According Ingrid Lebert, senior director of government affairs for the Council for Responsible Nutrition, the investigation is called for by a resolution, which was introduced by Puerto Rico State Legislator Angel Bulerín Ramos and which unanimously passed the Puerto Rican House on February 7.
It directs the PR House Committee on Health to conduct an investigation into “the control mechanisms of the Department of Health and any other government entity involved, in order to safeguard the health and safety of Puerto Rican consumers of natural products and nutritional or dietary supplements, and for other related purposes.”
Lebert said that it has been a struggle to get legislators in the commonwealth to understand the full scope of laws and regulations that already govern the industry on the federal level.
“We have been on island for a while now working on various issues. Each and every time I go over everything that’s on the books already, and they seem to misunderstand. So I’m supportive of the concept of this investigation if it is a way for them to recognize and understand the full complement of regulations that are already in place,” Lebert told NutraIngredients-USA.
Legislators concerned about supplement regulation for several years
CRN and the Natural Products Association both say they have been seeking to restrain efforts in Puerto Rico to regulate the dietary supplement industry on the local level for several years now.
Those efforts resulted in a victory of sorts in late December, when Puerto Rico has passed legislation that allows supplement companies doing business there to sidestep previous legislation that the industry had objected to as burdensome and unnecessary.
Early in 2017, a move was announced by the commonwealth government to specifically regulate dietary supplements. Companies wanting to sell products there would have to apply for a certification from the commonwealth government.
Registration requirement dates back to 2016
CRN was among the trade organizations that objected to the requirement in 2016 when it was first put forward in the form of an administrative order under then Secretary of Health Ana Ríus Armendáriz.
CRN noted it added an unnecessary level of bureaucracy and did nothing to further protect consumers in the state. Rather, it was seen primarily as an attempt to collect a new slate of fees.
The law signed in late December states that dietary supplement companies that are already required to register under FSMA and Bioterrorism Act provisions will be exempt from complying with the commonwealth’s own registration requirements.
While that requirement remains on the books as Regulation 9031, the law signed in late December means that for all intents and purposes, for the dietary supplement industry it has become a dead letter.