NEW REGULATION FOR NATURAL PRODUCTS AND NUTRITIONAL OR DIETARY SUPPLEMENTS





On June 30, 2018 came into effect Regulation No. 9031 of the Secretary of Health directed to the Operation of Establishments Dedicated to the Manufacture, Distribution and Sale of Natural Products and Nutritional Supplements in Puerto Rico. This Regulation is promulgated by the "Organic Law of the Department of Health, of the" Food, Drug and Cosmetic Act of Puerto Rico ", and of the 21 Code Federal Regulation applied by the Food and Drug Administration - FDA.


The promulgation of this new regulation is the result of evaluation of comments received in October and November 2016 in public view and written presentations on proposal based on provisions of the Pharmacy Act of Puerto Rico and the Law To regulate the Exercise of Naturopathic Medicine in Puerto Rico. The College of Pharmacists presented and evidenced its opposition to the approval of said proposal. We are pleased to recognize that recommendations in the CFPR's presentation were welcomed, among them, that the regulation of natural products and nutritional supplements responded to provisions of the current Food, Drug and Cosmetic Act of Puerto Rico. Below, we summarize some of the main provisions of REGULATION 9031.


The Secretary of Health will have the power to regulate the operations of establishments dedicated to the manufacture, distribution and sale of natural products and nutritional supplements that are marketed in the form of tablets, capsules, pearls, gel capsules, powders or liquids in the State. Free Associate of Puerto Rico, as well as the fulfillment of all that legislation and state, federal regulation and new standards, applicable in Puerto Rico.



Specifically, in the Regulation it is stated that: "The purpose of this Regulation is to protect public health by monitoring the integrity of natural products and nutritional supplements that are marketed in the form of tablets, capsules, pearls, gel capsules, powders or liquids that are available and accessible to citizens. In this way, the Department of Health fulfills its ministerial duty to protect public health by avoiding the indiscriminate use of products that are unfit for health. These products may contain active ingredients that have biological effects on the body or that could be harmful if used with other products, used as medicines, replaced by medications or taken in excess. These products are not medicines, so they are not intended to diagnose, treat, prevent or cure diseases. "


In the regulation when mentioning "natural products" refers to those products that are obtained when substances of herbs or plant material are subjected to treatments such as extraction, distillation, fractionation, purification, concentration or fermentation. This includes crushed or powdered herbal substances, dyes, extracts, essence oils and extracted juices. The natural products may contain organic and / or inorganic active ingredients that are not of vegetable origin (for example, of animal or mineral origin) or excipients, inactive substances. As "natural handicraft products" refers to a product that is produced mainly by hand, that its ingredients or components are specifically of natural origin, and that they will not contain any chemical ingredient except those necessary to complete the manufacturing process.


In the regulation when mentioning "natural products" refers to those products that are obtained when substances of herbs or plant material are subjected to treatments such as extraction, distillation, fractionation, purification, concentration or fermentation. This includes crushed or powdered herbal substances, dyes, extracts, essence oils and extracted juices. The natural products may contain organic and / or inorganic active ingredients that are not of vegetable origin (for example, of animal or mineral origin) or excipients, inactive substances. As "natural handicraft products" refers to a product that is produced mainly by hand, that its ingredients or components are specifically of natural origin, and that they will not contain any chemical ingredient except those necessary to complete the manufacturing process.


Under "nutritional supplement or dietary supplement" refers to products, excluding tobacco, intended to supplement the diet that comprise or contain one or more of the following dietary ingredients: vitamin; mineral; grass or other botanical product; amino acid; Dietary substance for human consumption to supplement the diet by increasing the dietary intake, or a concentrate, metabolite, constituent, extract or a combination of any of the ingredients mentioned above. In addition, they are products intended for ingestion, their use is not represented as conventional food or as a single item of a food or diet and are labeled as dietary supplements.


Any person interested in the manufacture, distribution and sale of natural products and nutritional supplements, in Puerto Rico, must request and obtain the corresponding certification issued by the Secretary of Health, through the Auxiliary Secretariat for Regulation and Accreditation of Facilities. Health (SARAFS). Establishments authorized to manufacture, distribute and dispense medications under the Pharmacy Act of Puerto Rico are exempt from the requirement of this certification.