By guest-blogger Steven Shapiro, Esq.

I was asked to offer a comment, from my legal point of view, on a new product consisting of cherry-flavored dextrose called, “Obecalp”, which coincidentally happens to be the word “placebo” spelled backwards.

According to an article in the May 27, 2008, The New York Times, “Experts Question Placebo Pill for Children,” “Because they contain no active drug, the pills will not be sold as a drug under Food and Drug Administration rules. They will be marketed as dietary supplements, meaning they can be sold at groceries, drug stores and discount stores and discount stores without a prescription.”

Unfortunately, the quoted statement from the newspaper and the product idea itself seem to reflect a lack of a basic understanding of how drugs and dietary supplements are regulated in this country. In many cases, how a product is regulated may not depend on what is in it, so much as what is said or claimed about it. This is an issue that frequently arises when I am discussing U.S. Food and Drug law with people from other countries where the regulatory schemes are radically different.

By way of analogy, if I tell you to drink orange juice because it tastes good that is a conventional food. If I somehow label the orange as a dietary supplement and market it for its antioxidant value, it may be a dietary supplement. On the other hand, if I market that orange for its ability to treat a neurodegenerative disease based on its antioxidant content, I have now made it an unapproved new drug, despite the fact that it does not contain an “active drug”.

Take a look at the FDA dietary supplement structure /function disclaimer: “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.” Let’s bold, underline and highlight the word “intended”.

“Obecalp” is intended to fool the child or unknowing person taking it into believing that they are taking “real medicine” for the purpose of treating some disease or ailment, whether real or imagined. And, for this reason, the product is intended to be used as a “drug” and is, therefore, not a dietary supplement.

On a purely personal point of view, I do not like the idea of giving a child what is essentially a piece of candy, masquerading as a drug, masquerading as a dietary supplement and telling him or her that it will make whatever hurts go away. Medicine should really be medicine, just like something marketed as a dietary supplement should really be a dietary supplement.

STEVEN SHAPIRO is a partner in the New York City firm of Ullman, Shapiro & Ullman, LLP. He advises clients on food and drug law matters relating to the manufacture and marketing of foods, dietary supplements, drugs, and cosmetics, as well as advertising matters involving the Federal Trade Commission. His practice concentrates on areas of interest to the natural products industry and spends much of his time advising companies on the intricacies of DSHEA as it relates to the marketing of dietary supplements. He is a contributor to many natural product trade magazines and a frequent lecturer on topics of concern to the natural products industry at tradeshows and for the Food and Drug Law Institute where he is a member of the Food and Dietary Supplement Committee. He can be reached at ss (at) usulaw.com or www.usulaw.com