Combination OTC drug/dietary supplement products with dual or "split" labels can meet FDA requirements if each portion of labeling complies with the relevant FDA regulations, D.C. attorney Peter Barton Hutt (Covington & Burling), suggested at the Functional Foods for Health annual meeting in Bloomingdale, Ill. May 17-19.

Hutt's presentation addressed innovative ways of using the structure/function claims appropriate for supplements. He mentioned the split label approach in the context of a product that contains both echinacea and an OTC cough/cold ingredient. Functional Foods for Health is a joint research, education and communication program of the University of Illinois at Chicago and the University of Illinois at Urbana-Champaign.

Because one of the "leading words that FDA hates is the word cold" in a structure/function claim, Hutt said, one way of solving the problem is to "take a label and...split it right down the middle" and make the product a combination with supplement information on one side and OTC information on the other.

This approach is permissible under food and drug law, Hutt advised, by "creatively transferring" the policy governing combination cosmetic drug products to the dietary supplement and OTC drug industries. He cited deodorant/antiperspirant, antidandruff shampoo and sunscreen products as among the combination cosmetic-drugs that carry dual labeling.

The combination label for the OTC/supplement product would bear the brand name across the top. "On the left hand side...a dietary supplement X, say echinacea" would be listed, and, "on the right hand side, we will put into this product with echinacea, a Category I OTC drug active ingredient, dextromethorphan or any antitussive."

The claims for echinacea would be an ingredient statement such as "Contains echinacea," Hutt continued, while the claims for the OTC ingredient will have "hard core cough/cold claims...exactly what the over-the-counter monograph for cough/cold products says."

The type of combination labeling Hutt referred to is being used on a melatonin/acetaminophen product introduced recently by B.F. Ascher called Melagesic PM ("The Tan Sheet" May 3, In Brief).

Hutt also discussed labeling a conventional food as a dietary supplement. He asserted that despite the regulatory barriers McNeil encountered when it attempted to market its Benecol spread as a dietary supplement, the law "unequivocally was changed...to permit a dietary supplement in food form" (see related story, p. 12)

"In fact, as you know, FDA stated cranberry juice...is a good example of a conventional food form that can be marketed as a dietary supplement," Hutt pointed out.

FDA has indicated "there are some products that are inherently conventional foods and some that...even though they are conventional foods, can be sold" as dietary supplements, such as beverages and bars, Hutt noted. However, he pointed out the agency's policy on the line between conventional foods and dietary supplements remains unclear.

A marketer interested in a heart disease prevention claim citing clinical data that links an ingredient to cholesterol reduction might consider fashioning a health claim based on an "authoritative statement" by a government scientific body, Hutt said.

He suggested "a whole chapter of the Surgeon General's report on diet and health on the relationship between serum cholesterol and heart disease" could be used as a package insert and submitted to FDA as an authoritative statement claim.

"What is FDA going to say," Hutt asked. "Are they going to say the Surgeon General did not know what he was talking about? Are they going to say the Surgeon General is not an authoritative body? Are they going to say this is not an authoritative statement? Are they going to say, well then we will get the Surgeon General to withdraw it? I do not think so." Hutt cautioned, however, that such an approach should be based "not on the worst facts, but on the best facts."

A claim to lower cholesterol based on an authoritative statement that says "nothing about the relationship to heart disease," should not run into problems with FDA, Hutt predicted.

Hutt recommended against "making up your own claim" taken "out of the words of other people's mouths. He said a "review article or a synthesis of the available current scientific knowledge...is the strongest basis on which you can begin to make creative claims," adding, "Quote others who are very, very authoritative."

OTC/Dietary Supplement Combination With "Split Label" Fits FDA Rules - Hutt

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