A senator in the Legislative Assembly of Puerto Rico has introduced a bill that has renewed criticism from Washington-based dietary supplement trade associations. The Council for Responsible Nutrition (CRN) and Natural Products Association (NPA) challenged similar efforts on the island last year.
P.R. Senate Bill (SB) 219 would amend the Puerto Rico Pharmacy Act, requiring natural products and dietary supplements to register with the commonwealth’s health department, said Mike Greene, vice president of government relations with CRN.
The bill resembles legislation introduced last year in Puerto Rico, as well as an administrative order (#346) issued by the health department in 2016 that was the subject of a moratorium and drew the interest of a U.S. congressional task force.
“A lot of us thought that we were going to be working in Puerto Rico to share information about the benefits and quality and safety of supplements, and not necessarily have to deal with a bill like this again," Greene said in a phone interview.
The legislation, he said, “misses the nuance that dietary supplements are regulated as a category of food in the United States, not like drugs."
A similar bill (SB 1599) was introduced and passed in the commonwealth’s Senate last summer, but Greene said the legislation was halted in the P.R. House of Representatives.
The 2017 legislation, if passed into law, could help raise funds for the Caribbean nation, a U.S. territory that has endured severe economic woes. About 46 percent of residents on the island live below the federal poverty level—well above the national average of 14.7 percent, according to 2015 surveys cited by a U.S. congressional task force.
Supplement trade organizations argued registration requirements in Puerto Rico would subject companies to registration fees, reflecting an unprecedented burden. No U.S. state—or the federal government—presently requires such a registration system for dietary supplements.
NPA: Registration fees could devastate business
“People in the industry should be very afraid because this is effectively a state/territory saying, ‘Look, I’m going to tax these guys at will,’" said Daniel Fabricant, Ph.D., executive director and CEO of NPA, in a phone interview.
The bill, which does not explicitly mention registration fees, was introduced by Sen. José Luis Dalmau Santiago. He did not respond to a direct message sent to him in English via Twitter seeking comment.
In September, then-Puerto Rico Secretary of Health Ana Ríus Armendáriz, M.D., agreed to halt enforcement of a related administrative order. Administrative Order #346 would have imposed registration, inspection and fee requirements on manufacturers, distributors and certain retailers of dietary supplements on the island.
“Administrative order #346 entered into a moratorium process so that regulation could be drafted," said Yaritza Ortiz Sanchez, spokesperson for the Puerto Rico Health Department, in an email (translated) last year to Natural Products Insider. “When the regulation is completed, it will go through a process of public hearings so that stakeholders can participate."
Greene said products that register under the Puerto Rico Pharmacy Act, such as over-the-counter and prescription drugs, must pay fees like the fee structure outlined in Administrative Order #346. The order would have required the payment of US$25 “for the registration of any natural product for each and every concentration and for each and every size of the product to be registered," according to a translated version of the document Natural Products Insider obtained from CRN.
The registration fees aren’t feasible for the industry, Fabricant said.
“If you have 3,000 products in your store, you’ve got to pay $25 as a retailer for each of them. You’re not going to be able to stay in business," he said in a phone interview. “That’s part of your profit margin."
Scrutiny from Washington
In a report published in December, the U.S. Congressional Task Force on Economic Growth in Puerto Rico—mandated by PROMESA (Puerto Rico Oversight, Management, and Economic Stability Act)— said it received a letter in September from Armendáriz.
“The letter indicated that the Department of Health would issue an administrative order to place a 120-day ‘moratorium’ on Administrative Order 346, draft a ‘new regulation’ to replace the order that complied with Puerto Rico law, and hold ‘public hearings’ so that all affected parties could provide their ‘comments and recommendations,’" the task force stated.
In the report, the task force recommended the health department “follow through on the Secretary’s pledge to hold public hearings on the proposed regulation so that all stakeholders, whether they support or oppose administration action, can provide comments."
Sen. Orrin Hatch, the Republican from Utah and a staunch advocate of dietary supplements, is a member of the task force. J.P. Freire, a spokesman for Hatch, did not respond to a request for comment on Senate Bill 219. Neither did Sanchez of the Puerto Rico health department, which has a new secretary.
NPA planned to write to members of the congressional task force. “We’re going to let them know … that that is back, and they didn’t follow what the task force recommended," Fabricant said.
Fabricant, a former FDA official, said his trade group sought to engage in a dialogue with the Puerto Rico health department, but to no avail.
“We’ve reached out to people at the ministry of health on the island … ‘What are you actually trying to do?’ And for the life of us, no one’s been able to tell us," he explained.
Greene said SB 219 could set a dangerous precedent.
“If folks thought that it was beneficial in Puerto Rico, we might see if somewhere else in the states," he said. “We don’t believe there needs to be a registration on a state by state basis, and we’d like to stop it in Puerto Rico."
Greene said CRN was focused on a national registry for dietary supplement products, namely its Supplement OWL (Online Wellness Library), a self-regulatory initiative. He said the product registry would be accessible to various parties including regulators.
The extent to which Administrative Order #346, or SB 219, was motivated by the island’s desire to police dietary supplements is unclear.
“Nutritional or dietetic supplements may contain active ingredients that have biological effects on the body and may result in harm if combined with other supplements, if used as drugs, or substituted for drugs or taken in excess," a translated version of SB 219 states.
Puerto Rico is a U.S. territory, and FDA has explained its responsibilities extend to the island. Dietary supplement firms, however, are not required under the law to register their products with FDA, and the agency has said it has limited visibility in to the tens of thousands of supplement products on the U.S. market.
“If there are bad actors selling products on the island, we want FDA to fully enforce the law," Greene said. “FDA has the authority, but also is required, to address concerns on the island just as they address the concerns here in all the states."