By Mike Montemarano, Associate Editor, Nutraceuticals World04.22.20
The role that regulatory agencies play in enforcing the substantiation of health claims attached to nutritional supplements has been under heightened scrutiny since the onset of the COVID-19 pandemic. It’s an even hotter debate in the state of Oregon, where a proposed rule by the state Attorney General’s Office would allow actors within the state courts, and possibly even private actors, to file suits against companies based on allegations that any advertised health claims aren’t “competent and reliable” enough.
The Oregon AG’s Office has agreed to postpone a decision regarding a proposed new rule, which would, summarily, make it an unfair and deceptive practice to represent that a product has a health benefit without “competent and reliable scientific evidence,” which the state’s Department of Justice describes as “on par” with the regulations already in place by the Federal Trade Commission (FTC). The Department of Justice (DOJ) began accepting public comment on the potential rule roughly five years ago.
The proposed rule has drawn scrutiny and criticism from trade associations representing the dietary supplement industry, including the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA).
“If the COVID-19 pandemic has taught us anything, it is that nutritional supplements, such as vitamin C, that make health claims are an important element to supporting the healthy lifestyles of the American people,” NPA President and CEO Daniel Fabricant, PhD, said in a statement. “Oregon’s order depletes taxpayer resources and is unnecessary. If Oregon regulators believe there is an abundance of products making fraudulent health claims, then we are happy to work with them to protect consumers. Federal regulators already prevent companies from making false or misleading claims about a product.”
Originally, the timetable for the DOJ to reach a decision on the proposed rule was slated to end on Apr. 10, however, the AG’s office will be postponing the decision for at least six months, according to CRN.
“CRN is pleased with the decision of the Oregon AG to postpone the rulemaking, as it would increase the burden on manufacturers and retailers in Oregon and decrease consumers’ access to information about the potential health benefits of products,” Megan Olsen, CRN’s vice president and associate general counsel, said. “We share the DOJ’s concern for bad actors making false and fraudulent claims that take advantage of consumers, especially during a public health crisis, but this regulation is not the answer.”
If enacted, the proposed rule would designate state and local government agencies as responsible for sending complaints from the public regarding unsubstantiated health goods to the DOJ, which would in turn consider enforcement action based on marketing guidelines it publishes pending the government’s passage of the proposed rule change.
The DOJ states that the impact of this rule is mitigated by the fact that the FTC enforces the same standards as this proposed rule nationally, and that in making this rule enforceable at the state level, no unique burden is placed on those who market consumer products with health benefit claims.
In a joint letter to the Oregon AG’s office, filed in November of last year by AHPA and CRN, the two trade associations expressed concerns that the proposed rule would create a private right of action against companies in the state of Oregon.
CRN and AHPA are concerned that by the DOJ making the FTC’s existing standards enforceable at the level of state government, private plaintiffs would be able to “initiate a lawsuit simply by alleging—without engaging in scientific evaluation or public interest analysis—that a company making a health benefit claim does not have competent and reliable scientific evidence to support the claim.
“A private right of action would stand as an aberration from the practices of numerous jurisdictions supported by their respective courts—that only regulators can bring a lawsuit based on an alleged lack of substantiation,” CRN and AHPA said. “Private plaintiffs, on the other hand, must prove that the claim being made is actually false. This distinction between public and private actions serves critical functions. Not only does it protect businesses from the burden of defending baseless litigation, but more importantly, it has the primary purpose of protecting public health by ensuring that substantiation is reviewed by government actors who are uniquely equipped with scientific expertise and a public interest mindset.”
CRN and AHPA believe that regulators should be the sole parties involved in weighing the scientific substantiation behind any health claim.
“If private actors are independently allowed to demand substantiation and seize on any inconsistency or weakness that might be found in a complex body of research to allege that an advertiser does not have competent and reliable scientific evidence to support a claim, both advertisers—and consumers who rely on their products—stand to be harmed.”
Additionally, the associations believe that a patchwork of conflicting decisions on any single dietary ingredient dilutes the significance and authority of government actors, and can discourage the dissemination of information in the nutrition space, which could have negative consequences for public health. The duplicative nature of the proposed rule, NPA argued, offers no assurance that the state will interpret scientific evidence with the same experience and expertise that the FDA and FTC possess.
The Oregon AG’s Office has agreed to postpone a decision regarding a proposed new rule, which would, summarily, make it an unfair and deceptive practice to represent that a product has a health benefit without “competent and reliable scientific evidence,” which the state’s Department of Justice describes as “on par” with the regulations already in place by the Federal Trade Commission (FTC). The Department of Justice (DOJ) began accepting public comment on the potential rule roughly five years ago.
The proposed rule has drawn scrutiny and criticism from trade associations representing the dietary supplement industry, including the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA).
“If the COVID-19 pandemic has taught us anything, it is that nutritional supplements, such as vitamin C, that make health claims are an important element to supporting the healthy lifestyles of the American people,” NPA President and CEO Daniel Fabricant, PhD, said in a statement. “Oregon’s order depletes taxpayer resources and is unnecessary. If Oregon regulators believe there is an abundance of products making fraudulent health claims, then we are happy to work with them to protect consumers. Federal regulators already prevent companies from making false or misleading claims about a product.”
Originally, the timetable for the DOJ to reach a decision on the proposed rule was slated to end on Apr. 10, however, the AG’s office will be postponing the decision for at least six months, according to CRN.
“CRN is pleased with the decision of the Oregon AG to postpone the rulemaking, as it would increase the burden on manufacturers and retailers in Oregon and decrease consumers’ access to information about the potential health benefits of products,” Megan Olsen, CRN’s vice president and associate general counsel, said. “We share the DOJ’s concern for bad actors making false and fraudulent claims that take advantage of consumers, especially during a public health crisis, but this regulation is not the answer.”
If enacted, the proposed rule would designate state and local government agencies as responsible for sending complaints from the public regarding unsubstantiated health goods to the DOJ, which would in turn consider enforcement action based on marketing guidelines it publishes pending the government’s passage of the proposed rule change.
The DOJ states that the impact of this rule is mitigated by the fact that the FTC enforces the same standards as this proposed rule nationally, and that in making this rule enforceable at the state level, no unique burden is placed on those who market consumer products with health benefit claims.
In a joint letter to the Oregon AG’s office, filed in November of last year by AHPA and CRN, the two trade associations expressed concerns that the proposed rule would create a private right of action against companies in the state of Oregon.
CRN and AHPA are concerned that by the DOJ making the FTC’s existing standards enforceable at the level of state government, private plaintiffs would be able to “initiate a lawsuit simply by alleging—without engaging in scientific evaluation or public interest analysis—that a company making a health benefit claim does not have competent and reliable scientific evidence to support the claim.
“A private right of action would stand as an aberration from the practices of numerous jurisdictions supported by their respective courts—that only regulators can bring a lawsuit based on an alleged lack of substantiation,” CRN and AHPA said. “Private plaintiffs, on the other hand, must prove that the claim being made is actually false. This distinction between public and private actions serves critical functions. Not only does it protect businesses from the burden of defending baseless litigation, but more importantly, it has the primary purpose of protecting public health by ensuring that substantiation is reviewed by government actors who are uniquely equipped with scientific expertise and a public interest mindset.”
CRN and AHPA believe that regulators should be the sole parties involved in weighing the scientific substantiation behind any health claim.
“If private actors are independently allowed to demand substantiation and seize on any inconsistency or weakness that might be found in a complex body of research to allege that an advertiser does not have competent and reliable scientific evidence to support a claim, both advertisers—and consumers who rely on their products—stand to be harmed.”
Additionally, the associations believe that a patchwork of conflicting decisions on any single dietary ingredient dilutes the significance and authority of government actors, and can discourage the dissemination of information in the nutrition space, which could have negative consequences for public health. The duplicative nature of the proposed rule, NPA argued, offers no assurance that the state will interpret scientific evidence with the same experience and expertise that the FDA and FTC possess.
