FDA embarks on new enforcement strategy

FDA embarks on new enforcement strategy

In brief, it’s been an interesting and active past 10 days for the two major regulatory agencies affecting the natural products industry: the U.S. Food and Drug Administration and the Federal Trade Commission.

At the FDA:
Recently, the FDA issued a new enforcement strategy, to begin on Sept. 15, that will provide an incentive for companies to respond promptly to inspection reports (form 483), in a program intended to “facilitate the timely issuance of warning letters and promote prompt corrections of violations.

Also recently, the FDA has proposed a rule that would require electronic filing of AER reports for drugs. While this requirement may be extended to over-the-counter drugs, it would not apply to Adverse Event Reports for dietary supplements, though many stakeholders have expressed a desire for an electronic system.

In a general administrative reorganization and restructuring, the FDA has elevated the Office of Foods to a higher level (reporting directly to the Commissioner), which will strengthen the Agency’s focus on scientific research and food safety.

Speaking of science, the FDA has recently decided to reevaluate the potential risks of low exposure to BPA in plastics.

A new lawsuit may compel the FDA in the future to also reassess its rejection of a proposed health claim that would link the antioxidants Vitamins C and E to a reduced risk of certain cancers.

In another recent lawsuit, a federal court reinforced an earlier ruling that FDA warning letters and similar Agency actions did not have the force of a federal regulation – in this case, thereby concluding that certain claims of “natural” for foods were legal, in part because FDA had declined to officially define “natural” and because there has been no formal rulemaking process on what “natural” claims mean.

At the FTC:
During a very litigious past few weeks, the FTC first suffered a significant defeat, and later won a large victory. The supplement company LaneLabs prevailed over the FTC in a federal district court, successfully showing that it did indeed have solid scientific substantiation to support its efficacy claims. The judge called the dispute a “battle of the experts” and concluded that the Commission had failed to make a convincing case in its critique of the company’s scientific studies, including some peer-reviewed trials.

In perhaps the largest FTC fine ever imposed, a federal district court has ordered the marketers of two dietary supplements, "Supreme Greens" and "Coral Calcium," to pay nearly $70 million for deceiving consumers about these supplements’ effectiveness and safety. The claims were that the products could cure ailments such as cancer, Parkinson’s disease, heart disease, and autoimmune diseases.

In addition, besides citing violations relating to an infomercial, the FTC also objected to the marketers making unauthorized credit and debit charges for consumer sales.

In a very important development affecting telemarketers, the FTC on Aug. 27 banned prerecorded calls (or “robocalls”), effective Sept. 1—absent written permission from a customer. The fine for violations will be $16,000 per call.

On the lighter side:
A news piece reported that a very health-conscious Florida doctor was forced to resign because he tried to be the Nutrition Police, for example putting up office signs such as "Doughnuts = Diabetes." He also banished all sweets and sodas from the break room and the vending machines, but the employees rebelled!

Compiled by Susan D. Brienza, Esq. (Patton Boggs LLP). For questions, comments, or further information, please write [email protected]

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