Background
On February 9th, 2016, the Puerto Rican Secretary of Health issued Administrative Order #346 (“Order”), imposed a regulatory scheme in Puerto Rico for all retailers and distributors of dietary supplements in Puerto Rico — all without approval from Puerto Rico’s legislature and without any prior notice and comment period. This Order imposed fees and represented a money grab. NPA fought to execute a stay as part of PROMESA, an economic bailout of this U.S. territory. There are threats from the State Senate and Assembly of Puerto Rico to impose similar registration fees and requirements again, only for retailers of dietary supplements (drug stores would be exempt). These proposals add no public health value as much as what has been proposed already mirrors much of what is already currently filed with U.S. FDA.
Issue
The efforts by Puerto Rico would duplicate much of what is already available to them through the FDA but imposes an additional significant administrative burden by requiring Quality control data, Certificates of Analysis, the process used to obtain the product, label samples, promotional materials, advertisements, laboratory certificates, etc in addition to fees and schemes for product registration, which are not required by US federal law, Puerto Rico is a US territory.
