OTC/Supplement Combos Offer Opportunity

It’s all about convenience. Wal-Marts have groceries, pharmacies, clothing, even full-service banks inside. Fast food restaurants offer value meals. Gas stations have coffee shops, ATMs and even dry cleaners attached. Ever go shopping for a pair of pants, and come home with the jacket, tie and socks too? Cross-selling works. Especially when you offer consumers what they want combined with convenience and little extra effort on their part.

So why shouldn’t the pursuit for health and wellness take a page from this book? And why are some in the dietary supplement industry crying foul on an opportunity to cross- market healthy products that give consumers what they want? I’m referring, of course, to the recent dust up over combination over-the-counter (OTC) drug/dietary supplement products. One combines low dosage aspirin with phytosterols, and another combines low dosage aspirin with calcium.

Back in 2001, FDA responded negatively to the introduction of specific OTC drug/supplement combinations with acetaminophen by insisting that the presence of a drug ingredient in a product rendered the entire product a drug, thus requiring drug-level approval for any ingredients in the product. Those companies voluntarily withdrew their products.

But times were different then and, more importantly, the ingredients were different, too. In both cases where FDA issued warning letters, the OTC drug involved was acetaminophen. That was at a time when FDA was very concerned about the effects of over-usage of analgesics. The combination products in question seemed to require contradictory labeling. One product combined acetaminophen with glucosamine. The problem was glucosamine requires daily ingestion over a period of time to show results, and the OTC monograph for acetaminophen specifically warns against extended daily usage of the drug. It was impossible for consumers to comply with both the drug labeling and the regimen necessary for the benefits of the supplement. But low dosage aspirin combined with phytosterols or calcium doesn’t have the same problem. These combinations are different because science supports the benefits of a daily aspirin for the prevention of heart attacks.

In fact, before FDA’s warning for the acetaminophen combination products, FDA had authoritatively addressed this issue in 1994 when it stated in the Federal Register: “FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labeling] 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.” That statement has never been revoked by FDA; the agency just didn’t believe the products in 2001 met that standard.

A bigger question today is why some in the industry seem eager for FDA to slam the door on drug/supplement combinations. Consumers would benefit (as would preventive health care in this country) from a variety of combinations of drug and supplement ingredients, and that would be good for the supplement industry as well. One of consumers’ major complaints is having to swallow so many pills. If ingredients are combined in a single pill, there are fewer pills to swallow, fewer pills to remember to take, and an easier ability for consumer to comply with labeling. Not to mention it’s more convenient for consumers—take your supplements on the go.