The Food and Drug Administration has its own version of a "weight loss" program for the dietary supplement industry. An FDA proposal made on April 29 would force supplements, vitamins and herbals to slim down the health claims made on product labels. The agency would also shrink allowable product names and label art. The FDA proposal expands the category of disease remediation claims, which dietary supplements are not allowed to make. On the perimeter of the new boundary would be conditions such as chronic headaches, pre-menstrual cramps and aging ailments such as an enlarged prostate in men. Tony Young, counsel to the American Herbal Products Assn. (AHPA), says, "We think the FDA is trying to expand the disease definition beyond its reasonable limit." Besides expanding the disease category, the FDA would also limit the language and symbols companies use on their labels to imply that a product helps treat or prevent a disease. A company could not, for example, use a tracing of an electrocardiogram or the picture of a body organ. One executive, who did not want to be identified, says his company's 12 herbal products all use graphic icons on their labels. The company's echinacea product, which makes a claim about boosting a person's immune system, uses a graphic of a person coughing with his hand over his mouth. This company executive is not sure whether any or all of the herbal product icons would have to go if the FDA proposal is finalized. With its proposal, the FDA is trying to draw an indelible line between products in the vitamin/mineral section of a grocery or drug store, and those in the over-the-counter medication section. That is why General Nutrition Corp., Pittsburgh, PA, has no problem with the FDA proposal. Its products, sold in its own retail stores, do not have to compete with OTC drugs. Moreover, Greg Miller, the company spokesman, says GNC has taken a conservative approach on labeling, ever since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Seasonal 'flap' Of course, other manufacturers have occasionally tried to push the envelope. Recently the FDA sent "courtesy" letters to about 40 companies telling them to desist in making label claims that their products "are for use during cold and flu season." Monica Revelle, an FDA spokeswoman, acknowledges that the agency did send out the letters informing the companies of the need to change "good for use in cold and flu season" label language. "That is as close to making a drug claim as you can get," she explains, adding that it is too close for the FDA's comfort. Interestingly, the FDA does not address the "cough/cold/flu" claims directly in its proposal. One would have expected the agency to do so when it laid out its objections to "product class names that are so strongly associated with diagnosis, cure, mitigation, treatment or prevention of a disease or diseases, that a claim that a product belonged to such a class would be understood as a disease claim." The agency does say this reasoning would prohibit label terms such as "laxative, analgesic, antiviral, diuretic, antiseptic and others." 'Conditions' could be target The AHPA's Young also expects claims about easing menstruation, menopause, enlarged prostates in men over 50, and sleeplessness to be banned, as well. Those would be included in a banned category of claims that allude to a "characteristic set of signs or symptoms recognizable to health care professionals or consumers as constituting an abnormality of the body, such as toxemia of pregnancy, premenstrual syndrome or abnormalities associated with aging such as decreased sexual function, Alzheimer's disease or hot flashes." He argues that menstruation, for example, is not an "abnormality of the body," and therefore not a disease, but a condition. "We don't believe DHSEA bars claims about conditions which are not recognized as diseases," he explains. However, the FDA proposal would hurt some product classes less than others. Although a product could not call itself a "laxative," it could say it promotes regularity. In other instances, the FDA proposal actually gladdens the hearts of some supplement manufacturers. For example, a product could have as its name "Cardiohealth" or "Heart Tabs." Young says, "Some people in the industry were quite surprised by that, and quite pleased." Watch out for disease Underlying the FDA's approach to the use of label language is its interpretation of DSHEA. That law lets companies make a claim that "describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans." If a company stays within those bounds-and has scientific substantiation-it simply notifies the FDA that it is putting the claim on its product label. under DSHEA FDA's worries when a company makes a claim that its dietary supplement "diagnoses, mitigates, treats, cures or prevents a specific disease or class of diseases." That is a "no-no" . In a nutshell, the FDA has the unenviable job of deciding when, for instance, a claim that a product helps cardiovascular health becomes a claim that a product retards cardiovascular disease. "This can be a difficult distinction conceptually, especially if the only reason for maintaining normal function is to prevent a specific disease or diseases associated with abnormal function," FDA concedes. Under its proposed rule, the FDA would be able to decide that some of the claims allowed today are really "disease" claims and are therefore prohibited. The agency, for example, wants to expand the definition of "disease" to include "health-related conditions." This is intended to rope in problems such as chronic headaches. Moreover, the FDA says the proposal would require it to look at a structure/function claim "in the context in which it appeared." It could become a disease claim if an effect on disease is expressed or implied. An example here might be a claim that a product "reduces the pain and stiffness associated with arthritis" or "decreases the effects of alcohol intoxication." Few objections to DSHEA The FDA says it has received 2괌 notifications since 1994 from dietary supplement companies saying they planned to make a "structure/function" claim on a product label. The FDA objected to 150 of those claims based on the agency's reading of current regulations. However, if the regulations are changed as the FDA is proposing, the agency would have objected to an additional 60 claims. That is an extra 2.5%, not a big number in anyone's book. So on quantitative grounds, the FDA proposal does not appear to be a dagger at the dietary supplement industry's heart. AHPA counsel Tony Young says that a more market-oriented way to analyze the proposal's impact is to look at the number of "facings" that would be affected. The inability of vitamins and herbal products to use the terminology "use during the cold and flu season" on their label would badly hurt products based on echinacea. Stores may have six to 10 facings of echinacea-only products, and additional facings of echinacea-plus-other-ingredient products. Under the FDA proposal, these could continue to say they "help support the immune system." But if the FDA bans allusions to use during the cold/flu season and kills icons such as the palm-to-the- mouth, echinacea facings may face some problems.
