Dietary Supplement Health and Education Act of 1994
Signed into law by President Bill Clinton on October 25, 1994, the Dietary Supplement Health and Education Act [DSHEA] amended the Food Drug and Cosmetic Act. Several provisions apply only to dietary supplements and ingredients of dietary supplements. The DSHEA created a new framework for the safety and labeling of dietary supplements.
By this act Congress has stated that there is a positive relationship between sound dietary practice and good health. They signaled that further scientific research is needed to work on the connection between dietary supplement use, reduced health-care expenses and disease prevention. Yet even if the research is done, there is a hidden barrier. Supplements cannot make claims regarding disease without becoming regulated as drugs. Supplements can make substantial "statements of nutritional support," but cannot make hard claims without invoking FDA Control as a drug. This is for ruinous economic consequences.
Health supplement manufactures who market powders and extracts of narcissus pseudonarcissus (daffodil), must speak in terms of promoting healthy memory balance. The principle component of the daffodil is galanthamine. Manufactures of galanthamine (Reminyl) can claim it is a treatment of cognitive symptoms of Alzheimers disease. The manufacturers of galanthamine paid over $500 million to develop this claim.
Highly beneficial to the Health Supplement industry, the DSHEA made the supplement company responsible for determining that a product is safe and that representations of claims made about their product are not false or misleading. This means that dietary supplements do not need approval from the FDA before going to market.
Simply stated:
-Drugs ... treat, cure, diagnose or prevent abnormal states.
-Dietary supplements ....maintain normal, healthy, or improved physiologic (natural) states
DSHEA defines a dietary supplement as a 'natural substance which goes beyond essential nutrients to include other substances such as ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these.' Restated int detail, according to the DSHEA, a dietary supplement is:
a product, other than tobacco, which is used in conjunction with a healthy diet and contains one or more of the following dietary ingredients: a vitamin, mineral, herb, or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients. It is intended for ingestion in a pill, capsule, tablet, gel or liquid form. It is not represented for use as a conventional food or as the sole item of a meal or diet.
The product is labeled as a "dietary supplement."
The FDA can remove health supplements for:
- Significant and unreasonable risk by the product
- Poisonous or Deleterious Substances, in which the FDA believes it may render injury under the recommended or suggested conditions indicated on the products label
- The product is "unfit for food" (i.e. consumption).
- The product makes drug claims. If the supplements label indicated that the product can diagnose, cure, mitigate, treat, or prevent a disease, then it is clearly being represented as a "drug" and is no longer considered a dietary supplement.
- Truthful and informative labeling is lacking. All dietrary supplement products must contain extensive informative labeling, including detailed information about the nutrients in the product, such as name and quantity of all ingredients in the product and the name and place of business of the company.
- The label does not have the two disclaimers:
"This statement has not been evaluated by the Food and Drug Administration."
And
"This product is not intended to diagnose, treat, cure, or prevent any disease."
In summary, DSHEA is a very important legislation for Americans who which to preserve their health by means of dietary supplements. Recall Hippocrates advanced the quaint notion that "food is medicine." To maintain free access to health medicine via food and supplements, the public needs to be constantly vigilant. Practically every session of Congress has new proposed legislation to incremental controls the health supplement industry. Where tried control of your health by central committees does not work. Over a period of ten to twenty years the process is so politicized that the result is the opposite of the original intent.
To your health, William K. Summers, M.D.
