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Enforcement Edge
May 15, 2023

Safer Choice: Will EPA Be Certifying FDA-Regulated Products?

Enforcement Edge: Shining Light on Government Enforcement

Environmental Protection Agency (EPA) officials recently announced that they are considering expanding a voluntary program under which EPA reviews and certifies “safer” household products to also cover personal care products primarily regulated by the Food and Drug Administration (FDA).

The “Safer Choice” program presently covers a wide range of products, including glass cleaners, general purpose cleaners, washroom cleaners, carpet cleaners, laundry detergents, graffiti removers, boat and car care, drain cleaners, and floor care and other industrial products.

Background

The Safer Choice program dates back to the 1990s, when the EPA’s Design for the Environment (DfE) program was launched. It began as an initiative to help companies better consider human health, environmental and economic effects of chemicals and technologies, and product performance when designing and manufacturing their products. In the mid-2000s, EPA developed a product certification program that allows companies to add “Safer Choice” to their labels after approval (or “DfE Safer Product” before 2015).

Under the Safer Choice approval process, EPA evaluates every chemical, regardless of percentage, in a Safer Choice-certified product. Only the ingredients that EPA has determined are the “safest” may be present. The Safer Choice Standard that the EPA uses has human health and environmental criteria as well as specific criteria for individual component class ingredients, like surfactants, solvents, and chelants. Additionally, the product as a whole has to meet safety criteria, qualify as high performing, and be packaged in an environmentally friendly manner. As a condition of using the Safer Choice label, EPA requires that all ingredients must be disclosed either on the product or the manufacturer’s website.

Based on the reviews it has completed, EPA developed the Safer Chemical Ingredients List, which contains over 950 chemicals that meet Safer Choice criteria. Companies can use this list when developing products to help ensure that new products can meet the “Safer Choice” standard.

One advantage of the Safer Choice Label is preference in federal procurements. Executive Order 13693 directs federal agencies to select Safer Choice-certified products whenever possible. Additionally, Safer Choice status also is mandated by many state and municipal purchasers and is included in the standard for maintenance in green buildings.

Expansion to Personal Care Products?

EPA’s announcement that it is exploring ways to expand the program to products regulated by FDA marks a potentially significant expansion of EPA’s reach in the chemical approval space. It remains to be seen how such an expansion would work, as FDA clearly has more expertise than EPA in assessing personal care products, including safety of the product as a whole as well as product performance.

That being said, in a world where consumers’ interest in the chemicals in their personal care products is increasing, some manufacturers and advertisers may value the chance to have their products certified as “Safer Choice.” If the opportunity becomes available, companies considering using the certification, however, still should ensure such use is consistent with the FTC’s Green Guides.

For example, the Safer Choice certification may serve as a useful basis for companies to make environmental marketing claims about their personal care products, as the Safer Choice Standard evaluates environmental criteria and requires that product packaging meet certain sustainability criteria. That being said, under 16 C.F.R. § 260.6 of the Green Guides, the “use of an environmental certification or seal of approval likely conveys that the product offers a general environmental benefit . . . if the certification or seal does not convey the basis for the certification or seal.” Against this backdrop, use of the Safer Choice certification could trigger liability if it is used in a way that the FTC or court considers to convey a broader environmental benefit than can be supported. The FTC previously has shown it that it will go after personal care companies for falsely conveying that a claim is certified by a government agency when the claim is not. The FTC has also pursued enforcement against consumer product companies for allegedly referencing a government approval or certification in a manner that overstated the significance and scope of the actual agency approval or certification.

For questions about this post, Safer Choice certification, or the FTC Green Guides, please reach out to the authors.

© Arnold & Porter Kaye Scholer LLP 2023 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.