Public health experts recommend that states impose tighter controls on dietary supplement sales and marketing, saying federal regulations are insufficient and FDA does not have sufficient resources to enforce even the existing regulations.

In an analysis published online Sept. 23 by the Journal of Public Health Management & Practice, researchers reviewed studies reporting on U.S. consumers’ purchases of supplements marketed for weight loss or muscle building, focusing on how state and local governments, retailers and manufacturers should restrict sales of the products to adolescents.

“The lax federal regulatory scheme for dietary supplements leaves extreme gaps in federal oversight that should be filled by state governments. States should use core public health policy strategies to protect consumers and especially young people from ineffective, mislabeled, and potentially dangerous products marketed for weight control and muscle building,” the researchers, led by Jennifer Pomeranz, an assistant professor in Temple University Department of Public Health’s Center for Obesity Research and Education, state in their report.

“In light of the increasing cases of injury caused by these products, it is not wise to wait for unexpected federal change. State governments have a responsibility to protect adolescents and should act imminently,” they add.

Pomeranz said imposing new regulations in states is a matter of lawmakers enacting legislation and regulatory agencies implementing rules.

“State legislatures have the power to pass legislation to enact the requirements suggested in the paper. If a state or local health agency has or is granted the authority to take on these measures, it could similarly pass regulations to carry out the suggestions in the paper,” she said in an email.

For data on injuries linked to supplements, the researchers refer to studies they reviewed without reporting the data. They also cited other studies for details on U.S. consumers’ expectations for the existing regulation of nutritional supplement manufacturing and marketing by FDA and other agencies, saying “states should be more vocal about the fact that dietary supplements are not regulated in the manner expected by the American population.”

Members of Congress, in their arguments to support legislative proposals to require pre-market approvals for supplements and in their criticism of FDA enforcement in the sector, also have noted potential danger to young consumers from weight loss and bodybuilding supplements potentially tainted with drug ingredients Also see "Durbin Bill Would Narrow Definition Of Dietary Supplement" - Pink Sheet, 4 July, 2011..

Pomeranz encourages members of Congress to act on their frustrations with the supplement industry.

“Congress should grant the FDA increased authority and resources to address dietary supplements regardless of whether states act. Often when state and local governments act to protect public health, regulated businesses lobby Congress for national regulations, arguing … it is difficult to comply with different regulatory frameworks. However, states have a right to protect their citizens in a manner they see fit. If Congress acts, it should pass floor requirements and allow states to go further to protect their citizens,” he said.

Lawmakers in some states have proposed restricting sales of sports supplements to consumers 18 years and older, sparking concern from industry stakeholders that without additional enforcement activity by FDA, states will begin adopting their own, tighter regulations Also see "N.Y. Supplement Marketing Restriction Bill Raises Specter Of Copycats" - Pink Sheet, 27 May, 2013..

States Have ‘Police Power,’ AGs Have ‘Bully Pulpit’

Pomeranz and her colleagues explain that authority to enact laws to protect the health, safety, and general welfare of the public is a fundamental element of state government, “police power.” This authority allows states to regulate products and the retail environment through direct controls or conditional licensing, such as ordering retailers not to sell certain supplement products to consumers younger than 18 years.

They acknowledge the Federal Trade Commission’s enforcement against weight loss products making false claims, but say that state attorneys general can “use their bully pulpit” for greater results in stopping misleading claims.

Existing consumer protection statutes in each state and the District of Columbia mirror FTC’s prohibition on unfair or deceptive acts or practices and typically are enforced by state AGs.

The researchers argue that although supplement manufacturing and marketing is regulated by FDA under the Dietary Supplement Health and Education Act, state AGs are in a stronger position than FDA to require supplement firms to back up their ad claims with evidence.

They maintain that because DSHEA frees supplements from pre-market approval, FDA is not authorized to demand firms provide substantiation for products’ claims or safety before the agency first conducts its own studies.

“Unlike the FDA, AGs can require companies to turn over substantiation documents so that if they question a claim on a supplement’s packaging, they do not have to conduct their own research before taking action,” according to the report.

However, the enforcement activity the researchers describe for state officials is similar to FDA’s existing authority to warn firms about violative claims, non-compliant ingredients, misbranding or good manufacturing practices problems, and to order product recalls when the agency determines a supplement is unsafe.

Bodybuilding supplement marketers’ withdrawal of dimethylamylamine-containing products in 2012 and 2013 after FDA, responding to concerns about the substance’s safety, said DMAA is not a dietary ingredient, illustrates the agency’s authority to police the market Also see "FDA Ushers Out Known DMAA, Closes Dietary Ingredient Door" - Pink Sheet, 22 April, 2013..

Trade Groups Question Findings

The Council for Responsible Nutrition says the researchers’ understanding of FDA’s regulatory authority established by DSHEA is inaccurate and questions how different regulations imposed in different states would help consumers.

“It’s concerning that these recommendations mischaracterize the extent of the problem as well as the federal laws already in place. Contrary to the authors’ assertions, DSHEA did not strip FDA of premarket approval authority, but instead added enforcement provisions, which along with subsequent legislation, gave FDA stronger enforcement authority,” said Judy Blatman, CRN’s senior VP of communications.

CRN acknowledges, though, that FDA enforcement against firms violating supplement manufacturing and marketing regulations sometimes has not been robust. But state regulations will not buttress the agency’s work, Blatman said in an email.

“FDA has all the tools and authority it needs to protect consumers; now we need to see the agency use more of its regulatory enforcement muscle to go above and beyond warning letters when warranted. Creating a patchwork of state-by-state legislation is overly burdensome for companies following the law, and creates disruption in the marketplace.”

In addition to the researchers’ familiarity with supplement industry regulation under DSHEA, Natural Products Association President and Executive Director Daniel Fabricant questions their description of states’ authority to age-restrict supplement sales.

“It’s a tough trick to pull off. I’m not sure how they’d actually get to that point,” he said.

Fabricant added that the report failed to acknowledge FDA warns firms about potentially unsafe supplements when necessary, such as DMAA-containing products, and manufacturers and marketers typically pull targeted products off the market at the agency’s request.

He said close to $2 billion in products were recalled from stores during his tenure as FDA’s supplement division head, from February 2011 through April 2014, after the agency found problems with the products. “The paper doesn’t really state what the empirical evidence is, which is that the federal regulator is active,” Fabricant said.

Bans, Taxes And Age Restrictions

In addition to state AGs enforcing against false claims, the researchers recommend that states exercise their authority to ban sales of unsafe products and that they refuse to wait for FDA to act. Several states banned sales of supplements containing ephedrine alkaloids before FDA prohibited use of the ingredient in 2004, they note.

“When evidence increases about the dangers of new products, states can enact prohibitions on their sale prior to FDA action,” the report says.

While FDA regulations preempt states from requiring information on supplement product labels not required under DSHEA, states are allowed to require retailers to post warnings about the safety of ingredients.

The report suggests states consider requiring retail establishments to place point-of-sale signs with statements such as supplements are not required to be tested or evaluated for safety by the FDA, or safety alerts on products linked to injury with overuse of an ingredient.

“Future research should be conducted to evaluate whether the warnings effectively convey product risks and do not encourage use by adolescents looking to engage in risky behavior,” Pomeranz and her colleagues recommend.

Increasing the amount of tax charged for weight loss and bodybuilding supplement sales likely would discourage young consumers as it has with their purchases of alcohol and tobacco, the study says. Revenues from the taxes, the researchers add, could help fund states’ other regulatory activities related to supplements.

“Additional research into the economic implications of such a tax is warranted to determine whether a small tax could generate enough revenue to implement other controls or whether a larger tax would discourage consumption or just ultimately be regressive for low-income persistent users,” they say.

The researchers also say states have authority to limit sales of certain products to consumers 18 years and older, as several states did for ephedrine-containing weight loss supplements prior to FDA’s ban.

Additionally, the report suggests that retailers voluntarily age-restrict sales of weight loss and bodybuilding supplements, or stop selling the products.

Pomeranz notes CVS Health’s move on tobacco products as an example for retailers’ sales of some supplements.

“We were very impressed with [CVS’] decision to stop selling tobacco products. Retailers can consider similar measures or age limits to protect youth from potential harm caused by these products,” she said.

The researchers also recommend manufacturers volunteer to have U.S. Pharmacopeia inspect their facilities for GMP compliance and test their products.

NPA and multiple industry consulting groups provide GMP audits for supplement manufacturers, and firms commonly promote on product labeling that their ingredients are tested by third-party organizations.

State Enforcement Needed On Weight Loss, Bodybuilding Supplements – Study

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