CRN strengthens its engagement opposing Puerto Rico Administrative Order 346 (AO 346) by retaining an in-commonwealth consultant, fluent in Spanish, to assist. AO 346 requires registration of all dietary supplements sold in the commonwealth as well as registration for manufacturers, wholesalers and retailers of the products—all without any legislative authority for the Order. Recent efforts by U.S. Rep. Ryan Zinke (R-MT) to introduce an amendment to the Puerto Rico Debt Relief legislation that would have prevented enforcement of Administrative Order 346 (AO 346) failed to get Congressional action. While, Rep. Zinke’s amendment to the debt relief bill was deemed not germane to the legislation, the House Committee on Natural Resources did agree to include a study to determine the economic effect of the proposal (AO 346), with findings due back to Congress by Dec. 31. CRN believes that the most effective way to address industry concerns in Puerto Rico will be to address concerns locally rather than through Congress.

CRN alerted members in April to developments in the commonwealth of Puerto Rico, starting with AO 346, which requires all dietary supplement “natural products” (including synthetic) to register with the Division of Drugs and Pharmacies within the DOH. CRN is questioning whether the Department of Health has the legal authority to issue the order, as well as the order’s definition and scope of which products, exactly, would be included. In addition, legislation (SB 1599) was recently introduced amending the Puerto Rico Pharmacy Act (PRPA) defining natural products and dietary supplements, but it does not authorize registration. The PRPA requires registration of all drugs, OTCs, and medical devices sold or distributed in Puerto Rico. CRN believes there is no authorizing language requiring that dietary supplements register with the Department of Health. For more information, contact Ingrid Lebert (202-204-7699).

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