Puerto Rico Supplement Rule Still Percolates: Health And Wellness Industry News Roundup

The Council for Responsible Nutrition wants Congress to know that dietary supplement retailers and distributors in Puerto Rico still could be subject extensive fees and regulations should the commonwealth approve a proposal put on hold recently. In comments to the Congressional Task Force on Economic Growth in Puerto Rico, CRN explains that Puerto Rico's Department of Health will take another shot, through a rulemaking process, at implementing Administrative Order 346 to require a $25 per-SKU, per-store registration fee, and registration fees every two years of $500 for manufacturers and $100 for product distributors. Under pressure from commonwealth lawmakers, the Health agency in September suspended enforcement of AO 346 and said that later this year it will conduct a rulemaking with notice of a proposal, following by a hearing and a comment period; the agency had proposed the rule without notice and intended to impose it even without lawmakers' approval of authorizing legislation. (Also see "Puerto Rico's Supplement Registration Proposal Moved To Rulemaking Process" - HBW Insight, 23 September, 2016.)

The agency's "decision does not end this matter or relieve the citizens of Puerto Rico of the potential for limitations on their access to a wide range of lawful dietary supplements," said Ingrid Lebert, CRN's government relation director, in the Oct. 14 comments. She adds that AO 346 does not recognize that supplements are regulated as a category of food in the US. While Puerto Rico's pharmaceutical regulations require all drugs, OTCs and medical devices sold there to be registered with the Health agency, the agency "makes the erroneous assumption that dietary supplement products are in the same regulatory category as prescription and OTC drugs