NPA and CRN reject ACP call for US supplement regulatory overhaul and premarket approval
Key takeaways
- The NPA and CRN reject the ACP’s call to modernize the DSHEA framework as they argue that US supplements are already sufficiently regulated.
- The organizations oppose premarket approval with the FDA and regulating supplements as pharmaceuticals, which would limit product access and undermine Congress.
- CRN suggests targeted modernization of the legislation, such as adverse-event reporting and stronger FDA funding.
The Natural Products Association (NPA) and Council for Responsible Nutrition (CRN) counter recent recommendations to modernize the US supplement legislation framework, such as premarket authorization or regulating these products as pharmaceuticals.
In a position paper, the American College of Physicians (ACP) recently recommended policy adoptions to modernize the regulation of dietary supplements in the US to protect consumer health. The organization urged policymakers to strengthen the manufacturing and marketing of dietary supplements.
ACP argues that the US Dietary Supplement Health and Education Act of 1994 (DSHEA) is outdated. It called on Congress to modernize this framework to require supplements to undergo an evidence-based review, registration, and premarket approval with the US FDA, alongside meeting quality standards as established by the US Pharmacopeia.
The NPA says these changes would impede access to safe, natural products, kill dietary ingredient innovation, increase consumer costs, and regulate dietary supplements as pharmaceuticals.
“The dietary supplement industry is more than adequately regulated, and it has a long-established track record of safety,” says Daniel Fabricant, Ph.D., president and CEO of NPA.
CRN adds that the primary problems identified throughout the paper — including adulterated products, unlawful disease claims, fraudulent marketing, and products containing illegal pharmaceutical ingredients — are already prohibited under existing law. “These examples do not demonstrate that DSHEA has failed; they demonstrate the need for stronger enforcement against companies that violate it.”
FDA authority
CRN says it supports several of the objectives ACP outlined in its paper, such as removing adulterated products from the market, strengthening FDA oversight, improving physician-patient communication about supplements, expanding nutrition research, and ensuring consumers have access to accurate, science-based information.
CRN calls for targeted modernization of DSHEA, such as reporting serious adverse events, and urges Congress to increase FDA funding.However, it counters: “The solution is not to regulate vitamins, minerals, probiotics, and other dietary supplements like prescription drugs. Congress intentionally established a distinct regulatory framework recognizing that supplements are intended to support health, not diagnose, treat, cure, or prevent disease.”
For example, CRN explains that Congress has limited the types of ingredients that can be used in supplements and restricted the types of claims that can be made. Premarket approval through the FDA would create a regulatory burden, reduce product access, stifle innovation, and divert FDA resources away from actors that pose the greatest health risk, argues the organization.
NPA’s Fabricant, who oversaw the FDA’s Division of Dietary Supplement Programs during President Barack Obama’s administration, adds: “Congress has delegated authority to the FDA to routinely inspect manufacturing facilities, assess the safety of new dietary ingredients, and review serious adverse event reports, which could trigger FDA actions to protect the public, including mandatory recalls, seizures of products, injunctions and criminal prosecutions.”
He believes ACP’s proposals would “eviscerate the regulatory distinctions” between pharmaceuticals and dietary supplements, undermining congressional intent in DSHEA and depriving American consumers of unfettered access to safe, beneficial nutritional products.
Value of supplements
Meanwhile, NPA notes that the FDA and current US administration have explicitly recognized the value of dietary supplement products as part of a multi-pronged strategy to promote health and wellness.
Additionally, it highlights that the Secretary of the US Department of Health and Human Services (HHS) has emphasized the need for US medical establishments to educate their students on the crucial role of prevention and nutrition.
Fabricant argues the ACP proposals would erase the regulatory line between supplements and pharmaceuticals.In March this year, HHS Secretary Robert F. Kennedy Jr. formed an agreement with 53 medical schools across the country to include 40 hours of nutrition education instead of two.
“It’s ironic that the ACP wants to treat dietary supplements as FDA-approved drugs during an administration that has recognized the urgent need for formal medical education about the value of nutrition and prevention,” says Fabricant.
“Consumers who use supplements and engage in self-care achieve better health outcomes. Unfortunately, ACP is tone-deaf to the growing role of dietary supplements as part of a healthy lifestyle focused on nutrition and prevention of disease. NPA will continue to fiercely oppose any proposals to dismantle the strong regulatory framework under DSHEA.”
Targeted modernization
CRN notes that it has long advocated for a targeted modernization of the existing framework. For example, it has supported legislation requiring supplement companies to report serious adverse effects to the FDA and has called for a product registry as a modernization of FDA oversight.
It also urges Congress to increase funding to the FDA to ensure regulatory compliance and take “aggressive enforcement actions” against companies that violate the law.
“These practical reforms would provide the FDA with greater visibility into the marketplace and strengthen its ability to identify and remove illegal products without disrupting responsible manufacturers or limiting consumer choice.”
The organization also agrees that health care providers should routinely discuss dietary supplement use with patients, but cautions that misinformation and fear-mongering toward supplements with a “legacy” of safe use will shut down productive conversations.
“Ultimately, the choice is not between today’s regulatory framework and pharmaceutical regulation,” concludes CRN. “It is between targeted modernization that strengthens FDA’s ability to enforce the law and a sweeping overhaul that would burden responsible companies while doing little to deter those already operating outside the law.”
