FDA Narrowed "Disease" Definition Expands Structure/Function Claims
This article was originally published in The Tan Sheet
Executive Summary
Dietary supplement manufacturers will be able to make expanded structure/function claims on product labeling under an FDA final rule published in the Jan. 6 Federal Register. The rule clarifies the distinction between structure/function and disease claims by reverting to the older, narrower definition of "disease" used in the Nutrition Labeling & Education Act.
You may also be interested in...
CFSAN 10-Year Dietary Supplement Strategy Comprises Six Core Areas
The creation of an advisory committee or "standing group" on dietary supplements is one of the priorities under the FDA Center for Food Safety & Applied Nutrition's 10-year plan for supplement regulation.
Disclaimers May Be "Subterfuge" For Disease Claims, PhRMA Exec Warns
FDA should be cautious in allowing a disclaimer statement that could mislead consumers into believing dietary supplements can cure or prevent disease, a PhRMA rep maintained at FDA's Aug. 4 public meeting on the regulation of supplement structure/ function claims in Washington, D.C.
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC