FDA Proposes New Health Claim Rules
By Jeffrey A. Babener
Excerpted from Network Marketing: What You Should
Know, Jeffrey Babener, Legaline Publications
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The President Speaks
It is officially called the Dietary Supplement Health and Education Act of 1994 and it was signed into law in October, 1994. It has had profound impact on the network marketing industry, an industry which is historically dominated by the sale of nutritional and dietary supplements.
It was not necessarily an end to the war between the FDA and the health food supplement industry, but it was a major victory for marketers of vitamins and dietary supplements. At issue in the battle has always been whether or not the industry could market its vitamins, amino acids, nutritional supplements, etc. and what could be said about their products. From time to time, the industry has been labeled by the FDA as a bunch of snake oil salesman, and the industry has accused the FDA of inflexibility and intolerance of its products and health messages. As late as the 1980s, the FDA was accusing breakfast cereal manufacturers of peddling drugs because of health messages regarding the relationship between fiber and cancer. Over the ensuing years, the FDA began to recognize the role and relationship between diet and disease, but the love-hate relationship between the FDA and health food industry continued to cycle every few years.
Prior to the 1994 legislation, relations between the FDA and the dietary supplement industry reached a new low. The industry was genuinely concerned that the FDA's new proposals might mean an end to a variety of dietary supplements on the shelf, as well as a stifling of the communication of dietary supplement information to the public. Senator Orrin Hatch and Congressman Bill Richardson ushered through Congress the Dietary Supplement Health and Education Act of 1994 to protect the right of the industry to distribute its products and disseminate information. Although it doesn't accomplish everything the industry wanted, the industry breathed a major sigh of relief at its passage. At its bare bones, the new legislation does the following:
1. Allows third-party literature about dietary supplements to be disseminated,
2. Allows labels on dietary supplements to describe how supplements provide nutritional or dietary support for a person,
3. Places the burden of proof that a dietary supplement is unsafe on the FDA,
4. Provides that the dietary supplements are not "food additives," and that the FDA may not arbitrarily remove supplements from the marketplace by labeling them as unapproved "food additives,"
5. The Act provided for a presidential commission
of unbiased experts in dietary supplements during the next two years to
provide recommendations and establish procedures for evaluating health
claim label statements. After that the FDA was to issue proposed rules
and invite public comment.
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