The War Against
Non-Drugs
July 1998 -- Regulatory Insight
By: Gerry Clark
Genuine drug or pretender to the throne? Thwarting a blurring of the two is the aim of an FDA proposed rule targeting dietary supplement claims.
The essence of the agency's recent move isn't entirely new. Back in 1994, the Dietary Supplement Health and Education Act (DSHEA) set out to distinguish between allowable and prohibited claims. The FDA's recent proposal, "Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body," seeks to further clarify the distinction. Though the measure might seem, at first glance, applicable to only products in pill form, food-like products such as health bars and beverages also fall under DSHEA's umbrella.
"There are some gray areas or arguable points," FDA spokesman Arthur Whitmore says of the current situation. "Setting it out in black and white, and putting it in a proposed-rule setting cannot help but clarify the situation."
The proposal, published in the April 29 Federal Register, provides examples of nomenclature or statements that fall on either side of the legal line. Prohibited claims include: "protects against the development of cancer" and "reduces the pain and stiffness associated with arthritis." These would be forbidden because they imply or state a product has an effect on a specific disease. Likewise, supplements cannot be referred to as belonging to a specific drug class, such as "antibiotic," "antidepressant" or "laxative."
The agency's proposed language regarding cholesterol, in particular, has raised the concern of some groups, who believe the measure does little more than split hairs. Under the proposal, FDA would allow claims stating that a product helps maintain healthful cholesterol levels, but would prevent the statement "lowers cholesterol."
"More people die of heart disease in this country than anything else," says David Schardt, associate nutritionist, the Center for Science in the Public Interest (CSPI), Washington D.C. "We're concerned that some people will think they can self-medicate themselves with some of these supplements."
The Council for Responsible Nutrition (CRN), a Washington, D.C.-based organization representing supplement manufacturers, believes both cholesterol statements should be permissible, but says a further clarification of the proposal's overall language needs to occur. "A large number of examples they've given are related to heart disease or cholesterol," says Annette Dickinson, Ph.D., director, scientific and regulatory affairs, CRN. "I think those are the grayest areas. In other areas, I think they've been reasonable, such as claims regarding maintaining immunity."
FDA has concentrated on actual applications, Whitmore says, with the proposed rules stemming from past encounters with products. "It's a real situation we're dealing with," he explains. "In the view of lay people or some industry people, it may, at first, appear to be a quibble, but in fact it's not.
"Regarding cholesterol, our position is: Maintenance is allowable, but making a claim about lowering cholesterol is straying into drug territory," Whitmore says. He also emphasizes that the agency is looking at the larger picture, not just isolated phrases, when it comes to product labels. "Each product and label has to be evaluated on a case-by-case basis. You look at the whole label and see what the message is that's being communicated."
Although FDA's move was instigated by recommendations contained in a recent report from the Commission on Dietary Supplement Labels, some speculate that the agency also desires to pull together the decisions it has been making on a piecemeal basis. Since DSHEA was passed, FDA has received roughly 2,300 notifications from manufacturers, the agency reports. FDA has told manufacturers that approximately 150 of these are "problematic" and estimates an additional 60 claims would be prohibited under the proposed rules.
Several organizations say that, for the most part, the parameters simply clarify what's already on the books with DSHEA, and they don't wholesale object to them.
"We're not Johnny-come-lately to label claims, so we know what's allowable and what's appropriate," says Gregory Miller, spokesman for retail chain General Nutrition Centers, Pittsburgh. "DSHEA is pretty clear on what you can do. It's not an unregulated industry by any means."
Celestial Seasonings, Inc., the Boulder, CO-based herbal tea, beverage and supplement manufacturer, is pleased FDA has decided to take this step. "We think it's a good proposal," says Kerin Franklin, director, R&D, Celestial Seasonings, "because it comes out and says: 'These are the kinds of claims that are allowable and these are the kinds of claims that are not.' We see it as a really positive step forward."
The company believes the public currently faces a confusing scenario and FDA's move will help clear up the situation. "I think consumers, as a whole, are a very captive audience right now," Franklin says. "They want to learn. There are some companies that are stretching it a bit far. Some want to jump on the bandwagon and make a lot of money. But you'll see that the leaders in the industry will be the ones who act ethically."
CSPI, on the other hand, has come down hard on the proposal, claiming "Congress has tied (FDA's) hands" by requiring the agency to allow dietary supplement companies to make unsubstantiated claims.
"Congress has basically given the supplement industry wide latitude and there's little review of that by FDA," Schardt says. "They still allow companies to put out label claims without support of scientific evidence.
"Companies are allowed to put things on labels that aren't true," he says. "One example is Gingko biloba. There is no evidence that in normal, healthy people, Gingko biloba improves memory."
CSPI doesn't view FDA's proposed rules as making much of an impact. "We knew that FDA had to do something, because some companies are advertising their supplements as drugs, and confusing the public," Schardt says. "But we don't see the situation changing much, because companies are getting good at creating labels that stay on just this side of the law. Already, companies are learning how to finesse the labels."
Whitmore disagrees, stating that the proposed rules will help manufacturer and consumer alike. Also, the current legal climate already provides protections: "You cannot make an unsubstantiated drug claim in U.S. commerce without breaking a federal law."
Concerned parties can file remarks with FDA during the 120-day comment period. Whitmore predicts the rules will be finalized and enforceable either by late 1998 or early 1999.
If the proposal is finalized, unacceptable structure/function claims would have to be removed from labeling, according to FDA, or a product would have to be approved as a drug under the Federal Food, Drug and Cosmetic Act.
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