Early last year, a move was announced by the commonwealth government to specifically regulate dietary supplements. Companies wanting to sell products there would have to apply for a certification from the commonwealth government.
Registration requirement dates back to 2016
Trade organizations, including the Council for Responsible Nutrition and the Natural Products Association, objected to the requirement in 2016 when it was first put forward in the form of an administrative order under then Secretary of Health Ana Ríus Armendáriz. The groups noted it added an unnecessary level of bureaucracy and did nothing to further protect consumers in the state. Rather, it was seen primarily as an attempt to collect a new slate of fees.
The trade organizations also objected on the basis that dietary supplements are regulated at the federal level. Thus, the primary regulatory body is the Food and Drug Administration, and additional state-level regulations are inappropriate.
Before the New Year, CRN announced that Puerto Rico Governor Ricardo Antonio Rosselló Nevares signed into law a bill designated as PC 1034.
The new law states that dietary supplement companies that are already required to register under FSMA and Bioterrorism Act provisions will be exempt from complying with the commonwealth’s own registration requirements. While that requirement remains on the books as Regulation 9031, the law signed in late December means that for all intents and purposes, for the dietary supplement industry it has become a dead letter.
“Moving forward, CRN will engage with the PR Department of State and PR Department of Health to guarantee changes to (or the revocation of) Regulation 9031,” CRN said in a press release.
Reasons for registration requirement remain murky
One view of that regulation is that it is a transparent effort to generate fee revenue from a thriving industry to help to refill state coffers drained from years of maintaining high state staffing levels during a period of sharply declining tax collections.
Another possible reason was a perceived need to weed out bad actors who were selling poor quality products within the commonwealth. When Armendáriz first proposed the administrative order in 2016, CRN said at the time she gave no reason as to why it was necessary. PC 1034 includes no preamble stating the reasons for the new regulation.