FDA raises constitutional law questions in a recent caution to consumers about potential hazards of using dietary supplements while taking OTC or Rx medicines, the Natural Products Association tells the agency.

Questioning FDA’s reasoning for multiple elements of the Consumer Update, “Mixing Medications and Dietary Supplements Can Endanger Your Health,” NPA primarily objected to the agency suggesting that labeling for some supplement products should include warnings about their use with OTC or prescription drugs.

The suggestion, NPA argues in an Oct. 31 letter to FDA’s Office of External Affairs/Office of Media Affairs Leadership, points to the agency compelling supplement marketers to use labeling language without evidence supporting the requirement.

“It is unclear as to why the FDA positioned its communication that dietary supplements pose more risk or harm than other foods when used with pharmaceuticals. If the FDA seeks to make such a statement, it must have compelling evidence.” – NPA letter to FDA

“Your consumer update suggests that some dietary supplements need a warning statement, when compelling such a warning label on dietary supplement products would require convincing evidence rather than mere speculation or furthering a stated interest by informing consumers,” according to the letter written by Lauren Cohen, NPA’s VP for public relations and communications.

NPA requests that FDA “clarify the inaccuracies in this piece so that consumers can be better educated on the topic.”

The trade group notes that in Central Hudson Gas & Electric Corp. v. New York Public Service Commission, the Second Circuit Court of Appeals’ decision, upheld in 1980 by the Supreme Court, also would apply to FDA’s suggestion for a drug interaction warning statement on supplement labels.

The circuit court held that the Public Service Commission did not claim that health or safety concerns prompted passage of a ban on promotional advertising by an electrical utility, but the commission’s interest relied on informing consumers.

The court said the government must show that a regulation directly advances a substantial interest and is no more restrictive of speech than is necessary. The commission’s interest “in the public right to know” was “insufficient to justify compromising protected constitutional rights” under the First Amendment, the court said.

The court said the commission’s ban also violated the Fourteenth Amendment guarantee of equal protection under the law and of due process.

Cohen points out FDA has never pursued the requirement of a label warning regarding supplements’ interaction with pharmaceuticals.

While FDA has a burden to show the dangers it warns of in the Consumer Update are real and that the supplement label warnings it suggested would alleviate the problem, the agency has stated no “material fact with evidence or empirical data” about the problem it describes.

“The Supreme Court’s use of the Central Hudson test should be the standard by which food law regulations are analyzed, whether bans, required disclosures or warnings,” Cohen says.

“NPA believes it is misleading for the agency to draw the conclusion in a statement to consumers that dietary supplements are putting them at risk more than other categories of food” … and “it is unclear as to why the FDA positioned its communication that dietary supplements pose more risk or harm than other foods when used with pharmaceuticals. If the FDA seeks to make such a statement, it must have compelling evidence. The comments in the consumer advisory were irresponsible in the absence of material fact to compel a label warning on dietary supplements,” according to the letter.

A food and drug attorney, who asked to comment without attribution, noted that NPA’s letter indicates to its members and other stakeholders that the trade group is contacting FDA about a potentially troubling statement by the agency.

However, FDA is not proposing a rule but is using its “bully pulpit” to identify a concern to consumers.

“What’s the First Amendment problem? In fact, in the commercial speech context, the courts often say that an alternative to an agency regulation that might offend the First Amendment is for the government to engage in its own speech. This is what FDA is doing via” the Consumer Update, the attorney said.

FDA Supplement Regulations ‘Robust’

Moreover, NPA asserts, warning statements already are required on medications about potential danger from using a particular drug in combination with other drugs or with certain dietary ingredients. However, FDA’s Consumer Update implies that supplements are required to bear the label warnings.

“The messaging here creates confusion, as now consumers may falsely believe that the supplements they are taking each day should contain warning statements or that the products are misbranded because they fail to declare a particular warning statement.”

Additionally, FDA’s description in the update about the agency’s regulatory oversight of the supplement industry could impress consumers that their vitamins and other supplements are made in an unregulated sector of the health care products space, Cohen says.

FDA tells consumers the agency “does not review supplements for effectiveness (as it does for prescription and OTC medications) before they enter the market,” and explains that new dietary ingredient notifications required from manufacturers “are on that ingredient’s safety—but not its effectiveness.”

The Consumer Update, NPA argues, failed to note the “supplement industry has many robust agency regulations in place” and “supplements are regulated as a food product under the Dietary Supplement Health and Education Act, and consistently meet the government and industry standards that have been set.”

Cohen adds that supplements are the only category of food products required to submit serious adverse event reports to FDA and to include on labels contact information for consumers to report serious adverse events. “No other categories of food are required to do this. The agency must ensure it is even-handed and science-based toward public health concerns to keep consumers safe.”

Under DSHEA, FDA also requires labeling for a supplement to identify the product as a supplement; list its ingredients and their daily nutrient value; provide serving-size and usage information; and include a statement that FDA has not evaluated any claim for the product and that the product is not intended to diagnose, treat, cure or prevent any diseases.

FDA officials said the agency would comment on questions about NPA’s letter after responding to the trade group.

In an email, Cohen said NPA has yet to hear from FDA about the letter. “We don’t know if the FDA will re-publish the update with different language, but we look forward to following up with them in that regard,” she said.

FDA Touches Constitutional Nerve In Warning On Mixing Supplements, Drugs – NPA

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