The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule will go into effect on September 1, 2021.
The new rule may provide an end to a years-long process on knowledge-based labeling directives in the old regulations. Proposed amendments to clarify the “intended use” regulations began in 2015, which we discussed previously.
The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction to block the FDA from withdrawing a longstanding enforcement policy regarding homeopathic drug products.
The U.S. Consumer Product Safety Commission (CPSC) and Peloton Interactive, Inc. (Peloton) are clashing over whether the media, technology, and fitness company should issue a recall of its treadmill, the Peloton Tread+. The disagreement came to a head on Saturday, April 17, when the CPSC and Peloton issued competing statements after failing to agree on language to be used in a joint announcement regarding the Tread+. This dispute raises the question, “What now?”