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.

Supplement/drug combined usage is really nothing new. FDA has long permitted calcium carbonate to be marketed as both an antacid and as a calcium supplement and for psyllium to be marketed as both a fiber supplement and a laxative. These products are simultaneously labeled with both sets of claims and with both a “Supplement Facts” and a “Drug Facts” box on the label. So why can’t consumers understand a similar product that combines two ingredients rather that promotes one ingredient for two purposes?

Consider the possibilities for combinations of ingredients as well the opportunities for co-packaging: i.e., low dosage aspirin with vitamin D; OTC allergy medicines that also provide an anti-inflammatory supplement; if statins eventually get OTC approval, combining a statin drug along with coenzyme Q10 (CoQ10) to offset the CoQ10 depletion that typically occurs with these drugs; even co-packaging a weight loss drug with a multivitamin to assure users get sufficient nutrients, many of which don’t get absorbed because of the fat-blocking effects of the drug. The cross-marketing opportunities are abundant and the supplement industry should be encouraging this type of thinking.

From a manufacturer’s perspective, the benefits are abundant, too. As supplement manufacturers are already well-attuned to the desires of their customers, they are readily positioned to develop these products themselves or to reach licensing agreements with OTC manufacturers. In the same way Burger King now sells Minute Maid orange juice, and the Duncan Hines Brownie mixes include “real Hershey’s syrup inside” (because they know their customers respond positively to brands they already buy), combination product marketers from the drug side would do well to use branded supplement ingredients that already have a consumer awareness and following. Besides, anything that brings consumer interest and excitement to the category is bound to have a positive lift on the entire sector.

All too often, members of the supplement community level criticism at health care practitioners for not practicing integrative medicine and for not including diet and supplementation in the total composite of wellness. And all too often, the natural products industry criticizes doctors when they prescribe drugs but don’t consider a more holistic approach. Supplement/drug combinations encourage an integrative approach to wellness and also have the potential to draw positive awareness to supplements among health care practitioners. But putting up barriers to these products or encouraging FDA to prohibit these combinations only reinforces the divide at a time when we should be looking for ways to show the medical community that dietary supplements have a critical role in prevention and wellness. Integrative medicine should lead to integrated products.

Instead, this is an opportunity to encourage FDA to embrace products that make sense and help make consumer’s lives better. When dietary supplements and OTC drugs can provide either independent or even synergistic positive effects in a single pill, the agency should give these products their blessing. And when that happens, consumers will be well-served and supplement ingredient suppliers and finished product manufacturers alike may find these new marketing opportunities lead to new profits as well. Opportunity is knocking; let’s answer the door.  Steve Mister is the president and CEO of the Council for Responsible Nutrition (CRN), a Washington, D.C.-based trade association representing dietary supplement industry ingredient suppliers and manufacturers.