NPA Engages PROMESA Task Force on Puerto Rico Supplement LawNPA Engages PROMESA Task Force on Puerto Rico Supplement Law
The Natural Products Association is meeting with members of the Congressional Task Force charged with evaluating Puerto Rico’s administrative order establishing new registration and inspection requirements for dietary supplements.
August 9, 2016
The Natural Products Association (NPA) will meet with members of the Congressional Task Force that will evaluate and issue recommendations to Congress for a new Puerto Rican law that would impose new registration, inspection and fee requirements on dietary supplements sold on the island. The task force was established by PROMESA (the Puerto Rico Oversight, Management and Economic Stability Act) and must submit a report to Congress on economic growth prospects in Puerto Rico, including the supplement law, by the end of the year.
Administrative order #346 was instituted by the Puerto Rico Department of Health in February 2016 and would require any manufacturer or distributor (including retailers) to register with the health department. Each natural product—the focus is on dietary supplements—must be registered. Each registration must include quality control data (certificates of analysis [CoAs]); label sample; promotional/advertising materials; warnings; info on the process used to obtain the product; and lab CoAs, including name, address and contact info for the manufacturer, and FDA registration number.
There are separate fees for products, facilities, manufacturers, wholesale distributors and retailers, although drug stores and pharmacies are exempt.
The dietary supplement industry has argued this administrative order is redundant, as manufacturers are already required to register with FDA, and the requirements would hurt Puerto Rico’s economic growth and its citizens.
The bipartisan task force includes members from both the U.S. House and Senate and is chaired by Sen. Orrin Hatch (R-Utah), who is the Senate Finance Committee Chair and is very experienced in dietary supplement issues.
NPA , which set up a grassroots response that helped convince Rep. Ryan Zinke (R-Montana) to put the administrative order onto the task force’s list of considerations, reported it will meet with all eight task force members in the coming weeks.
“NPA will work directly with the Task Force to inform its members of the damaging impact this order will have on consumers and economic growth in Puerto Rico," said Daniel Fabricant, Ph.D., CEO and executive director of NPA. “We are optimistic that the report will encourage the federal government to remove economic impediments that keep Puerto Ricans from enjoying the extensive health benefits of dietary supplements and other natural products."
The task force is accepting stakeholder input through Sept. 2, 2016.
“Information and insights, from both the public and private sectors in Puerto Rico, will be useful to the Task Force as it analyzes impediments to growth on the island stemming from Federal law and programs and arrives at recommendations to remove current barriers to growth," the task force said, in a joint statement.
Comments can be submitted to the task force’s mailbox at [email protected].
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