This was forwarded to us regarding another companies dealings with FTC / FDA regulations on free speech.

A few months ago, we notified you that the Federal Trade Commission (“FTC” or “Commission”) intended to change its standard for “competent and reliable scientific evidence” as it applies to claims for over-the-counter (“OTC”) drugs, dietary supplements and functional foods, starting by imposing the new standard on individual companies through consent decrees. Now, as predicted, the FTC has introduced that new standard into consent decrees with Iovate Health Sciences, Inc. (“Iovate”) and Nestle HealthCare Nutrition, Inc. (“Nestle”).

Specifically, yesterday’s FTC consent decree with Iovate Health Sciences imposed a provision under which Iovate is barred from representing that its products cause weight loss or rapid weight loss unless the claims are truthful and backed by “competent and reliable scientific evidence” in the form of:

1.    At least two adequate and well-controlled human clinical studies,
2.    of the product at issue or an essentially equivalent product
3.    conducted by different experts independently of each other,
4.    that conform to acceptable designs and protocols and whose results, when
considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate the claim.

The FTC defines an “essentially equivalent product” as a product that contains the identical ingredients, except for inactive ingredients (e.g., inactive binders, flavors, preservatives, colors, fillers, excipients), in the same form and dosage, and with the same route of administration...provided that the covered product may contain additional ingredients if reliable scientific evidence generally accepted by experts in the field demonstrates that the amount and combination of additional ingredients is unlikely to impede or inhibit the effectiveness of the ingredients in the essentially equivalent product.

The FTC’s agreement with Nestle HealthCare Nutrition, Inc. imposes the same substantiation requirement on the company for claims that its product “Reduces the duration of acute diarrhea in children up to the age of thirteen,” or “Reduces absences from daycare or school due to illness.”

As you know, the FTC requires that all marketing claims for dietary supplement and functional food products be supported by “competent and reliable scientific evidence.” While these two consent decrees only apply the new standard to specific types of claims, it is likely that the Commission will attempt to impose that standard more broadly over time. If the Commission succeeds in applying its new standard to the dietary supplement and functional food industry as a whole, it will place a significantly increased substantiation burden on marketers.

Moreover, the Iovate consent decree prohibits that company from making disease-related claims for drug or dietary supplement products unless the claims are non-misleading and the products (1) are subject to a final OTC drug monograph promulgated by the Food and Drug Administration (“FDA”) for the claimed use, and conform to that use; (2) remain covered by a tentative final OTC drug monograph for the claimed use and adopt the conditions of such use; or (3) are the subject of a new drug application for the claimed use that has been approved by FDA. Importantly, that language does not seem to contemplate FDA-approved health claims for dietary supplements. In addition, homeopathic drugs are not exempt from the prohibition on disease claims without FDA approval or monograph compliance, which is inconsistent with the way those products are currently treated by FDA.

If you have questions or concerns about the FTC's new standard for competent and reliable scientific evidence, contact Claudia A. Lewis, at 202.344.4359, calewis- eng@venable.com, or Todd A. Harrison, at 202.344.4724, taharrison@venable.com.

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