Drug or supplement?

When I saw the Bayer Aspirin with Heart Advantage split tablet of low-dose aspirin and phytosterols, my first reaction was, "Finally, an integrative approach to heart-disease prevention. Perhaps now the medical community will take notice." My counterpart at NPICenter.com, Len Monheit, had a different reaction. "Red herring," Len said, for the single reason that supplements and OTC drugs are classified in very separate regulatory pillars. Rudyard Kipling's phrase from Barrack Room Ballads in 1892 came to mind, "Oh, East is East, and West is West, and never the twain shall meet."

Monheit's predictions were correct. My optimism was crushed when in October the FDA issued two warning letters stating that these two products were "unlawful" (see www.functionalingredientsmag.com for the news story). Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, made this statement: "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health-care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations." To date, no adverse reports have been made for either Bayer product.

Though, when one reads the historical fine print my optimism may still be warranted. According to the Council for Responsible Nutrition's president and CEO, Steven Mister, "as far back as 1994, the Agency stated in the Federal Register that the 'FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labelling] under all circumstances. Such claims may be permissible if a firm can demonstrate that dual claims can be made in a manner that will neither misbrand the product nor create a safety problem' (59 Fed. Reg. 395, 419, January 4, 1994). That statement has never been revoked."

In June, the American Herbal Products Association (AHPA) sent letters to the FDA asking for clarification. AHPA president Michael McGuffin stated that if indeed this product goes against policy, evaluation is warranted. "If, on the other hand, there is a new policy, it appears as if the marketplace may now be open to other OTC drug/dietary-supplement products."

In the coming year, we predict that the issue of combination OTC-supplement products reinforces four consumer-driven demands within this market: personalisation, convenience, self care and condition specific. According to a Nutrition Business Journal (NBJ) report "the top 16 health conditions — which range from general health to vision health — accounted for 92 per cent of US supplements sales in 2007." The top three categories were cold/flu/immune, joint health and heart health. With these trends in mind, it is no wonder that Bayer recognized a market opportunity and is now faced with asking for forgiveness rather than permission.

In this month's issue of Fi, we continue to address the ever-growing demand for self-care options with our focus on novel uses for building-block vitamins such as vitamins D and K, and two features on cognitive health: Brain enhancers and Phospholipids: New uses for an old friend.

May you be well,

Kimberly Stewart
Editorial Director
[email protected]

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