The dietary supplement industry was able to block new legislation in the Puerto Rican Senate that many argued was an attempt to legitimize an earlier administrative order from island health officials that imposed new registration, inspection and fee requirements on manufacturers, distributors and retailers selling natural products, including dietary supplements, in Puerto Rico.
José L. Dalmau Santiago, vice president of the Puerto Rican Senate (Senado), introduced legislation P. del S.1599, co-authored by P.R. Senator Antonio J. Fas Alzamora, seeking to amend the Law of Pharmacy in Puerto Rico (247-2014) to create a definition of natural products and nutritional or dietary supplements. The proposed legislation noted the Law of Pharmacy established several authorities of the Puerto Rico Health Department, which include natural products such as nutritional and dietary supplements. Further, the legislation detailed how health officials have identified a significant increase in availability and accessibility, as well as marketing, of such natural products at various points of retail on the island.
In his legislation, Dalmau Santiago included a statement on the potential dangers of supplements: “Nutritional or dietary supplements may contain active ingredients that have biological effects in the body and could be harmful if combined with other supplements, if used as medicines, and replaced by medications or taken in excess." (Translated from Spanish.)
The legislation stated FDA determines the “definition" of natural product based on its intended use, which can be established by product labeling, marketing and distribution. Instead, the law of pharmacy for Puerto Rico would be amended to establish a definition of natural products that would exclude formulas that contain active ingredients that are synthetic compounds or constituents isolated from herbal materials.
While it emphasized any natural product or dietary supplement must adhere to FDA regulations, it also stated such products need to adhere to any other provision of law from the Puerto Rico health Department.
U.S. natural products industry leaders argued the proposed legislation sought to legitimize Administrative Order #346, which was implemented by the P.R. Health Department earlier this year and amounted to an unfair tax on the supplement industry. The industry further claimed the order imposed redundant requirements, as dietary supplements are already regulated by U.S. federal law.
The Council for Responsible Nutrition (CRN) said it engaged the Puerto Rico Department of Health as well as key members of the P.R. Senate and House, in an attempt to stop P.delS.1599 in its tracks. CRN also reported meeting with a coalition of retailers on the island who would be directly impacted by Order #346.
The Natural Products Association (NPA), which had previously countered the administrative order by helping to get an amendment attached to the Puerto Rico Oversight, Management and Economic Stability Act (PROMESA, HR 5278), used its existing grassroots efforts on the order to generate 1,400 emails overnight to P.R. legislators to block P. del S.1599.
P. del S.1599 was introduced in the P.R. Senate on June 23 but failed to move in the P.R. House (La Cámara) two days later.
“The success in defeating this bill is due to the collective effort of the industry and the fact that Puerto Ricans want reasonable access to these products," said Mike Greene, vice president of government relations, CRN. “CRN is pleased to have garnered such strength in numbers with the help of its member companies, industry allies and consumers. However, we’re keeping close watch on what’s happening in Puerto Rico and staying vigilant to protect the industry and the people who value dietary supplements."
Dan Fabricant, Ph.D., CEO and executive director of NPA, said the key takeaway is that this administrative order #346 is not going away on its own. “Folks in the industry might have thought the island was going to be helpful against this order, but that is obviously not the case," he said, referring to P. del S.1599. He further noted the tactic of using an amendment to PROMESA in the U.S. Congress only addresses an administrative order, and a law similar to what P. del S.1599 attempted to install might require a different approach.
For more on Administrative Order #346, check out the recent in-depth INSIDER article Puerto Rico Dietary Supplement Order a ‘Money Grab’ and the Healthy Insider Podcast: The Fight Against New Natural Products Regs in Puerto Rico.