The United States has come to a decision point on nutritional supplements. Choice A is to continue participating in the Codex Alimentarius Commission (Codex), which could be hazardous to public health by setting limitations on supplements, and Choice B is to pass the Health Freedom Protection Act (HFPA), which could revolutionize the health supplement industry and greatly benefit public health, in part by no longer allowing the FDA to prohibit disease treatment claims for foods and supplements.
U.S. Rep. Ron Paul (R-Texas) said in his Nov. 10, 2005 speech before the U.S. House of Representatives, "Because of the FDA's censorship of truthful health claims, millions of Americans may suffer with diseases and other healthcare problems they may have avoided by using dietary supplements." Paul cited the FDA's four-year prohibition of telling consumers that folic acid reduces birth defects, which resulted in an estimated 10,000 cases of preventable birth defects, as evidence that the FDA's current policy obstructs good public health.
We're at a fork in the road, so to speak. If the United States' participation in Codex continues, things could get much worse than they are already. However, if Congress passes the HFPA, the U.S. could be entering a new era in health care, when consumers will be allowed to make informed decisions about which nutritional supplements they want to use to support good health.
The Health Freedom Protection Act is relatively simple, yet it could mean so much, not only to proponents of alternative medicine, but to public health care in general. In Paul's words, the HFPA merely allows consumers to have access to information about nutritional supplements: "Specifically, the Health Freedom Protection Act stops the FDA from censoring truthful claims about the curative, mitigative or preventable effects of dietary supplements, and adopts the federal court's suggested use of disclaimers as an alternative to censorship."
Dietary Supplement Health and Education Act (DSHEA)
This topic of disclaimers first came up in the Dietary Supplement Health and Education Act of 1994 (DSHEA), which first decreed which statements nutritional supplement companies could and could not make about their products. The law reads, "Under DSHEA, firms can make statements about classical nutrient deficiency diseases -- as long as these statements disclose the prevalence of the disease in the United States. In addition, manufacturers may describe the supplement's effects on 'structure or function' of the body or the 'well-being' achieved by consuming the dietary ingredient. To use these claims, manufacturers must have substantiation that the statements are truthful and not misleading and the product label must bear the statement: 'This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.'"
As any trip down the supplement aisle of your local grocery store or health food store will tell you, nutritional companies are following the DSHEA's disclaimer guidelines to the tee, yet the FDA still insists on censoring these products' proposed health benefits -- statements that definitely fall under the category of "the supplement's effects on 'structure or function' of the body," such as the DSHEA allows.
In his Nov. 10 speech, Paul went on to say, "The Health Freedom Protection Act also stops the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease."
One of the DSHEA's main goals is for the public to have access to scientific information on nutritional supplements, stating, "The DSHEA provides that retail outlets may make available 'third-party' materials to help inform consumers about any health-related benefits of dietary supplements. These materials include articles, book chapters, scientific abstracts, or other third-party publications."
FDA suppression of health information and free speech
Now, 12 years after Congress' passage of the DSHEA, the FDA continues to limit the public's access to the very information that the 1994 act prescribes. Paul addressed this issue in his speech, accusing the FDA of violating First Amendment free speech rights. "FDA bureaucrats are so determined to frustrate consumer access to truthful information that they are even evading their duty to comply with four federal court decisions [such as the 1999 case Pearson v. Shalala] vindicating consumers' First Amendment rights to discover the health benefits of foods and dietary supplements."
Furthermore, free speech (or the lack thereof) is a major factor in both the FDA's and the Federal Trade Commission's (FTC) restriction of the nutritional supplement industry. By Paul's reasoning, the FTC's censorship on supplements' health claims completely reverses the U.S. government's notion of free speech, a concept that has been essential to the United States since its birth as a nation. Paul explains, "Under traditional First Amendment jurisprudence, the federal government bears the burden of proving an advertising statement false before censoring that statement. However, the FTC has reversed the standard in the case of dietary supplements by requiring supplement manufacturers to satisfy an unobtainable standard of proof that their statement is true."
Paul isn't alone in his belief that the FDA's standards for nutritional supplement companies are unrealistic. In fact, in the 1999 case of Pearson v. Shalala, the United States Court of Appeals for the DC Circuit Court decided that, in the case of nutritional supplements, "the mere absence of significant evidence in support of a particular claim does not translate into negative evidence against it."
Even after the 1994 DSHEA and the 1999 case of Pearson v. Shalala, the FDA regularly suppresses health benefit information on nutritional supplements and sometimes even the distribution of the supplements themselves. Though the FDA often overlooks the DSHEA's goal of making scientific information on nutritional supplements more available to the public, it readily exercises the Federal Food, Drug and Cosmetic Act (FD & C), most specifically its definition of drugs. The FD & C, which is best-known for making it mandatory to list food coloring additives in 1938, states that, "the term 'drug' means ... articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals." In other words, whenever a nutritional supplement claims to prevent disease, the FDA can, based on the FD & C, term it a "drug" and apply the same standards demanded of a new pharmaceutical before allowing the nutritional supplement to enter the consumer market.
This is where the problem arises. Because products of nature cannot be patented, it is simply not economically feasible for companies to run millions of dollars of tests on a nutritional supplement, which is a natural substance. This is why pharmaceutical companies take natural substances and break them apart at a molecular level to make the isolated active ingredients patentable.
FDA suppression in action: Optimal Nutrients
The FDA's Feb. 2, 2005 letter to Tim Lally of Optimal Nutrients offers a sad but remarkable picture of this "unobtainable standard of proof" in action. Dr. Susan J. Walker, the director of the FDA's Division of Dietary Supplement Programs, begins a letter to Lally by listing the "offending" products listed on his website and referencing the FD & C's definition of drugs:
"This is to advise you that the Food and Drug Administration (FDA) has reviewed your website ... and has determined that the products Borage, EPA (Fish Lipid Concentrate), Flax (100% Organic Flax Seed Oil), Evening Primrose Oil, Attention Support, Barley (Barley Juice Powder), Cat’s Claw, CoQ10 (Co-Enzyme Q10), DHEA (Dehydroepiandrosterone), St. John’s wort and Valerian Root are promoted for conditions that cause these products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of diseases."
Flax seed is a drug? Of course not, but according to Dr. Walker, Optimal Nutrients' following statement makes it a drug under FD & C: "Flax Seed Oil is an important source of alpha-linolenic acid (ALA), an Omega 3 series of essential fatty acids. ALA is the precursor to EPA and the Series 3 prostaglandins ... 3PGEs protect the body against the deleterious effects of high blood pressure."
It's interesting that, throughout the entire letter, Dr. Walker never references the much more recent DSHEA, especially considering that, again, the 1994 act specifically states that "manufacturers may describe the supplement's effects on 'structure or function' of the body or the 'well-being' achieved by consuming the dietary ingredient." In its claim about flax seed oil, the company simply describes ALA's "effects on 'structure or function' of the body" ("ALA is the precursor to EPA and the Series 3 prostaglandins ... 3PGEs protect the body against the deleterious effects of high blood pressure"), which is of course permissible by DSHEA standards.
Then, later on in the letter, Dr. Walker takes the second step in the FDA's classification of nutritional supplements as drugs by requiring Optimal Nutrients' natural products to go through the same approval process as new pharmaceuticals. She writes:
"Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are ... 'new drugs' under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drugs are safe and effective."
Obviously it would not be economically feasible for Optimal Nutrients to run millions of dollars worth of tests on substances that, as products of nature, are not patentable. Today, the Optimal Nutrients web site has no products listed on it and reads that it is "under construction." Unfortunately, this is just one of many nutritional supplement companies oppressed by the "unobtainable standard of proof" that Paul spoke of in his speech before Congress.
Don't put your health freedom in the hands of the government
As if this present war against nutritional supplements was not enough, the situation could get worse. In their Congressional Oversight Letter, Paul and fellow U.S. Rep. Peter DeFazio (D-Ore.) express concern about the United States' participation in the Codex Alimentarius Commission (Codex), which is part of the Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) Food Standard Program. Through Codex, the WTO hopes to "harmonize" food and other safety regulations of all WTO countries; however, it also serves to put power in the hands of national and international agencies and out of the hands of consumers. For example, Codex's 2005 Guidelines for Vitamin and Mineral Supplements reads, "Vitamin and mineral food supplements should contain vitamins/provitamins and minerals whose nutritional value for human beings has been proven by scientific data and whose status as vitamins and minerals is recognized by FAO and WHO."
The field of nutrition is constantly growing with new and remarkable products. With this in mind, putting the sole right to judge a product's worth on FAO and WHO severely limits consumers' rights to choose groundbreaking products that FAO and WHO may simply not be aware of yet.
Codex's use of the term "harmonization" gives the illusion that the WTO is working to better the world, bringing diverse nations into a state of harmony, but that is not the reality. Codex is little more than an attempt by Big Business to further control the global economy and put more money in pockets that are already deep. In fact, in their Congressional Oversight Letter, Paul and Defazio give this warning: "Harmonization may be beneficial for the large corporations and international businesses that control the WTO, but it would be a disaster for American consumers of dietary supplements!" In other words, don't let the choice words fool you. As is all too often the case with public policy, money talks louder than the public good.
If the United States' participation in Codex continues, Paul and DeFazio worry that the WTO will pressure the United States to enforce draconian policies on nutritional supplements. They write, "We are concerned that the end result of this process will force the United States to adopt the same strict regulations of dietary supplements common in European countries such as Germany, where consumers cannot even examine a bottle of dietary supplements without a pharmacist's permission."
Can you imagine living in a society like that? Most consumers would not want to live in such a society and, according to Paul and DeFazio's interpretation of past legislation, neither would Congress. "By participating in this process, the FDA is ignoring the will of Congress as expressed in DSHEA and in the FDA Modernization Act of 1997, which expressively forbid the FDA from participating in the harmonization process, as well as the will of the American people," they explain.
Paul and DeFazio end their Congressional Oversight Letter with the following wish: "We also express our hope that Congress will act to protect the freedom of American consumers from overregulation of dietary supplements whether imposed by the FDA or through the back door by an international organization such as the WTO."
Paul's proposed Health Freedom Protection Act is a step toward making that simple yet profound hope a reality. Currently, 10 congressmen co-sponsor the HFPA. They include Paul, DeFazio, Dan Burton (R-Ind.), Walter Jones (R-N.C.), Rob Bishop (R-Utah), John J. Duncan (R-Tenn.), Roscoe Bartlett (R-Md.), Jeff Miller (R-Fla.), Butch Otter (R-Idaho) and Tom Tancredo (R-Colo.). Hopefully, this number will grow. You can do your part by visiting the Health Action Center web site and sending the online letter to your U.S. representative. It will take only one or two minutes to do, and it won't even cost you a postage stamp. Remember, you don't want to live in a nation in which you need a pharmacist's permission to look at a bottle of vitamins.
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