FDA reform bill adopted Nov. 9 preserves states' safety authority over cosmetics.
This article was originally published in The Rose Sheet
Executive Summary
FDA COSMETICS-DRUGS RECORDS INSPECTION AUTHORITY GRANTED IN REFORM BILL in a provision that expands the agency's records inspection jurisdiction to over-the-counter drugs. "Cosmetic products that are also OTC drugs will...be subject to records inspection by FDA," according to a Senate/House conference committee statement released Nov. 9 after passage of the FDA reform bill by both chambers. The clause amends the Good Manufacturing Procedures (GMP) provision in the FD&C Act that authorizes the agency to inspect the manufacturing facility records of prescription drug manufacturers. Cosmetic-drug products that will be required to comply with the records inspection clause include sunscreens, acne products, dandruff shampoos and antiperspirant/deodorants.
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OTC records inspection
Cosmetic-drug products, including sunscreens, acne products, dandrushampoos and antiperspirant/deodorants, will be required to comply with the new OTC records inspection provision of the FDA Modernization Act. Industry concerns regarding implementation of FDAMA's new OTC records inspection provisions were raised at an "exploratory" meeting between FDA and the Consumer Healthcare Products Association Sept. 15. Agency inspection of OTC company records is likely to begin only after FDA has provided "sufficient time and guidance" to industry, according to a Senate/House conference statement released in conjunction with passage of the bill (1"The Rose Sheet" Nov. 17, 1997, p. 1)
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