From The June 2000 Issue of Nutrition Science News

Back Talk

What Effect Will The Final Ruling On Structure/Function Claims Have?

by Stephanie Gailing

Under the 1994 Dietary Supplement Health and Education Act (DSHEA), manufacturers could make label claims only regarding a substance's effect on the structure or function of a bodily organ or system. On Jan. 6, 2000, the U.S. Food and Drug Administration (FDA) issued final rules on structure/function claims. Among the rules' landmarks was a clarified definition of "disease." The rules also altered the scope of what is considered an allowable claim and expanded acceptable claims into select OTC drug areas such as digestive aids and laxatives. At the same time, however, they also created an umbrella of off-limit claims such as those for allergy/hay fever and cold/flu season.

"The ruling is going to have a very big impact on the industry in ways that we do not yet understand. At this point, I think the industry has blindly accepted the ruling as a win, looking at it only from the perspective that FDA gave up on the disease definition issue and gave us a bunch of new claims previously reserved only for OTC drugs.

"While many in the industry are excited by the number of new claims they thought they got, I wonder how many have done a thorough evaluation of how good those allowable claims really are. While we can now make OTC claims for sour stomach relief and nighttime leg cramps—assuming that we have the safety and efficacy data—we lost the ability to make claims in really important areas like cholesterol and cold/flu. I believe that the latter claim areas are more significant to the marketplace in terms of dollars and consumer interest."

Loren Israelsen President
LDI Group
Salt Lake City, Utah

"The new ruling will have three main effects on a retailer. First, it is going to increase the amount of information the retailer can legally give to a consumer about the actions of dietary supplements in the body. Second, it is going to increase the overlap between OTC drugs and dietary supplements; there are at least 12 categories of claims—including general pain claims and digestion claims—now permissible that were not legal before. Third, it will increase the availability of products to the retailer, because what previously would have been considered therapeutic areas are now structure/function areas."

Scott Bass Partner
Sidley & Austin law firm
Washington, D.C.

Overall, this is a positive step since it expands structure/function claims for dietary supplements' into categories that were previously exclusive to OTCs, such as digestive aids. While the agency back-pedaled on pregnancy claims, it has provided more clarity on its definition of disease states. For instance, it appears to allow claims relating to other natural conditions such as menopause. However, this is likely to be an evolving process that will require continued monitoring by both manufacturers and industry associations."

Dennis O'Donnell
Executive VP and General Manager
Solgar Vitamin and Herb
Leonia, N.J.

More confusion will be created by the new regulations for both the shopkeeper and the consumer. It's still not easy to clearly understand what a "disease" is and what a "health condition" is—and what they are not.

I have concerns about how the expansion of allowed label claims may affect my customers. They may rely on the information provided by the broader label claims and not take the time to get clarification by a person working in the store when it may not be the most appropriate product. And, if the claims go too far, people may self-diagnose and not seek the advice of a medical doctor."

Lisa Blinderman President
Second Nature Markets
East Hampton, N.Y.

More information will be available to consumers, and that's really important. Consumers will be able to make better-informed choices for their particular health challenge. It will help the retailer to more fully explain these products' benefits.

"I do think it is good that there is regulation. There are companies borrowing research and stretching it to conclude things that may not necessarily be right. Yet, while there's a lot of hype out there, there are companies that have done their research and should be able to put product information on their labels."

Wendy Ehrhard Vitamin Manager
Nature's Pantry
Bellevue, Wash.