WASHINGTON – Today, the United States Senate ignored the dietary supplement industry by continuing to move forward with crippling provisions left in the Food and Drug Administration Safety and Landmark Advancement Act (FDASLA). The NPA requested from the Senate HELP committee in a series of letters that the committee strike the entire dietary supplement section of the FDASLA or include provisions that prohibit the FDA from excluding or removing products from the listing unless and until the product is subject to final agency action.
“The reauthorization of the FDA user fee program is not the appropriate vehicle to include controversial dietary supplement legislation, especially since it has not undergone the appropriate committee review and debate,” said Daniel Fabricant, Ph.D. president and CEO of the Natural Products Association (NPA).
“A public database as proposed in the FDASLA is completely inconsistent with the facility registration provisions of the Bioterrorism Act. Twenty years ago, Congress decided there was a compelling reason to protect specific information about dietary supplement production from falling into the hands of people with malicious intent. The current version of the FDASLA insufficiently shields critical pieces of information.”
“Over 100,000 constituents have contacted to register their strong opposition to the dietary supplement provisions in the FDASLA. Our industry has never been required to pay user fees, nor do we have pre-emption from state tort claims that exist for other FDA-regulated products. Prohibiting the FDA from excluding or removing products from the listing unless there is final agency action is the only way the industry can preserve any due-process rights against the agency should a dispute arrive, like the current disputes over CBD and NAC. Otherwise, the agency could still use MPL as a basis to deny or de-list products containing disputed ingredients, even if the “prohibited act” language discussed earlier were removed and even with the addition of the language about premarket approval.”
NPA encourages all health and wellness advocates to continue writing their members of Congress through the NPA Action Center here. Grassroots involvement has been critical and is desperately needed to defeat this proposal.