Health Supplements

Open Letter to the President

Dear President Clinton:

I urge you to actively support and lobby Congress to pass The Supplement Health and Education Act of 1993. which provides necessary definitions and direction for the FDA, introduced as bicameral, bipartisan legislation by by Congressman Bill Richardson (H.R. 1709) and Senator Orrin Hatch (S.784). Under the Bush Administration the FDA substantially expanded its scope of operation by misapplying the thirty-five year old amendment to the Food, Drug and Cosmetic Act (FDCA) passed by Congress to regulate and ensure the safety of new chemical additives which were entering the market, to substances which have been traditionally recognized as food or food supplements. I believe that the FDA's action warrants specific direction by Congress. Please lobby Congress to see that these bills are passed.

For example, the FDA seized two barrels of black currant oil (BCO), claiming it was a food additive because it had been placed in gelatin capsules. U.S. District Court for the Central District of Illinois denied the FDA's attempt to dispose of the case without trial on April 10, 1991, and found in favor of Traco Labs, on the grounds that the FDA had failed to make its case, and stated that simply adding BCO to gelatin capsules did not make BCO a food additive. In November the court dismissed the FDA's case because the FDA had nothing further to add to its position.

The FDA appealed the decision on October 21, 1992 to the United States Court of Appeals for the Seventh Circuit. In its judgment, rendered January 27, 1993, the appeals court affirmed the lower court decision and found in favor of Traco. Writing for the court, Judge Cudahy stated that "the Act (FDCA) distinguishes between food additives and food in the generic sense, this distinction being critical ... The FDA's food additive definition is so broad, however, that it would blur this distinction. It would classify every component of food -- even single active ingredients -- as food additives. Thus, it would seem, even the addition of water to food would make the food a food additive. The only justification for this Alice-in-Wonderland approach is to allow the FDA to make an end-run around the statutory scheme..."

The court decision stated: "The FDA's interpretation would also arbitrarily classify a substance as either a food or a food additive by how it is marketed rather than by the nature and use of the substance itself. The FDA concedes that BCO marketed in bottles instead of capsule form is not a food additive... How a product is marketed is not a rational way of determining whether a substance is a food additive."

An identical case was won in the First Circuit Court of Appeals on March 3, 1993. Leslie Kux, the FDA's Associate Chief Counsel for Enforcement declined comment saying, "the Black Currant Oil cases are still in litigation. Suffice it to say that we believe that our legal position is a sound one."

Even as a layman, it would seem that this legal position is ridiculous. The FDA regulations, do, as Judge Cudahy suggested, treat herbal teas as food additives arguing that the addition of an herb to hot water constitutes food additive status for that herb, while at the same time regulating true food additives that may be mixed into that herb. It should be obvious that the FDA needs further direction from Congress in determining what a food additive is and what constitutes nutritional substances.

I believe that the Dietary Supplement Health and Education Act of 1993, is necessary, if for no other reason than to stop the FDA from wasting valuable tax funds when it has more immediate budget concerns in meeting its primary function of quality and safety assurance. I also believe that an investigation of the FDA's reasons for pursuing such ridiculous cases in an already over-burdened court system is called for by Congress. I strongly urge you to support the Dietary Supplement Health and Education Act of 1993.