Canada sets probiotic labeling deadline
This article was originally published in The Tan Sheet
Executive SummaryProbiotic product claims must comply by April 2010 with guidance Health Canada approved in April, which the Canadian Food Inspection Agency recently added to its rules. In an Oct. 1 letter to industry, CFIA's Food Safety and Consumer Protection Directorate advised that labels, advertisements and Web sites must comply with the probiotic labeling guidance within six months. The Guide to Food Labeling and Advertising distinguishes between strain-specific and general claims. Health Canada prohibits misleading or vague claims, and science directly applicable to a particular food must support strain-specific claims. The agency noted no specific strains have been accepted, but it will update its online list of strain-specific claims as they are reviewed and accepted
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.