The FDA has implied interest in imposing a patently illegal restriction on the interstate commerce of nutrients and supplements if there has EVER been a scientific study published about the supplement.
Not only is that insane, creating a new category of dangerous substances that might be called “Anything anyone has ever studied that competes with drugs”, it is also in direct violation of US law, to say nothing of the Constitution of the United States.
The law it violates is a provision of the 2007 FDA Authorization Act that clearly states nothing in the Act shall apply to products covered by DSHEA, the 1994 Dietary Supplements Health and Education Act. Nonetheless, FDA is now questioning whether the Act’s Section 301(11) provision allowing FDA to stop interstate commerce in food substances ever studied for possible drug approval applies to dietary supplements (for details see the copy of our statement to the FDA below).
So this bizarre twist of logic, ingenious as it is, has nothing to do with legal authority by the FDA to ban supplements from interstate commerce – which it does not have.
But think about why the FDA would want to do that. Clearly, because nutrients are the single most significant economic competitor to drugs. Drugs are expensive. Nutrients are cheap. Drugs are dangerous. Nutrients are safe. Drugs kill people (23% of all adverse reactions reported to the FDA are fatalities). Nutrients do not kill people. Drug sales are reportedly off 13% in the economic downturn. Could it be that the pharmaceutical industry, which literally owns FDA decision making capacity (through permitted conflicts of interest, revolving door policies which put corporate executives in executive positions in the FDA and then the titles switch so that the same person now has a corporate executive position instead of an FDA position) and through user fees might be serving the interests of its economic masters? It certainly appears that way.
Natural Solutions Foundation is proud to have risen to the challenge because of hundreds of thousands of health freedom advocates when the FDA Authorization Act of 2007 was being debated and brought the issue squarely home to Senator Harkin (R-IL). The Senator introduced an amendment which protected all DSHEA products. Now the FDA is flagrantly ignoring the law of the land.
Health freedom advocates can go to http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=26269 to let the FDA know that this attack on supplements and other DSHEA products is illegal under US law.
You can read the formal comments of the Natural Solutions Foundation to the FDA about this issue below.
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Yours in health and freedom,
Rima E. Laibow, MD
Natural Solutions Foundation
Comments of Natural Solutions Foundation to the FDA Regarding Comments Request
Natural Solutions Foundation is a Non-Governmental Organization (NGO) consumer group organized as an exempt entity in the United States (State of Nevada) and in several other countries. Our primary web site is www.HealthFreedomUSA.org and we have over 185,000 supporters, primarily Americans.
These comments address the third question raised by FDA in its call for comments, namely how the Section 301(11) restrictions on commerce might apply to dietary supplements, thereby restricting consumer choice.
National Solutions Foundation was one of the institutions that helped educate members of Congress and other decision makers regarding the relationship of Dietary Supplements regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA) to the enhanced authority granted FDA by Congress in the 2007 Food and Drug Act Amendments.
Due to determined public expression, including messages to Congress by hundreds of thousands of citizens, section 1011 of the Act was included, the Rule of Construction that states, “Nothing in this title (or an amendment made by this title) shall be construed to affect– (1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417)”
The 301(11) restrictions must be interpreted under the exemption for DSHEA products intended by Section 1011. As a result, DSHEA products must be allowed in interstate commerce without interference by the provisions of section 301(11).
However, the same requirement of law does not apply to food products that contain “trace” or more amounts of extraneous hormones, pesticides, pharmaceuticals, including antibiotics, irradiation break-down products and other toxins introduced to food during its processing. Such adulterated foods should not be on the market.
In its unseemly reach for more authority to restrict consumer choice in nutrients the FDA seeks to ignore the plain Congressional intent of Section 1011 and the unanimous Congressional intent of DSHEA that Dietary Supplements are foods, deemed safe when used as directed.
In this way, FDA continues to exhibit why it is time for Congress to consider divesting FDA of its food authority. FDA has failed to protect the American food supply and is institutionally incapable of responding constructively to consumer choice in nutrition.
Ralph Fucetola JD