Some OTC drug monograph claims may be acceptable dietary supplement structure/function claims, FDA concludes in the final rule on supplement claims criteria published in the Jan. 6 Federal Register. However, others would be disease claims if used on supplement products, the agency adds.

The issue was raised in comments submitted to FDA in response to the proposed rule on structure/function claims. One comment offered a list of drug claims from the OTC monographs for antacids, antiflatulents, antiemetics, nighttime sleep-aids, stimulants, daytime sedatives, aphrodisiacs, anticholinergics and "products for certain uses."

Two comments asked for clarification on whether a claim included in an OTC monograph is precluded from use as a structure/function claim.

Of the antacids monograph claims, "Relief of sour stomach" and "Upset stomach" are acceptable structure/function claims "because they refer to a nonspecific group of conditions that have a variety of causes, many of which are not disease-related," FDA says in the final rule.

"Although 'Relief of heartburn' and 'Relief of acid indigestion' without further qualification are not appropriate structure/function claims, the agency concludes 'Occasional heartburn' and 'Occasional acid indigestion' can also be considered nonspecific symptoms, arising as they do in overindulgence and other specific situations," and thus could be used as structure/function claims.

"In contrast," the final rule continues, "'recurrent' or 'persistent' heartburn and acid indigestion could be hallmarks of significant illness, and are therefore disease claims."

All of the antiflatulents monograph claims are acceptable because the symptoms cited are not characteristic of specific diseases, FDA states. The claims include: "Alleviates the symptoms referred to as gas"; "Alleviates bloating"; "Alleviates pressure"; "Alleviates fullness" and "Alleviates stuffed feeling."

The claim listed from the antiemetics monograph - "For the prevention and treatment of the nausea, vomiting or dizziness associated with motion" - also is a permitted dietary supplement claim.

The nighttime sleep aids monograph claim "For the relief of occasional sleeplessness" is allowed, but "Helps you fall asleep if you have difficulty falling asleep" and "Helps to reduce difficulty falling asleep" are disease claims because they imply treatment of insomnia.

The stimulants monograph claim listed - "Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness" - also is approved in the rule.

Almost all of the claims listed from the daytime sedatives monograph are permitted as structure/function claims as well.

"Occasional simple nervous tension," "Nervousness due to common every day overwork and fatigue," "A relaxed feeling," "Calming down and relaxing," "Gently soothe away the tension," "Calmative," "Resolving the irritability that ruins your day," "Helps you relax," "Restlessness," "Nervous irritability" and "When you're under occasional stress, helps you work relaxed" are suitable claims because they suggest occasional rather than long-term or chronic mood changes, FDA says. However, "Nervous tension headache" is a disease claim.

Of the claims from the aphrodisiacs monograph, "Arouses or increases sexual desire and improves sexual performance" is acceptable, but "Helps restore sexual vigor, potency and performance," "Improves performance, staying power and sexual potency" and "Builds virility and sexual potency" are disease claims, suggesting treatment of impotence, FDA says.

However, if the claims clarified they were intended solely for decreased sexual function related to aging, they would be allowed, the agency adds.

The claim listed from the anticholinergics monograph, "Relieve excessive secretions of the nose and eyes," is a disease claim referring to hay fever, the rule says.

From the "products for certain uses" monograph, "Digestive aid," "Stool softener," "Weight control," and "Menstrual" are by themselves satisfactory as structure/function claims, but "Nasal decongestant," "Expectorant" and "Bronchodilator" are disease claims, according to the rule.

As made clear from its responses to the specific claims, FDA agrees inclusion of a claim in an OTC monograph does not prevent its use as a structure/function claim, the rule notes.

"In light of the statutory requirement that dietary supplements bear all information that is material in light of consequences that may result from use of the product or representations made about it, dietary supplements that contain or are labeled as containing ingredients covered by an OTC monograph and that are being sold for the claims covered by the monograph may be misbranded to the extent that they omit material information required under the monograph," the rule explains.

FDA reiterates there are a "large number" of marketed supplement products making claims for which the agency has not received 30-day notification letters. As of the final rule's Jan. 6 publication, FDA had received approximately 4,350 structure/function claim notifications and sent out over 300 "courtesy" letters.

The rule says the dietary supplement industry markets approximately 29,000 covered products with about 75,000 distinct labels. FDA believes the percentage of dietary supplement products bearing structure/function claims "would not exceed 60%."

FDA surmises the final rule may require revised labels for about 4.81% of the 17,400 dietary supplement products (29,000 x 60%) estimated as marketed with structure/function claims. Excluding cholesterol claims, the figure would only be 1.74% of products with claims, the agency maintains.

The total direct costs of compliance with the final rule are estimated to be $3.7 mil., with sensitivity analysis data showing costs could rise to as high as $10.3 mil. under "certain worse-case assumptions."

In the proposed rule, the agency had estimated direct costs of compliance ranging from $100,000 to $8.5 mil. Several industry comments on the proposal had contended FDA underestimated the costs of relabeling.

Certain OTC Drug Monograph Claims May Be Structure/Function Claims - FDA

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