Mandatory Product Listing Inches Closer to Reality

Denis Storey
July 8, 2022

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After years of inaction, Congress appears poised to act on the dietary supplement industry’s greatest fear: a mandatory product registry.

On June 14, the U.S. Senate’s Health, Education, Labor, and Pensions (HELP) Committee signed off on the FDA Safety and Landmark Advancements (FDASLA) Act (Senate Bill 4348), which includes several changes to dietary supplement regulation. The legislation, introduced by U.S> Sen. Patty Murray, D-Washington, would amend Chapter IV of the Federal Food, Drug, and Cosmetic Act.

Most importantly, the proposed legislation would require companies to list their products with the U.S. Food and Drug Administration. The required information would include:

  • The name of the supplement.
  • The name and address of the manufacturer, packer, or distributor on the label, and the relevant contact information for the owner or operator.
  • The business name and mailing address of all locations where the supplement is manufactured, packaged, labeled, or stored.
  • A list of all ingredients in each supplement.
  • The number of servings per container.
  • Directions for use.
  • Warnings, notice, and safe-handling statements.
  • Allergen statements.
  • Any health or structure/function claims.
  • The dietary supplement product listing number.

The bill would make all information publicly available in a searchable electronic database, subject to limited exceptions.

Even though the bill made it out of committee, a significant hurdle, there’s no timeline yet for a vote in the full Senate.

Industry Condemns the Bill

The Council for Responsible Nutrition, which has pushed for a mandatory product listing for years, took issue with this iteration, insisting that it failed to include the necessary protections for industry stakeholders.

“As the industry’s leading proponent for a federal mandatory product listing program operated by FDA, CRN remains steadfast in our belief that such a program can provide consumers and the agency the transparency they want and need from the marketplace,” CRN President and CEO Steve Mister said in a press release. “However, that transparency does not require confidential business information to go unprotected and should not necessitate trading away assurances that the authority to create the listing will not be misused. Responsible industry invests millions of dollars each year in researching, developing, and testing — ingredient innovation that powers the $54 billion dietary supplement market. Leaving out these essential business protections will needlessly stifle that innovation.”

Mister added that his trade group would like to see some protections included in the legislation, such as:

  • Unwavering language that FDA may neither reject a submission nor create qualifications on submissions that would permit the agency to reject a listing.
  • Protections for confidential or proprietary business information from public release.
  • Limits on the information provided to FDA to those items that appear on the label.
  • No creation of broad, new prohibited acts that could have unintended consequences for the industry.

The American Herbal Products Association also quickly opposed the bill, saying it would create “unnecessary, significant, and redundant burdens on industry.”

The Natural Products Association (NPA) also objected to the bill.

“We are disappointed that the significant economic, consumer, and security-related concerns raised by NPA, other experts, and thousands of American constituents, have to this point, appear to have fallen on deaf ears,” NPA President and CEO Dr. Daniel Fabricant said. “We will redouble our efforts to continue educating members and staff about the deep negative impact of these provisions in hopes that we can get a fair hearing as the legislative process unfolds.”

An Industry Bogeyman

The FDA has included requests for a mandatory product registry in its annual budget proposals for several years. According to the latest request, “This proposal would require all products marketed as ‘dietary supplements’ to be listed with FDA and give FDA authority to act against non-compliant products and the manufacturers and/or distributors of such products. This would allow the FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, improve transparency, and promote risk-based regulation.”

Even though the threat of a mandatory product registry has cast a shadow over the dietary supplement business for years, there’s already a voluntary, self-regulated database, the Supplement OWL (Online Wellness Library), in place. The Council for Responsible Nutrition (CRN) launched the database in 2017, which “serves as a resource for consumers, businesses, and regulators to identify products, their ingredients, and the companies who market them, and permit registry users to examine and evaluate labels and other product information.”

CRN’s OWL database includes data on more than 9,000 individual labels. OWL entries include a product image, label, and various data fields, such as ingredients, dosage form, label claims, and contact information. CRN requires companies to submit their labels and provide manufacturing and packaging facility contact information, accessible only to the FDA.

“Broad industry participation in the Supplement OWL is critical,” CRN Vice President of Scientific and Regulatory Affairs Luke Huber explained. “This self-regulatory initiative serves as a model for mandatory product listing, proposed by FDA and supported by CRN and other responsible stakeholders in the industry.”

Trade groups such as CRN and the Dietary Supplements Quality Collaborative (DSQC) support the idea of a mandatory product registry – in theory.

“The FDA doesn’t really have a way to know what’s out there [in the market], and it’s hard to regulate what you can’t see,” DSQC Chair Christine Burdick-Bell told Natural Products Insider.

Consumer groups, such as the Center for Science in the Public Interest (CSPI), have also pushed for a mandatory product registry.

“The FDA should require mandatory product listing and registration so that it can track dangerous products and repeat offenders, identify hazards in dietary supplements, and anticipate safety issues,” CSPI Director of Strategy and Program Laura MacCleery said in a recent webinar. “This should include important safeguards so that products that are not legal to bring to market are not listed, and retailers must verify the registration via a QR code.”

Industry supporters insist a registry would:

  • Build a more robust marketplace of responsible companies.
  • Make it easier for consumers to recognize trustworthy products.
  • Help regulators identify products in a crisis.
  • Encourage compliance with Good Manufacturing Practices (GMPs).
  • Shore up the industry’s reputation with critics.

Critics, however, counter that:

  • It would impose an undue burden on companies, especially smaller operators.
  • The FDA doesn’t do enough to enforce the regulations already in place.
  • Regulators would take advantage of the database to turn it into a tool for premarket review.
  • It would serve as a launchpad for plaintiffs’ attorneys eager to pursue class-action suits.

Industry stakeholders admit that it’s not a matter of if but when regulators impose a mandatory product registry. And the best way to prepare for that eventuality is to embrace digital records management, which will make any transition to a national registry much easier.

“Mandatory product registration is a good start and would help to catch us up with the rest of civilization,” Alkemist Labs CEO Elan Sudberg wrote in a blog post. “Yes, it’d be painful, but it’d also be extra painful for those unscrupulous players we’re trying to remove.”