The Puerto Rico Secretary of Health, Ana Ríus Armendáriz, MD, announced this week that the Department of Health will not enforce Administrative Order (AO) 346 at this time. The order required product registrations and the payment of fees before dietary supplements could be marketed in the commonwealth. Armendáriz said she will now go through the more normal channels of notice, including a hearing, followed by a comment and rule making period later this year.
CRN took local tack; NPA worked on problem at home
The Council for Responsible Nutrition and the Natural Products Association are both taking credit for the outcome. In CRN’s case, Mike Greene, vice president of government relations, has spent a significant amount of time in Puerto Rico communicating with state officials, with members of the supplement industry there and with the local chamber of commerce. NPA chose to apply pressure in Washington. According to NPA, an article that ran yesterday in the Puerto Rican newspaper El Vocero De Puerto Rico indicated that provisions in PROMESA ultimately forced the Secretary to delay the onerous restrictions on the dietary supplement industry. PROMESA is the debt restructuring package for Puerto Rico that was negotiated in the halls of the US Congress.
Greene spoke with NutraIngredients-USA from a hotel in San Juan that was running on a generator because of the failure of a power generation plant. He said the message resonated that the commonwealth has more pressing concerns than trying to squeeze a successful industry for fee revenue at a time when the local economy is at a low ebb and the infrastructure is in shambles. The rolling blackouts that have afflicted San Juan have only served to emphasize that message, he said.
“I think this is a victory on many levels,” Greene said. “The articles that ran in the local press were raising concerns about why the Secretary did this at this time, when the government should be looking to reward entrepreneurship.”
“This wasn’t just CRN. This was also the result of efforts by the local chamber of commerce, retail groups and big retailers like Walgreens and Walmart,” he said.
Still no reason why
One view of the administrative order was that it was 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 in within the commonwealth. But Greene said no one can really be sure what the base motivation for the order was, because the Secretary has yet to make that fully clear.
“Everybody has been asking that question. We wanted to find out where it came from. If there really are problems with the industry in Puerto Rico we would want to know about them so that we could help to fix them. We want the consumers in Puerto Rico to be happy with the products they are taking. We’ve had a number of good meetings with the Secretary’s staff, but we are still waiting to find out why,” Greene said.
Assuming the rule making procedure does go forward, it can be expected that Armendáriz would have to lay out her reasons for requiring this registration and fee structure, which would be the only one of its kind in the US.