Counselor's Corner

Q: May aphrodisiacs be marketed and sold as dietary supplements?

A: Food and drug law does not preclude aphrodisiac and sexual enhancement products from being sold as dietary supplements, provided the label claims, labeling (brochures, package inserts) and promotional materials comply with the Dietary Supplement Health and Education Act and all applicable Food and Drug Administration and Federal Trade Commission regulations.

For example, a company may claim a sexual performance product affects the structure or function of the body in terms of increased sexual energy, enhanced sexual function or arousal. However, it would not be permissible to claim a positive effect (such as improved vigor) on impotence, erectile dysfunction or other sex-related abnormalities. Moreover, such a disallowed claim may not be implied in a product name—"Herbal Viagra," for example. It is also impermissible for a company to claim a dietary supplement treats, cures, mitigates or prevents a sexually transmitted disease.

Q: What level of substantiation is required for claims about breast enhancement for dietary supplements?

A: A company making breast-enhancement claims must possess credible scientific evidence for every express and implied structure/function claim. If, for example, the label or other labeling contains an express or implied claim that the product will enlarge the breasts, the company must have scientific evidence to support the assertion that the product, when taken as directed on the label, actually helps to enlarge the breasts.

The level of substantiation for breast enhancement claims is the same as is applied to all structure/function claims. The FTC standard for substantiation is competent and reliable scientific evidence. While the FDA has not specifically defined "substantiation" or stated how much evidence is required, in general, it has said that structure/ function claims "should be supported by adequate scientific evidence." The FDA does not require the substantiating studies to have been performed using the actual marketed formulation. However, the FDA has directed companies making structure/ function claims that, before they use a study to substantiate a structure/function claim made for a particular product, they consider the differences between the formulation used in the study and the formulation of the marketed product. Finally, given that there is some evidence that the herbal ingredients of these breast enhancement products may cause drug interactions, appropriate warnings should appear on the label, based on the recommendations of the company's formulator and medical adviser.

Q: In general, may evidence of traditional use serve as substantiation for structure/function claims under Section 6 of DSHEA?

A: Evidence of traditional use must be supported by "adequate scientific evidence." On its own, traditional use is not sufficient to substantiate a structure/function claim. However, many of the herbs that are used in sexual enhancement or women's products, such as saw palmetto, black cohosh and dong quai, have been the subjects of clinical trials, either in the United States or in other countries. A thorough search of the scientific literature is necessary; the company's own study or trial is not necessary. The company responsible for the structure/function claims must have adequate scientific substantiation in its files, and must submit to the FDA a Section 6 Notification (for Section 6 of DSHEA) within 30 days post-market, confirming that the claims are true, accurate and not misleading and that substantiation is available.

Q: What types of claims are permissible for a dietary supplement addressing the discomforts of premenstrual syndrome and menopause?

A: One of the significant changes between the FDA's Proposed Rule on structure/function claims for dietary supplements and its Final Rule of Jan. 6, 2000, was the liberalization of the agency's stance on claims about the symptoms and discomforts of menopause and PMS. Since PMS is a common problem for many women and menopause is a common stage of life for most women, the FDA does not classify these conditions as diseases. Thus, structure/function statements about the effect of a dietary supplement on the normal conditions associated with PMS and menopause are permitted.

For example, a label or advertisement may claim that the product alleviates mild mood swings, periodic cramps, night sweats, hot flashes, mild swelling, bloating, breast tenderness, irritability or mild sleep disturbances. In addition, a company could claim a supplement supports a "healthy attitude" or evenness of moods during PMS or menopause. However, a dietary supplement may not claim to treat or address insomnia, serious anxiety or depression.

It is significant to note that the FDA did not change its position on supplements for the male condition benign prostate hypertrophy. Even though many mature men experience this condition, the FDA considers it a disease, presumably because BPH is not as automatic as is menopause. Thus, explicit and implied claims about products or ingredients addressing BPH are disease claims.

Q: May a dietary supplement for menopause be sold as an alternative to estrogen or hormone replacement therapy?

A: No, the Final Rule prohibits claims that suggest a dietary supplement can be used as an alternative to a drug. In general, the FDA's position is that if a product is labeled or advertised as a drug alternative, it is considered a drug. In addition, there should be no explicit or implied references in either labeling or promotional material to preventing or lowering of the risk of breast cancer or other conditions that might require an HRT alternative.

Here and elsewhere, my answer refers to advertisements as well as labels, and the reason for this is the principle of "intended use." The FDA may legitimately examine any and all materials related to a dietary supplement to determine whether it is intended to be used as a supplement or as a drug. Although the FDA primarily regulates labels and the FTC primarily regulates ads, keep in mind that the FDA and the FTC have shared jurisdiction. In a recent case, when a Web site address was printed on a food label, the FDA visited the company's Web site (arguing that the cross-reference made the site content labeling) and examined it for regulatory compliance.

Q: What about candida yeast products—are these drugs or dietary supplements?

A: Technically, a claim to maintain healthy levels of candida yeast is a permissible structure/function claim. In the past, the FDA has taken the position in "courtesy letters" that reference to candida yeast, even in this manner, is an implied claim to treat yeast infection, which is a disease as the FDA defines that term. On the other hand, in the preamble to the Proposed Rule and Final Rule on structure/function claims, the FDA used as examples of permissible claims statements such as: "promotes healthy digestive system" or "maintains healthy intestinal flora." Claims about levels of yeast, as with all structure/function claims, are interpreted in the context of the label as a whole, a concept that the FDA repeats approximately 30 times in its commentary on the Final Rule.

Q: Are there particular FTC issues about advertisements designed for sexual health and performance?

A: Sexual health and sexual enhancement products do not seem to be a top priority for FTC enforcement. However, as with any advertisements for dietary supplements, it is prudent to avoid certain red flags, such as "all natural," "safe" and "proven." The claim of "safe" may not be used lightly when no or inadequate safety studies have been performed. "Proven" conveys to the reasonable consumer that human clinical trials have been conducted—meaning placebo-controlled, double-blind studies, usually at a university. If only animal studies have been performed, or only preliminary results have been obtained about an effect, then the word "proven" is misleading or deceptive.

Marketers and promoters of breast-enhancement products must be especially careful. Sometimes the effect may be only subjective, or documented with only subjective data or testimonials, such as a woman "feeling fuller." In addition, under FTC law, if only a few women in a study or survey have increased from an A cup to a C cup, then an ad promising "Increase two cup sizes" is misleading, possibly deceptive and must be accompanied by a clear and prominent disclaimer that the typical result is X. In addition, if the breast-enlargement effect is temporary, then this fact must be disclosed on both label claims and ad claims. Finally, for the reasons presented in earlier answers, a breast-enhancement dietary supplement product may not be promoted as "an alternative to cosmetic surgery."

Susan D. Brienza is an attorney in the Denver office of the Washington, D.C., law firm Patton Boggs LLP. She practices in the area of regulatory compliance, FDA law (including DSHEA) and FTC law. If you have a question, e-mail her at [email protected].

Natural Foods Merchandiser volume XXII/number 11/p. 28, 32-33