The Puerto Rico Secretary of Health, Ana Ríus Armendáriz, MD, announced that the Department of Health will not enforce Administrative Order (AO) 346, which would have imposed a regulatory scheme for distributors of dietary supplements in Puerto Rico and ultimately limited public access to products. Instead, the Secretary agreed to go through proper channels of notice, including a hearing, followed by a comment and rule-making period later this year.

The Council for Responsible Nutrition’s (CRN) Vice President of Government Relations Mike Greene, welcomed the news, stating, “We’re very encouraged that the Secretary is open to dialoguing with businesses and industry about this situation. AO 346 would have a detrimental effect, both on consumers, who would be faced with higher prices on supplement products that are important for their health, and on businesses that contribute to the local economy.”

In February, when the issue first came to light, CRN began building coalitions, including one with the Puerto Rico Retailers Association, whose members and members’ customers, along with CRN’s manufacturers, would be negatively impacted.

“Our goal is to find common ground and mutual solutions,” said Mr. Greene. “We understand there are concerns about dangerous spiked products being illegally sold as dietary supplements, and we share that concern. It’s important, however, to separate the legitimate industry that manufactures and markets healthful products, such as multivitamins, calcium, fish oil and more, from those companies that are selling products that are illegal drugs, not legal dietary supplements. The fact is AO 346 would not solve the problem of illegal products, but it would instead harm companies, raise prices and inappropriately limit consumer access to popular and beneficial supplements.”

He continued to discuss CRN’s “boots-on-the-ground strategy.” “We focused on what was happening in Puerto Rico in the same way we address our state issues. Go directly to the source, get into the field, find out where the concerns lie, and determine how we can work together to protect both consumers and industry.” 

Mr. Greene further advised, “We are very pleased with this outcome and will continue to cooperate and communicate with those in Puerto Rico who have an ongoing stake in this issue. We will continue to explain our concerns about AO 346 and appreciate that there is now a public process in place. Our priority is to ensure that consumers continue to have access to safe, beneficial and affordable dietary supplements as part of people’s interest in promoting and maintaining good health. If we can help in solving the problem of drugs masquerading as supplements, we’re open to those conversations as well.”

The Natural Products Association (NPA) cited Puerto Rican newspaper El Vocero De Puerto Rico, which reported that provisions in the Puerto Rico Oversight, Management, and Economic Stability Act (PROMESA) ultimately forced the Secretary to delay the restrictions on the dietary supplement industry.  

In its outreach efforts, NPA focused on working with Congress to deal with AO 346. “We look forward to continuing our efforts to fully repeal this onerous and potentially illegal order,” said Daniel Fabricant, PhD, NPA’s executive director and CEO.

In a Sep. 2 letter to Members of the Congressional Task Force on Economic Growth in Puerto Rico, NPA said: “… the net effect of this Order is in NO manner beneficial to the people of Puerto Rico, by any measures of public health or by economic measure. Should the order stand in effect the net result will be: a lack of consumer choice on a commodity that over ½ of all Americans use daily to stay healthy (possibly yielding increased health care costs to the island); a loss of retail jobs for a growth industry that provides an estimated $50 M USD in gross revenue to the island annually; and the setting of a dangerous precedent that consumer goods that are in interstate commerce and regulated by Federal Authorities (i.e. the U.S. Food and Drug Administration) could be subject to, by states and territories, what effectively amounts to nothing more than an additional tax by administrative order with no incremental public health effect, a cost-benefit analysis where the denominator is zero, a policy where there is zero benefit only cost is not a good policy.

“As this Order was set forth under economic duress, it only makes sense that as that economic stability has been restored per PROMESA that such Orders be stricken as a matter of good governance. We ask the task force in their report to recommend that this order be repealed as it will not contribute to the economic stability of Puerto Rico, nor will it contribute to the health and wellness of its citizens.”