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 Northern District of California recently applied the Ninth Circuit’s ingredients list rule in a putative class action decision. The Court refused to grant Nestlé USA Inc.’s summary judgment motion based on the statute of limitations in a suit involving allegations that Nestlé misleads consumers about the trans-fat content of their Coffee Mate creamer products. The Court held that a triable issue of fact remained because it was not clear when the consumer first learned about the alleged deception.