FDA Publishes Updated SPL Implementation Guide with Validation Procedures

Yesterday FDA published an updated  Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, including updates to cosmetics product facility registrations and product listings that are now included within the SPL framework.

Yesterday’s release updates the SPL Implementation Guide published by FDA on October 13, 2023, which included facility registrations and product listings within the SPL framework, and described  the soon-to-be-released Cosmetics Direct electronic submission portal function as an SPL authoring tool intended to feature user friendly data entry forms, perform initial validations, create and save SPL submissions, and submit the SPL forms to FDA for internal processing.

Noteworthy changes to the required technical conformance criteria include:

    • Clarification of initial versus updated cosmetic product coding;
    • Clarification of coding requirements for human OTC drugs that are also cosmetic products;
    • Clarification between “leave-on” versus “rinse-off” product coding, unless the document type is a Cosmetic Facility Registration;
    • Clarification of cosmetic product category and cosmetic product facility codes;
    • Reclassification of “feminine deodorants” as “other personal cleanliness products”;
    • Clarification of market status coding as to discontinued or soon-to-be discontinued cosmetic products; and
    • Replacement of “Registrant” information with “Authorized Agent” information.

FDA has not yet announced when it expects the Cosmetics Direct portal to go live, but anticipates it being available for companies to register facilities and list products sometime before year end.

 

FDA Issues Update On Ongoing Cosmetic Product Facility Registration and Product Listing Under MoCRA

Today, FDA announced that it is effectively pushing back its anticipated October launch date for electronically submitting cosmetic product facility registration and product listing information required by the Modernization of Cosmetics Regulation Act (MoCRA).

MoCRA requires any facility that manufactures or processes cosmetic products intended for sale in the United States—irrespective of whether the facility is located in the United States—to register with FDA, and further requires manufacturers, packers, and distributors of cosmetics intended for sale in the United States to submit to FDA lists of products and ingredient information. The statutory deadline for facility registration and product listing is December 29, 2023.

FDA has previously stated that it expected its newly developed draft electronic submission portal–Cosmetics Direct–to begin accepting submissions in October 2023, in advance of the year-end deadline.

Today, however, FDA advised that it will provide more information on the launch date for electronic submission and paper submission forms “in the coming weeks.”

FDA advised that “[i]ndustry can continue to prepare for registration and listing by reviewing the documents FDA has provided and being proactive in collecting the information required to complete their facility registrations and product listings.”

FDA’s announcement comes after its issuance of draft guidance in August 2023, which, when finalized, will provide recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.

FDA also solicited comments on Cosmetics Direct in its draft form, as well as the proposed paper forms (Forms FDA 5066 and 5067). The comment period is now closed, and FDA is in the process of obtaining approval from the Office of Management and Budget (OMB) in the Executive Office of the President, under the Paperwork Reduction Act for the proposed collection of registration and listing information, as well as concluding beta-testing of Cosmetics Direct.

In October 2023, FDA also announced publication of the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures,  which can be used to develop SPL authoring tools and generating SPL-formatted submissions for cosmetic product facility registrations and product listings.

FDA will continue to provide updates on its MoCRA rollout, and until then, stay tuned for additional MoCRA updates.

 

 

 

New York Federal Court Dismisses Putative Class Action Suit Alleging Deceptive Marketing Of PFAS-Containing Mascaras

On September 30, 2023, the US District Court for the Southern District of New York dismissed a putative class action in which plaintiffs claimed they would not have purchased or paid a premium price for certain waterproof mascaras had they known of the presence of per- and polyfluoroalkyl substances (“PFAS”).

In a 22-page opinion, the court held that plaintiffs failed to sufficiently allege that the mascaras they individually purchased actually contained PFAS, or that there was a material risk that they did; thus, plaintiffs could not establish an actual injury.

The court dismissed plaintiffs’ claims under Sections 349-50 of New York’s General Business Law, as well as a host of other state consumer protection laws, and common law claims for unjust enrichment, breach of express and implied warrant, and fraudulent concealment.

Notably, the court rejected plaintiffs’ attempts to establish actual injury by relying on a 2021 study conducted by researchers at the University of Notre Dame, which screened 231 cosmetic products, including lip products, eye products, foundations, face products, mascaras, concealers, and eyebrow products, for their total fluorine levels to identify the possible presence of PFAS, as well as specially commissioned third party analysis of the waterproof mascaras purchased by plaintiffs.

The court concluded that the mascaras purchased by plaintiffs weren’t analyzed in the Notre Dame Study; moreover, the court identified “glaring shortcomings” with plaintiff’s’ third party analysis, noting that the study “does not allege, for instance, how many products were tested … whether all those tested products revealed the presence of PFAS, and if not, what percentage of the products had PFAS.”

Although plaintiffs are seeking to amend their complaint to revive their claims, the takeaway here is, following the U.S. Supreme Court’s decision in TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2207 (2021), absent an actual injury, plaintiffs will not have standing to pursue class action claims.

It’s important to note that hovering in the background of cosmetics-related PFAS litigation is the recent Modernization of Cosmetics Regulation Act (“MoCRA”), which overhauled federal regulation of cosmetics in the United States. Among its many new rulemaking requirements, MoCRA requires FDA to publish a report no later than 2025 assessing the use of per- and polyfluoroalkyl substances (PFAS) in cosmetics and safety risks associated with such use. It remains to be seen what effect FDA’s report will have on putative PFAS class actions in the beauty and wellness space, and what, if any, defenses cosmetics companies can assert based on FDA’s analysis.

The case is Zaida Hicks, et al. v. L’Oréal USA Inc., No. 22-1989, (S.D.N.Y. Sept. 30, 2023).

 

MoCRA Requires Federal Regulatory Overhaul

On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)—the first major statutory change to the U.S. federal government’s ability to regulate cosmetics since 1938. Passed with bipartisan
and industry support, MoCRA expands the Food and Drug Administration’s authority over cosmetics, and creates substantial new obligations for manufacturers, packers and distributors of cosmetics intended for sale in
the United States. Here’s what beauty companies need to know.

To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website,

FDA Issues Long-Awaited Draft Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products Under MoCRA

MoCRA’s long-awaited rollout continues as today FDA released draft guidance to assist persons submitting cosmetic product facility registrations and product listings under newly-added Section 607 of the federal Food, Drug, and Cosmetic Act (FD&C Act).

Background

Section 607(a) of the FD&C Act requires every person that owns or operates a facility that “engages in the manufacturing or processing of a cosmetic product for distribution in the United States” to register each facility with FDA, update content within 60 days of any changes, and renew their registration every two years.

As of March 27, 2023, FDA ended its voluntary cosmetics registration program (VCRP), and advised that information submitted to VCRP would not be transferred over to any new system.

Section 607(c) of the FD&C Act further requires that for each cosmetic product, the responsible person must submit to FDA annually “a cosmetic product listing,” including ingredients. 

MoCRA defines a “responsible person” as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act (FPLA).

Key takeaways from Today’s FDA Draft Guidance:

Small Business Exemption: Small businesses, as defined by Section 612 of the FD&C Act (average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1 million, adjusted for inflation, and who do not manufacture or process certain cosmetic products described in Section 612(b)), are not required to register facilities and list cosmetic product(s).

Electronic Submission Portal: FDA’s new electronic submission portal is expected to be available in October 2023, with FDA strongly encouraging electronic submissions. FDA is developing a paper form as an alternative submission tool.

Definitions: The Draft Guidance defines “contract manufacturer,” “cosmetic products,” “facility,” “manufacturing or processing,” “operator,” “owner,” “responsible person,” and “small business.”

Who Makes the Submissions: Every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States to register each facility and submit a cosmetic product listing unless:

    • it is exempt as a “small business”; or
    • the cosmetic product is also a drug or device subject to the requirements of Chapter V of the FD&C Act.

What Information to Include (Registration):

    • the name of the owner and/or operator of the facility;
    • the facility’s name, physical address, email address, and telephone number;
    •  with respect to any foreign facility, the contact for the United States agent of the facility (name and phone number), and, if available, the electronic contact
      information (email);
    • the facility registration number, if any, previously assigned;
    • all brand names under which cosmetic products manufactured or processed in the facility are sold;
    • the product category or categories (listed in Appendix A of the Draft Guidance) and responsible person for each cosmetic product manufactured or processed at the facility; and
    • type of submission (initial, amended, biennial renewal, or abbreviated renewal)

FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. The e owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.

FDA also requests that the following additional optional information be submitted:
• parent company name (if applicable);
• facility DUNS Number; and
• additional contact information for individuals associated with the registration.

What Information to Include (Product Listing):

    • the facility registration number of each facility where the cosmetic product is manufactured or processed;
    • the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
    • the applicable cosmetic category or categories for the cosmetic product (listed in Appendix A of the Draft Guidance)
    • a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient;
    • the product listing number, if any previously assigned; and type of submission (initial, update to content (annual), abbreviated renewal)

FDA also requests that the following additional optional information be submitted:

    • parent company name (if applicable);
    • type of business (as listed on the label), i.e., manufacturer, packer, or distributor;
    • image of the label;
    • product webpage link;
    • whether the cosmetic product is for professional use only;
    • Responsible person DUNS Number (Dun & Bradstreet number) for address listed on product label;
    • Unique Ingredient Identifiers (UNIIs); and
    • additional contact information for individuals associated with the listing.

Multiple Listings: Under Section 607(c)4()B), a single listing for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents

Attestation: FDA requests that individuals submitting registration and listing information to attest to the accuracy and veracity of the information submitted.

How/When to Submit: Stakeholders should plan to register and list in advance of the December 29, 2023 statutory deadline.

Fees: There is no fee to submit a registration or product listing to FDA under section 607 of the FD&C Act.

Public Disclosure: Under section 607 of the FD&C Act, FDA will not disclose information from a facility registration on the brand names under which cosmetic products manufactured or processed in the facility are sold, or from a product listing on the facility registration number of the facility where the cosmetic product is manufactured or processed, in response to a request under the Freedom of Information Act (FOIA) (5 U.S.C. 552).

All other information from cosmetic product facility registration and listing would be available for public disclosure consistent with the FOIA, FDA’s disclosure regulations under 21 CFR Part 20, and other applicable federal law.

Drugs AND Cosmetics?: Cosmetic products that are also drugs under Chapter V of the FD&C Act are not subject to listing requirements. Likewise, a facility that manufactures or processes cosmetic products that are also drugs is not subject to registration requirement  unless it also manufactures or processes cosmetic products that are not also drugs.

Enforceability: As a reminder,  FDA’s guidance documents do not establish legally enforceable responsibilities, but are intended to describe FDA’s current thinking and should be viewed as recommendations.

Conclusion

Today’s Draft Guidance provides much-needed clarity regarding MoCRA’s requirements and upcoming registration and listing deadlines. However, we expect further guidance in the upcoming months as to MoCRA’s additional December 2023 deadlines, and feedback with FDA regarding any flexibility in meeting these deadlines.

 

Post-MoCRA Regulatory Compliance Checklist for Beauty and Personal Care Products

MoCRA, Pub. L. No. 117-328, represents the first major statutory change to the authority of the Food and Drug Administration (FDA) to regulate cosmetics since the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 361 et seq.,
in 1938 and the Fair Packaging and Labeling Act (FPLA), 21 C.F.R. § 701.3, in 1966.

This checklist outlines key regulatory compliance considerations that are specific to personal care products marketed in the United States following the enactment of the federal Modernization of Cosmetics Regulation Act (MoCRA) on December 23, 2022.

To read the full text of this Lexis Nexis Practical Guidance Checklist by Duane Morris attorneys Driscoll UgarteRick BallAlyson LotmanKelly Bonner and Coleen Hill, please visit the firm website.

US FDA Seeks Head of Human Foods, Looks to Move Cosmetics Work

Duane Morris attorney Kelly Bonner was quoted in an article in Chemical Watch on March 3.

“The US Food and Drug Administration has started its search for a deputy commissioner for its new human foods programme, and plans to move certain cosmetics functions to another part of the agency to advance oversight of the products. […]

The inclusion of cosmetics in the proposed restructuring is “very significant”, said Kelly Bonner, associate with law firm Duane Morris. Continue reading “US FDA Seeks Head of Human Foods, Looks to Move Cosmetics Work”

Sephora Disputes “Misleading” Allegations in Clean Beauty Class Action Lawsuit

Introduction

On March 2, 2023, Sephora filed its reply in support of its motion to dismiss proposed class action claims that its “Clean at Sephora” program was false and misleading, disputing allegations that a significant portion of relevant, reasonable consumers were or could be misled about what ‘Clean at Sephora’ means, and that the ingredients permitted by Sephora’s program were potentially harmful to humans.

Sephora’s reply (presumably) concludes preliminary briefing in what has become a closely-watched lawsuit in the beauty and wellness industry over the meaning of the term “clean beauty.”[1] Absent clear regulatory guidance from the FDA and the FTC, companies’ claims involving the terms “clean,” “natural,” “nontoxic,” or “organic” have been scrutinized in social media, and by an increasingly active and organized plaintiffs’ bar.

While it remains to be seen how the court will decide the “Clean at Sephora” case, companies should continue expect more litigation in this area, as what it means for beauty products to be clean, natural, nontoxic, or safe, remains the subject of intense debate. 

Case Background

As explained in our previous publications (here, here, and here), the market for clean beauty is expected to reach an estimated $11.6 billion by 2027.[2] But absent clear regulatory guidance about what it means for beauty products to be “clean,” “natural,” “nontoxic,” or “safe, promoting products as “clean” can carry significant regulatory risks, and leaves the industry ripe for class action litigation.

Sephora launched its “Clean at Sephora” program in 2018.[3] To qualify for inclusion in the program, which spans across various product categories, products must be formulated without certain common cosmetic ingredients—such as parabens, sulfates SLS and SLES, phthalates, formaldehyde and more—that are linked to possible human health concerns.[4]

On November 22, 2023, Plaintiff Lindsay Finster filed a proposed class action lawsuit in the U.S. District Court for the Northern District of New York, alleging that products advertised as part of the “Clean at Sephora” program contain ingredients that are “inconsistent with how consumers understand” the term “clean.”[5]

According to plaintiff, consumers understand the definition of “clean” beauty to mean the dictionary’s definition of “clean”: “free from impurities, or unnecessary and harmful components, and pure.”[6] Thus, to be considered “clean” in the context of beauty, plaintiff alleged that products should be “made without synthetic chemicals and ingredients that could harm the body, skin or environment.”[7] But, as plaintiff contended, “a significant percentage of products with the ‘Clean at Sephora’ [seal] contain ingredients inconsistent with how consumers understand the term.”[8] Consequently, plaintiff alleged that the “Clean at Sephora” program “misleads consumers into believing that the products being sold are “natural,” and “not synthetic” and to paying a price premium based on this understanding.”[9]

Plaintiffs alleged potential class action violations of §§ 349 and 350 of New York’s General Business Law (“NY GBL”), as well as multi-state consumer protection statutes, and breach of express and implied warranty, the Magnuson Moss Warranty Act, fraud, and unjust enrichment claims.[10]

Sephora’s Motion to Dismiss

On February 2, 2023, Sephora moved to dismiss plaintiff’s complaint, arguing that “[i]t is not plausible that reasonable consumers are or could be confused by the ‘Clean at Sephora’ program” for several reasons.[11]

First, Sephora argued that plaintiff relied on unsupported and conclusory allegations about consumers understanding of the word “clean.”[12] While plaintiff argued that consumers understood the definition of “clean” beauty to mean the products made without synthetic chemicals and or potentially harmful ingredients, Sephora countered that plaintiff failed to plead any facts showing that a significant portion of relevant reasonable consumers could be misled by Sephora’s claims into believing that the “Clean at Sephora” program consisted of only natural products and ingredients.[13] As Sephora noted, words like “natural,” “organic,” and the like never appeared on the label or elsewhere.[14] Instead, plaintiff relied upon “on selectively quoted blog posts and webpages from small businesses, which not only lack reliability and authority but are presented without evidence that any significant number of consumers have even read them, let alone agreed with them.”[15]

Second, Sephora argued that plaintiff mischaracterized Sephora’s representations as being about the kinds of ingredients included in the program, rather than excluded.[16] Thus, plaintiff was attempting to turn “Clean at Sephora” into “Natural at Sephora”—claims that Sephora did not make.[17] On the contrary, Sephora’s marketing for the program focused on the exclusion of certain ingredients linked to potential human health outcomes.[18] Because Sephora made no representations about the products or ingredients included, it argued that it could not mislead consumers about the safety of included products or ingredients in the program.[19] Moreover, plaintiff failed to plausibly allege that any of the ingredients included in the program were potentially harmful, relying instead on a series of unattributed and unsubstantiated blog posts.”[20]

Finally, Sephora rejected plaintiff’s contention that it forced consumers to scrutinize product lists in contradiction of the Second Circuit’s 2018 decision in Mantikas v. Kellogg, which prohibits the use of ingredient lists on the side of packaging to clarify otherwise misleading presentations where plaintiff failed to identify any misleading conduct by Sephora.[21]

Sephora also rejected plaintiff’s efforts to seek relief under other unspecified consumer protection statutes, arguing that plaintiff failed to plead how the unspecified consumer protection statutes were similar to the NY GBL,[22] and disputed plaintiff’s breach of warranty, consumer fraud, and unjust enrichment claims as duplicative of plaintiff’s NY GBL claims, or otherwise contingent on the same erroneous premise—that the ‘Clean at Sephora’ label is misleading—and thus, equally deficient.[23]

In opposition to Sephora’s motion to dismiss, plaintiff reiterated that it was sufficiently plausible that reasonable consumers would perceive the “Clean at Sephora” as excluding synthetic ingredients, and that “Clean at Sephora” meant free from potentially harmful ingredients.[24] Plaintiff further contended that resolution of her multi-state claims was not ripe until the class certification stage,[25] and that Sephora’s advertising campaign created an express warranty that “Clean at Sephora” products were formulated without potentially harmful ingredients.[26]

In its reply, Sephora argued that reasonable consumers could not interpret the phrase “Clean at Sephora” as limited to only “natural” ingredients when Sephora “prominently explains, in plain terms, exactly what it means by the phrase: ‘formulated without parabens, sulfates sodium lauryl sulfate (SLS) and sodium laureth sulfate (SLES), phthalates, mineral oils, formaldehyde, and more.’”[27] Sephora also refuted plaintiff’s efforts to characterize the program’s inclusion of the phrase “and more” into an impression that synthetic ingredients were excluded along with the listed ingredients, noting that plaintiff alleged no facts to support her contention that reasonable consumers shared that impression. [28]

Finally, Sephora rejected what it described as plaintiff’s efforts to conflate the meaning of the word “clean” with “non-synthetic” or “natural,” or otherwise assert that because products are not “natural,” they were not safe, noting that not all synthetic ingredients were unsafe, while not all natural ingredients were safe. [29]

Takeaways

Although the recent Modernization of Cosmetics Regulation Act (MoCRA), which was passed by Congress on December 23, 2022, significantly expands FDA’s authority over cosmetics, it provides comparatively little guidance on the kinds of marketing or promotional claims brands can make about the safety or purity of their products. Consequently, these issues are expected to remain the subject of intense scrutiny and costly litigation.

It remains to be seen how the court will rule in the “Clean at Sephora” case. Nevertheless, this case remains closely-watched within the beauty and wellness industry, and we will continue to update you as the case develops.

[1] See Sephora’s Reply in Support of Motion to Dismiss (“Reply”) at 1, Finster, et al, v. Sephora USA, Inc., No. 6:22-cv-1187 (GLS/ML) (N.D.N.Y.), Mar. 3, 2023 (Dkt. No. 18).

[2]Cosmetics Companies Invite Legal Risks With ‘Clean’ Marketing,” Law360, September 1, 2022

[3] https://www.gcimagazine.com/brands-products/news/news/21853297/sephora-launches-clean-at-sephora

[4] Sephora Clean Beauty Guide, https://www.sephora.com/beauty/clean-beauty-products

[5] Complaint (“Compl.”) at ¶ 15, Finster, et al, v. Sephora USA, Inc., No. 6:22-cv-1187 (GLS/ML) (N.D.N.Y.), Nov. 11, 2022 (Dkt. No. 1).

[6] Id. at ¶ 2.

[7] Id. at ¶ 2-4.

[8] Id. at ¶ 15.

[9] Id. at ¶ 35.

[10] Id. at 6-10.

[11] Motion to Dismiss at 1, Finster, et al, v. Sephora USA, Inc., No. 6:22-cv-1187 (GLS/ML) (N.D.N.Y.), Feb. 2, 2022 (Dkt. No. 6-1).

[12] Id. at 7-8.

[13] Id.

[14] Id.

[15] Id. at 9.

[16] Id. at 1.

[17] Id. at 7-8.

[18] Id.

[19] Id. at 10-11.

[20] Id. at 11-12.

[21] See 910 F.3d 633, 636–37 (2d Cir. 2018).

[22] Id. at 14.

[23] Id. at 15-19. Sephora also advanced several pleading deficiency arguments, including plaintiff’s failure to allege the product was advertised as “free from defects” as required by the Magnuson Moss Warranty Act.

[24] See Opposition to Sephora’s Motion to Dismiss (“Opp.”) at 4 (Feb. 23, 2023) (Dkt. No. 15).

[25] Id. at 7.

[26] Id. at 8.

[27] See Reply at 3.

[28] Id.

[29] Id. at 4.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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