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SDS Requirements for FDA Products

Products regulated by the US Food & Drug Administration are exempt from OSHA workplace labeling requirements (29 CFR 1910.1200(b)(5)(iii)) if those products are regulated by the Federal Food, Drug, and Cosmetic Act (21 CFR 301) or the Virus-Serum-Toxin Act of 1913 (21 CFR 151).

Food, drug, and cosmetic products have to follow different regulations for labeling but these products are still legally required to have an appropriate Safety Data Sheet if they pose a chemical hazard to the end-user. 

Who regulates SDSs for FDA products? As long as the chemical mixture poses a hazard then OSHA regulates the Safety Data Sheet in accordance with the Hazard Communication Standard (29 CFR 1910.1200).

FDA products have a universally recognized labeling format which doesn’t have the same signal words, pictograms, or required phrases required by OSHA.

There will be a difference between a Drug Facts Label and the required labeling information found on the Safety Data Sheet but the good news here is that both the FDA and OSHA exempt the labeling requirements if a product is regulated by one agency over the other. 

In other words: OSHA SDSs are different from FDA labeling but an FDA regulated product will still require an OSHA compliant Safety Data Sheet.

Food, food products, alcoholic beverages, and food intended for personal consumption do not require an OSHA compliant SDS.

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