FEDERAL FOOD, DRUG, AND COSMETIC ACT

Bills and resolutions

Agriculture: prohibit Federal interference in interstate traffic of unpasteurized milk and milk products in final package form for human consumption between States that allow sale of such products (see H.R. 7880), H2476 [9MR]

Diseases and disorders: regulate human cadaveric islets for transplantation as organs (see H.R. 8018), H2621 [19MR]

Drugs: mitigate effects of coronavirus pandemic on incentives for development of orphan drugs (see H.R. 7693), H2327 [25FE]

FDA: amend treatment of homeopathic drug products (see H.R. 7050), H892 [14JA]

——— clarify and affirm preemptive authority over dietary supplement regulation (see H.R. 7366), H2030 [4FE]

——— enhance ability of outsourcing facilities to mitigate drug shortages by allowing short-term period to continue supplying market after drug is in shortage (see H.R. 7528), H2217 [12FE]

——— establish new prohibited acts relative to dietary supplements (see S. 3797), S509 [5FE] (see H.R. 7407), H2041 [5FE]

——— establish standardized pathogen and microorganism testing of infant formula products and manufacturing facilities and mandate notification of specific positive tests and inspection classifications (see H.R. 7867), H2475 [9MR]

——— expand certain authorities relative to recall of controlled substances to apply to all drugs (see H.R. 7980), H2596 [18MR]

——— improve regulation of abortion drugs by prohibiting approval of new drugs, preventing labeling changes of existing drugs, and limiting dispensing of drugs remotely, by mail, or telemedicine (see S. 3697), S290 [27JA]

——— provide for regulation of cannabinoid hemp products (see H.R. 7212), H1349 [22JA]

——— require drug labeling to include original manufacturer and supply chain information (see S. 3788), S509 [5FE]

——— require manufacturers of dietary supplements to list dietary supplements (see S. 3677), S257 [15JA]

——— set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions (see S. 3716), S344 [28JA]

——— specify that food shall be considered misbranded if value of nutrients on its labeling deviates by more than 5 percent of value specified on such labeling (see H.R. 7122), H920 [15JA]

——— specify that hair straightening or smoothing products containing formaldehyde or formaldehyde releasing substances will be considered adulterated (see H.R. 7685), H2327 [25FE]

——— strengthen regulation of compounding pharmacies and outsourcing facilities (see S. 3794), S509 [5FE]

——— withdraw approval of mifepristone for termination of intrauterine pregnancy (see S. 4066), S1009 [11MR] (see H.R. 7902), H2481 [12MR]

NIH: establish National Institute for Biomedical Research and Development (see H.R. 7854), H2471 [5MR]

Tobacco products: clarify FDA jurisdiction over certain tobacco products and protect jobs and small businesses involved in sale, manufacturing, and distribution of cigars (see S. 3922), S681 [25FE]

Remarks in House

NIH: establish National Institute for Biomedical Research and Development (H.R. 7854), H2556 [18MR]

Remarks in Senate

FDA: improve regulation of abortion drugs by prohibiting approval of new drugs, preventing labeling changes of existing drugs, and limiting dispensing of drugs remotely, by mail, or telemedicine (S. 3697), S292 [27JA]

Texts of

S. 3677, Dietary Supplement Listing Act, S259 [15JA]

S. 3797, Prohibiting Tianeptine and Other Dangerous Products Act, S512 [5FE]