly, it was the intent of Congress, with the passage of DSHEA, to maintain a separation between food and drugs, not to convert food into drugs. It is time to awaken to the meaning of this new potential travesty.

Thanks to Constitutional lawyer Jonathan Emord and Durk Pearson and Sandy Shaw (along with financial help from Spectrum Technology Service, Life Enhancement Products, Life Extension Foundation, Life Extension Foundation Buyers’ Club, and People for the Constitution, and research support from Life Enhancement Products) for filing comments that make the following points.

The proposed Rule:

  1. Violates the Administrative Procedure Act because the regulated class (food and supplement companies) cannot determine what is being proposed. How can one rationally comment on what is so unclear as the proposed rule?

  2. Provides incentive for arbitrary and capricious rulemaking.

  3. Favors the interests of drug companies over those of food companies, dietary supplement companies, market competitiveness, and consumer choice.

  4. Provides a perverse disincentive for foods companies or dietary supplement companies to conduct clinical trials.

  5. Violates the First Amendment.

  6. Authorizes powers that are not found in any congressional statute.

  7. Potentially bans many common foods or food constituents from being marketed as foods or dietary supplement under the proposed rule.

  8. Provides no small business economic impact statement.

  9. Violates the “takings” clause of the Fifth Amendment. The losses sustained, when scientific data—not having to do with health or safety issues—are used by FDA to prohibit further marketing of previously legal products, constitute such takings.

  10. Imposes huge risks of graft and corruption both at the FDA and at drug companies expecting to profit from its provisions.

  11. Effectively establishes a new type of patent of unlimited duration, without congressional intent or approval, whose nature contradicts extant patent statutes.

For these and other reasons, especially at this time of political change, we must be on guard. So if you haven’t become aware of this new usurpation of power yet, please give it your highest attention and resolve to be more proactive.

If we do not heed the voice that calls us to wake up, another voice—die stimme ihrer herren (the voice of the masters)—assuredly will. We must decide for ourselves through our conscious and enlightened choices the kind of rules we endorse and choose to live by. In the words of American abolitionist Wendell Phillips, “Eternal vigilance is the price of liberty.”

Live long and prosper,

Will Block

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