Health Freedom Briefings

A substance isn't transformed into a drug just because it has therapeutic properties. Foods are not drugs; nor are nutrients when taken as dietary supplements, and manufacturers should be able to make therapeutic claims on them as long as they are true.

This is the premise of H.R. 2868, the Consumer Health Free Speech Act, introduced in the U.S. House of Representatives by Rep. Ron Paul (R) of Texas. It is a simple, self-evident premise that should be enacted into law because of ongoing efforts by the Food and Drug Administration and similar agencies in other countries to regulate foods and supplements as drugs, as well as efforts by pharmaceutical companies to patent and gain FDA approval for exclusive rights to sell dietary supplements as drugs.

Currently Rep. Paul's bill has three co-sponsors and enjoys bipartisan support. We should all work hard to pass H.R. 2868 in the House. Following are a number of points that underscore the current threat to health freedom, and the need to back H.R. 2868.

• On January 12, Judge Gladys Kessler ruled against attorney Jonathan Emord's First Amendment lawsuit, declaring that the FDA's Final Rules did not violate the Nutrition Labeling and Education Act, nor the First and Fifth Amendments to the U.S. Constitution. She also ruled in favor of upholding the FDA's "significant scientific agreement" standard, which the agency arbitrarily uses to block the making of truthful claims for dietary supplements.
  
  There is a need to frame an appeal well enough to put this issue before the U.S. Supreme Court. A series of cases including Coors and 44 Liquormart seem to go in the direction that commercial speech is congruent with free speech as long as it is truthful and non-misleading, and validated by the best available science. Attorney Milt Bass has another First Amendment lawsuit in the U.S. Court of Appeals. Since there is never any guarantee of winning in the courts, we must also try to pass legislation to achieve the same end result, which is where H.R. 2868 comes in.
• On another front, PharmaPrint Inc. (traded on the Nasdaq stock exchange as PPRT) has big plans to patent our favorite herbs and license pharmaceutical companies to use their patented technology.
  
  The goal of PharmaPrint and other companies is to convert the multi-billion-dollar market for herbals into a pharmaceutical market. If successful, the cost of supplements would soar.
  
  PharmaPrint has the direct backing of the World Health Organization. To prove that a global move is afoot to take away freedom of access to herbs, see what PharmaPrint has to say on its website:
  
  "Pharmaprinting of a botanical drug costs approximately $500,000 and can be performed in about six months. It includes validating manufacturing under GMP guidelines and filing for patent protection. Phase I/II clinical trials take an additional 18 months to complete at a cost of about $1.5 million. This is followed by Phase III trials that take 2-3 years at an estimated cost of $5 million to $20 million. These figures are in sharp contrast to the estimated average cost of $230 million over a period of 12 years that is needed to complete development of a drug from the drug discovery stage to commercialization.
  
  "In addition to the major cost advantage of drugs made from botanical sources, there also is a greater likelihood of success in clinical trials because they have already shown evidence of therapeutic efficacy in humans prior to initiating formal clinical studies."
  
  
• The FDA's recent tobacco regulations were discussed by attorney Ellen J. Flannery of Covington & Burling in December at the Food and Drug Law Annual Meeting in Washington D.C. There is a very real need to get the food exemption into the drug definition because, as was made clear, the FDA can now use the tobacco rule to go after other areas, such as herbs and other dietary supplements. H.R. 2868 exempts foods from drug definitions. We must work together to pass it, and if there is a need to make some changes to improve it, that can be done in a Senate companion bill.
  
  With moves already afoot to try to repeal my amendment of the FDA Reform Bill which kept our food and drug laws from being harmonized with those of the European Union, we can't be too careful.
  
  If we don't stand firm on the principle that foods are not drugs, and if we don't work hard to pass H.R. 2868, market forces will inevitably usher in pharmaceutical domination of the industry.
  
  Please use the letter on the following page to guide you in urging your congressional representatives to support H.R. 2868. For further information on the fight to preserve freedom in health care, visit the IAHF website: (http://www.iahf.com/)
  
  You may download a longer version of this article from the breaking news section. If you are not online, please ask your local librarian to assist you.
  
  -John C. Hammell
  International Advocates for
  Health Freedom
  Please Co-sponsor the Consumer Health Free Speech Act (H.R. 2868)
  
  

TO: The Honorable ____________________
United States House of Representatives
Washington, D.C., 20515


Dear Congressional Representative:
The Consumer Health Free Speech Act, recently introduced into the House by Rep. Ron Paul (R-Texas), is needed to preserve freedom of choice in health care in the United States. This will help Americans learn about the scientific advances in nutrition occurring today by allowing truthful health claims for foods and dietary supplements. The bill proposes the following changes:
FIRST: The present definition of the term "drug" in the Food Drug & Cosmetic Act (FDCA) is so overly broad that it includes foods, herbs and dietary supplements. The present flawed definition reads: "The term 'drug' means articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man . . ."
Congressman Paul's bill would add three words, "other than food," immediately following the word "articles," so that it would read:
"The term 'drug' means articles, other than food, intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man . . ."
Adding these three words would exempt all foods (which includes herbs and other dietary supplements) from being regulated as drugs by the FDA. It would also prevent the FDA from banning truthful health claims based upon scientific evidence for these foods simply because they haven't been approved as "drug" claims by the FDA.
Scientific research in nutrition has shown that herbs and other dietary supplements are safe and effective in preventing many diseases. However, the flawed definition of the term drug makes it a federal crime for the dietary supplement industry to give this truthful information to consumers in labeling herbs or other dietary supplements.
SECOND: Wording in section 403 of the FDCA gives the FDA excessive powers over herbs and dietary supplements. It proclaims, "A food shall be deemed to be misbranded if its labeling is false or misleading in any particular . . ."
Consumer Health Free Speech Act would change "false or misleading" to "false and misleading." Changing the "or" to "and" will set a higher and fairer standard that the FDA must meet before limiting or banning the sale of herbs or other dietary supplements by claiming they present an unreasonable "risk."

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