Free Speech and Food Supplements
In 1994, Congress passed the DSHEA, the Dietary Supplement Health and Education Act, after millions of Americans wrote letters to prevent the Food and Drug Administration from being able to ban information on dietary supplements. Now the FDA again wants to limit the rights of consumers to be informed and the rights of the supplement manufacturers to provide information. The FDA will get around DSHEA by redefining the term "disease" and what constitutes a "disease claim," unless it hears from 100,000 Americans who object to the change. The original deadline for comments was August 27, but it was extended to September 28.
The proposed new regulations were issued on April 27, 1998. Federal law currently prohibits a label on a supplement from claiming an effect on a disease. They can't say that their supplement will prevent cancer. The new regulations will expand the meaning of disease to include aging, pregnancy, and other natural aspects of life. Supplement labels will also not be able to say the product has an effect on symptoms, such as a headache.
The proposed regulations go even further and prohibit the citation of a publication about a disease, even from a respected academic journal. Pictures suggesting an effect on disease will also be banned. If there is any hint that the product prevents or treats a disease, or any reference to such literature, then the product will have to be approved as a drug under the Federal Good, Drug, and Cosmetic Act.
So the maker of a food supplement such as vitamins or herbs are not allowed to tell you on the label how the product can improve your health and prevent diseases, or even let you know of the research and publications that provide the evidence.
If you think the FDA is restricting free speech, that information on the benefits of food supplements should be available, and that you do not want the FDA to redefine a "disease," you may write to the FDA to express your viewpoint. Letters can be faxed to 301/827-6870 or mailed to: Dockets Management Branch (HFA-305), FDA, Attn: Docket #98N-0044, c/o Michael Friedman, M.D., Lead Deputy Commissioner, 5630 Fishers Land, Rm. 1061, Rockville MD 20857.
Some may argue that the public has to be protected from false or uncertain claims. There are indeed a lot of hype and dubious claims, exploiting fears about sickness and desires to find quick fixes for losing weight. Some companies exploit people's fears about nutritional deficiencies with products that may do no good. But these misleading claims can be handled by laws on fraud. The consumer has a right to be informed, and the producer has an obligation to be truthful. The government could help by making it easier and less costly to sue for fraud or damage. But in prohibiting even truthful information, the proposed regulations violate free speech and free enterprise. The proposed rules may also prevent people from getting and staying healthy.
Food supplements - vitamins, herbs, powders - are not a substitute for a healthful diet. We should get most of our nutrition from food, not pills. To be healthy, we should eat foods that are as natural as possible, especially raw, organically grown fruits, grains, and vegetables. But research has also shown that some supplements can help in general and in specific situations. The government violates our rights to health and liberty by denying us information and products that can preserve and boost our health.