Federal Legislation Would Deem 15 Chemicals Unsafe in Food Packaging

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On June 9, 2026, lawmakers introduced the No Toxic Chemicals in Food Packaging Act of 2026, which would ban 15 chemicals or chemical classes—including PFAS, ortho-phthalates, and bisphenol A—from food-contact use.  H.R.9231 was introduced by Rep. Jan Schakowsky (D-IL) and Rep. Rosa DeLauro (D-CT) and has been referred to the House Committee on Energy and Commerce.  The Senate companion, S.4724, was introduced by Sen. Richard Blumenthal (D-CT) and has been referred to the Senate Committee on Health, Education, Labor, and Pensions.

Similar legislation was introduced in 2023, but that bill covered fewer substances and did not advance out of committee.

What the Bill Does

The bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) § 409 (21 U.S.C. § 348) by adding a new subsection (l) that deems 15 chemicals or chemical classes unsafe for use as food contact substances.  That designation is cross-referenced against FFDCA § 402(a)(2)(C), the adulteration provision, meaning food packaged or processed using these substances would be treated as adulterated under existing law.

The bill covers the following substances:

  • Any chemical belonging to the class of ortho-phthalates
  • Any chemical belonging to the class of PFAS
  • Bisphenol A, B, S, F, or AF or related compounds
  • Acrolein
  • Acrylamide
  • BHA (tert-Butyl-4-hydroxyanisole)
  • Chlorinated paraffins
  • 1,4-Dioxane
  • Asbestos
  • Benzene
  • Chloroform
  • Methylene chloride
  • Ethylene oxide
  • Formaldehyde
  • Styrene polymers

Three drafting choices are worth flagging.  First, a new subsection (l)(2) directs FDA to weigh potential adverse effects on “vulnerable populations”—defined broadly to include infants, pregnant women, workers, and residents of disproportionately exposed communities—when evaluating substitute substances proposed as alternatives to the banned fifteen.

Second, the bill includes an express savings clause preserving state and local authority to regulate food additives, including authority more stringent than the federal floor.  That non-preemption choice is notable given the growing number of states that have restricted or are considering restricting certain additives.

Third, the legislation expansively defines PFAS as any substance containing at least one fully fluorinated methyl or methylene carbon atom, which closely resembles the most recent Organisation for Economic Co-operation and Development (OECD) definition.

The new subsection would take effect two years after enactment, per the bill’s delayed-applicability clause.

Why It Matters Now

The bill arrives while FDA is already facing litigation pressure on two of the chemical classes it targets.  A coalition of advocacy groups is challenging FDA’s 2022 denial—reaffirmed on reconsideration in October 2024—of a petition to revoke authorizations for 28 ortho-phthalates, in litigation now pending before the D.C. Circuit.  Separately, a citizen petition seeking PFAS tolerances in food is the subject of an Administrative Procedure Act suit in the District of Arizona, where the court has continued proceedings pending FDA’s response.  As of this writing, neither matter has produced a ruling on the merits, and both postures could change before this bill reaches markup.

FDA has also launched a reassessment of one of the affected substances, BHA, on its own initiative.  The review, announced in February, will consider whether BHA is safe under its current conditions of use in food and as a food contact substance.  In addition, over a dozen states have already enacted prohibitions on the use of PFAS in food packaging.

Who’s Affected

Food and beverage manufacturers, packaging converters (particularly PFAS-treated paper and fiber products and phthalate-plasticized flexible packaging), and upstream chemical suppliers face the most direct reformulation exposure.  Grocery, retail, and food service companies would also inherit supply-chain risk from upstream suppliers.

GRAS Reform Update: Where Do Things Stand?

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For decades, food manufacturers have relied on a regulatory pathway known as Generally Recognized as Safe—or GRAS—to introduce substances into the food supply without formal FDA approval.  Under this framework, a substance may bypass the agency’s premarket review process if qualified experts generally recognize it as safe for its intended use.  That practice is now under increasing scrutiny, and the GRAS framework has become the focus of a rapidly developing reform effort at the federal and state levels.

Background

The Federal Food, Drug, and Cosmetic Act (FFDCA) requires premarket review and approval of any substance intentionally added to food as a food additive, unless the substance is GRAS or otherwise excepted from the definition of a food additive.  Historically, FDA affirmed substances as GRAS on its own initiative or by petition.  Today, that responsibility largely rests with industry.

Companies may voluntarily submit a GRAS notification to FDA, which may respond that there is insufficient basis for a GRAS conclusion or issue a “no questions” letter leaving the determination unchallenged.  But this is not required: FDA regulations also allow a company to “self-affirm” a substance as GRAS without notifying the agency, allowing it to enter the food supply without FDA premarket review.

Closing this self-affirmation “loophole” has become a priority for federal officials, lawmakers, and advocacy groups.  FDA, Congress, and state legislators are all pursuing reform, as described below.

FDA Actions

FDA is developing a proposed rule to eliminate self-affirmed GRAS by mandating GRAS notification for substances purported to be GRAS.  The proposal is expected to exempt substances listed or affirmed as GRAS for the intended use by regulation, or for which FDA has issued a no questions letter.  It would also require FDA to maintain a public-facing GRAS inventory and clarify the process under which FDA would determine that a substance is not GRAS.

The Office of Management and Budget has been reviewing the proposed rule since December 1, 2025.  FDA leadership reportedly projects publication late this spring or early summer of this year.

In parallel, FDA is working to implement a post-market review program for substances already in the food supply, including those designated as GRAS.  Historically conducted on an ad hoc basis, these reviews are expected to follow a structured prioritization framework.  FDA released a draft framework for public comment last summer.

As part of that effort, this March, FDA launched a post-market review of butylated hydroxyanisole (BHA) by publishing a request for information in the Federal Register.  BHA is a chemical preservative listed as GRAS and authorized as a direct food additive when used as an antioxidant.

Legal uncertainty remains.  In 2021, the Southern District of New York denied a challenge to FDA’s self-affirmed GRAS scheme brought by a coalition of NGOs, noting that it is “unclear whether FDA even has the authority to make GRAS notifications mandatory” under FFDCA.  “The remedy Plaintiffs seek lies with Congress,” the court said.

Federal Legislation

Perhaps anticipating that litigation may jeopardize FDA’s rulemaking, Congress has introduced at least three bills to eliminate self-affirmed GRAS.

2341 – Ensuring Safe and Toxic-Free Foods Act of 2025 (Sen. Markey, D-MA) would mandate GRAS notifications supported by scientific evidence, including for substances currently self-affirmed on the market, within two years of enactment. Although not highlighted in the bill’s accompanying materials, the legislation also appears to sunset the GRAS pathway altogether after that two-year period. It would require FDA to post notices for public comment, eliminate the GRAS pathway for new substances, exclude from GRAS eligibility substances that are carcinogenic or show evidence of reproductive or developmental toxicity, require FDA to review at least 50 GRAS notices per year until the backlog is cleared, and require FDA to reassess at least 10 food substances or substance classes every three years.

H.R. 4958 – GRAS Act (Rep. Pallone, D-NJ-6) would mandate GRAS notifications for new substances and new uses going forward, with notifications required to demonstrate that the weight of evidence shows the substance is neither carcinogenic nor associated with reproductive or developmental toxicity.  The bill would require a written “no objection” response from FDA before a substance may be used as GRAS, mandate a public comment period, require triennial reassessment of at least 10 food substances or substance classes, and authorize FDA to collect user fees.

3122 – Better FDA Act of 2025 (Sen. Marshall, R-KS) would require notifications within two years of enactment for currently self-affirmed substances and at least 120 days before first use for new substances. It would require FDA to maintain a public GRAS list and automatically approve a use as GRAS if FDA fails to respond within 180 days. The bill would also allow FDA to reevaluate a food additive upon petition, state request, or on its own initiative, and would require that reevaluations be conducted by career scientists rather than political appointees.

Two additional bills impose post-market review requirements without revising the broader GRAS framework.  H.R.4306 (Rep. Schakowsky, D-IL-9), would require FDA to reassess the safety of at least 10 food substances or substance classes every three years and suggests the first 10 substances for reassessment.  H.R.7291 (Rep. Lawler, R-NY-17), would assemble an interagency review board to reassess pre-2000 manufacturer GRAS determinations, including self-affirmations, and recommend revocation where safety has not been demonstrated.

All of these bills are currently pending in committee.  None have attracted a cosponsor from the opposing party.

State Legislation

Notably, none of the federal proposals includes preemption provisions, even as states move aggressively in this space.  Numerous states have enacted or are considering restrictions on specific additives, including West Virginia, whose ban on synthetic food dyes is currently being litigated.

Other states are targeting self-affirmed GRAS more directly.  Bills introduced in Pennsylvania, New Jersey, New York, and California would each require manufacturers of self-affirmed GRAS to report information supporting the determination to the state, which would be made publicly available online. Failure to report would render the additive unlawful for use in that state.

Pennsylvania and California would require the same information and data required as part of a federal GRAS notice.  Although New Jersey’s reporting requirement would apply only prospectively to new uses of an additive, the other three bills appear to also cover existing self-affirmed substances.

Additional provisions vary by state.  New York would ban three specific substances and prohibit the sale of foods containing certain synthetic color additives in public schools.  California would approve existing additives upon report submission, but would subject substances and uses introduced after July 1, 2027, to evaluation by state regulators with an opportunity for public objection.  California would also declare additives and dietary ingredients unsafe if they are found to induce cancer when ingested and require systematic post-market reviews.

Of these bills, only New York’s has passed a legislative chamber this session—the state senate, on March 23, 2026.  That bill, as well as Pennsylvania’s, has sponsors from both parties.

Verdant Law closely monitors these developments and their implications for the evolving regulation of food additives and the GRAS framework.  Please contact us with any questions.

Fourth Circuit to Review West Virginia Dye Ban Injunction

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The Fourth Circuit will decide whether a lower court properly paused enforcement of a West Virginia law banning certain FDA-approved synthetic color additives over concerns the statute is unconstitutionally vague.

The case arises from a 2025 West Virginia law designating seven color additives as “poisonous and injurious” and prohibiting their use in school nutrition programs—including six additives currently approved by FDA for use in food, drugs, or cosmetics.

On December 23, 2025, the Southern District of West Virginia issued a preliminary injunction, agreeing with a color additive trade association that identifying FDA-approved additives as “poisonous and injurious” rendered the law’s requirements unclear.

“[T]he inclusion of a list of FDA-approved color additives muddies the water and creates confusion as to what substances now constitute ‘poisonous and injurious,’” the court wrote.  Food additive makers “cannot predict what substances may be considered ‘poisonous and injurious’ when such a slim explanation exists for the named color additives,” leaving the door open for arbitrary enforcement, the opinion continues.

The court further emphasized that, because FDA has not determined six of the seven listed additives to be unsafe, “it is imperative that West Virginia define and, thereby, give necessary notice and guidance as to what constitutes ‘poisonous and injurious.’”

The trade association’s additional claims—that the statute constitutes an unconstitutional bill of attainder and violates the Equal Protection Clause—were rejected.  West Virginia officials filed a notice of appeal on January 22, 2026.

Although West Virginia has long barred the sale of adulterated food, including food containing ingredients deemed “poisonous or injurious to health,” it had not previously identified specific substances as meeting that undefined statutory standard.

Contested Additives

The seven color additives named by the statute are FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 3, FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6.  FDA has revoked authorization for FD&C Red No. 3 in food and ingested drugs, effective January 2027.  Only the six additives that remain FDA-approved are at issue in the litigation.

H.B. 2354 also names two preservatives, butylated hydroxyanisole (BHA) and propylparaben.  This month, FDA launched a reassessment of BHA’s safety, publishing a request for information on the use and safety of the substance.  BHA is currently listed as generally recognized as safe (GRAS).

The appellants, West Virginia officials from the Department of Health and Bureau for Health, must file their opening brief by March 4.  The trade association’s response is due April 3.

The case is International Association of Color Manufacturers v. Singh, No. 26-1085 (4th Cir.), appeal filed January 22, 2026.  The underlying case, No. 25-cv-588 (S.D. W. Va.), was filed October 10, 2025.

FDA Withdraws Asbestos Testing Proposal for Talc Cosmetics

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On November 28, 2025, in response to adverse comments, FDA published a notice announcing its withdrawal a December 2024 proposed rule that would have required manufacturers of talc-containing cosmetic products to test for asbestos.

The rulemaking is required by section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which directs FDA to “promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.”  FDA’s notice makes clear that the agency plans to issue a new proposed rule in the future.

FDA cites “Make America Healthy Again (MAHA) priorities to ensure safe additives in the American food and drug supply, the highly scientific and technical issues addressed in public comments the Agency has received, and the complexity of asbestos testing and legal considerations under the Administrative Procedure Act” as good cause for the withdrawal.

The concern underlying the rulemaking stems from the geological relationship between asbestos and talc.  According to FDA, asbestos is found in the same rock types that host talc deposits, which sometimes results in the presence of asbestos in talc cosmetics.

Although the testing requirements will not take effect, the Federal Food, Drug, and Cosmetic Act (FFDCA) continues to prohibit the sale of adulterated cosmetics, including those that contain “any poisonous or deleterious substance which may render [the product] injurious to users.”  FDA has previously taken action in this area: testing in 2019 led to recalls of talc cosmetics potentially containing asbestos, while testing in 2023 did not detect asbestos in any of fifty sampled products.

December 2024 Proposal

The December 2024 proposed rule would have required manufacturers to test talc-containing cosmetic products—or the talc ingredient before use—and maintain records demonstrating compliance. Manufacturers would have needed to test a representative sample of each batch or lot using both:

  1. Polarized Light Microscopy (PLM) (with dispersion staining).
  2. Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED).

Noncompliance would have rendered a cosmetic adulterated.  A talc cosmetic product would also have been deemed adulterated if any asbestos was present—even if only a single fiber was detected.

Issues Raised by Commenters

In the withdrawal notice, FDA notes several provisions of the proposed rule that were contested by commenters, including:

  • The proposed definition of “asbestos,” which differed from definitions used by OSHA, the Mine Safety and Health Administration (MSHA), and EPA.
  • Whether FDA has statutory authority to add a specific adulteration provision relating to talc testing or to deem any detectable asbestos as adulterating a cosmetic.
  • FDA’s inclusion of cosmetic products that are also drugs within the scope of the rule.

In addition, commenters raised concerns about the proposed test methods, although FDA did not address these in the withdrawal notice.  For example, the United States Pharmacopeia (USP) questioned whether TEM was superior to other test methods, arguing that it might yield more false positives.  USP also asserted that a single-fiber threshold for positive samples diverges from generally accepted TEM fiber counting procedures and would pose challenges for reproducibility.

More information on talc and asbestos can be found on FDA’s website.

FDA Defends Phthalate Food Additive Authorizations in Legal Challenge

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FDA acted reasonably when it denied a petition seeking to remove authorization for five phthalate chemicals used as food additives, the FDA told the D.C. Circuit on August 13, 2025.

The case, Alaska Community Action on Toxics v. FDA, No. 24-1382, marks the latest dispute over the safety of chemicals long used in food packaging and processing.  It centers on five phthalates—DCHP, DEHP, DINP, DIDP, and DAP—that remain approved for food use after industry voluntarily revoked authorizations for 23 other phthalates.  FDA denied the petitioners’ removal request in 2022 and overruled their objections in 2024, prompting the current appeal.

Decades-Old Safety Data

The petitioners argue that FDA’s denial ignores mounting evidence of phthalates’ hazards. “FDA’s authorizations rely on safety assessments conducted at least 40 years ago,” their March 28, 2025, opening brief states.  “In the intervening decades, the evidence of phthalates’ serious health risks—including their capacity to harm children’s brain development and cause life-altering changes in cognition and behavior—has expanded substantially.”  They contend that FDA “arbitrarily dismissed” evidence of toxicity and unsafe exposure levels.

In its opening brief, FDA contends that the petitioners have not established standing to bring the case.  Even the “most specific declaration…fails to provide any objective evidence of imminent harm,” and the petitioners’ brief fails to show “a ‘substantial probability’ their identified members will suffer specific health effects,” FDA states.

Burden of Proof

If the court reaches the merits, a key dispute will be which party bears the burden of proof.  The petitioners argue that the Federal Food, Drug, and Cosmetic Act (FFDCA) only requires “evidence that raises ‘significant questions as to the safety of the authorized uses,’” citing FDA’s 2016 revocations of three PFAS additives as precedent.  FDA counters that the petitioners are trying to “sidestep” their evidentiary obligations.  “Nothing in the statute supports an approach whereby repeal petitions benefit from vastly more lenient burdens than authorization petitions,” the agency’s brief states.

On the factual record, FDA maintains its denial rested on a “fair evaluation” and that its conclusions “about the lack of sufficient scientific data…merit substantial deference.”  The agency alleges flaws in the petition, including its “central premise” that phthalates could be treated as a class—but the petitioners argue that issue was mooted when industry revoked most phthalate authorizations.

A final question is whether FDA was required to hold an administrative hearing before overruling the petitioners’ objections to the petition denial.

More on FDA’s 2022 petition denial can be found in a previous post.

Are You Ready for Mandatory GRAS Notifications?

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The second Trump administration’s first Unified Regulatory Agenda of Federal Regulatory and Deregulatory Actions, published September 4, 2025, indicates that FDA is close to initiating a rulemaking to overhaul the generally recognized as safe (GRAS) regulations—a change that could significantly raise regulatory expectations for food manufacturers and ingredient suppliers.

What Does the Unified Agenda Say?

According to the unified agenda listing, “the proposed rule, if finalized, would amend the [GRAS] regulations…to require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.”  Substances that are listed as GRAS for the intended use by regulation, or have been granted a “no questions” letter by FDA, would be exempted.

The listing further notes that the rulemaking would clarify that FDA maintain and regularly update a public-facing GRAS notice inventory for all substances subject to the mandatory GRAS notice requirement for their intended uses.  It would also clarify the process by which FDA would determine that a substance is not GRAS.

The agenda indicates that a proposed rule is expected to be published in October 2025.

Putting It in Context

Under current regulations, companies can self-affirm that a substance—which includes ingredients as well as substances added indirectly (such as from food packaging)—is GRAS based on scientific evidence.  FDA’s GRAS notification program is voluntary; companies may notify FDA but are not required to.

The proposed rule would shift the system so that formal submission (notice) to the FDA becomes mandatory for most substances purported to be GRAS, except those already regulated or with prior FDA “no questions” letters.

The agenda listing follows Health and Human Services Secretary Robert F. Kennedy, Jr.’s March 2025 directive to FDA to explore revising the GRAS final rule and related guidance to eliminate the self-affirmation pathway.  “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again,” Secretary Kennedy said.

Environmental Groups Call on FDA to Revoke Approval of Fluorinated Plastic for Food Contact

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A coalition of environmental and health groups led by the Environmental Defense Fund have petitioned the Food and Drug Administration (FDA) to revoke approval of fluorinated polyethylene as an indirect food additive.  According to the petition, manufacture of fluorinated polyethylene produces PFAS, including harmful perfluoroalkyl carboxylic acids if water or oxygen is present.

FDA approved fluorinated polyethylene as an indirect food additive—a substance that comes into contact with food, but is not intended to be added directly to food—in 1983.  Since then, according to the petition, the dangers of even minimal exposures to PFAS have become clear, and studies have demonstrated that fluorinated polyethylene results in PFAS migration into food.

The petitioners argue that the substance can no longer be considered “safe” as defined at 21 CFR 170.3(i), which requires “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.”  The Agency must consider the following factors when determining whether this safety standard is met:

  • The probable consumption of the substance and any substance formed in or on food because of its use.
  • The cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in the diet.
  • Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food ingredients, are generally recognized as appropriate.

The petitioners also claim that revoking approval for fluorinated polyethylene is the logical consequence of a previous FDA statement on the substance.  In a 2021 public letter to manufacturers, distributors, and users of fluorinated polyethylene food contact articles, the Agency stated that its regulations “[do] not authorize fluorination of polyethylene containers in the presence of water, oxygen, or gases other than nitrogen.”  The petition, however, alleges that all nitrogen gas contains water and oxygen as impurities.  “If FDA is serious about its claim that no oxygen or water may be present in the nitrogen gas, then the agency has effectively determined that the 1983 approval should be revoked,” the petitioners state.

The petition comes after a July 2022 FDA request for information on food contact uses of fluorinated polyethylene due to PFAS concerns.

FDA Issues Draft Guidance for MoCRA Facility Registration and Product Listing

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The U.S. Food and Drug Administration (FDA) has released draft guidance, Draft Guidance for Industry: Registration and Listing of Product Facilities and Products, on the new regulatory requirements established in the Modernization of Cosmetics Regulation Act (MoCRA).  Among other provisions, MoCRA added section 607 to the Federal Food, Drug, and Cosmetics Act (FFDCA), requiring cosmetic product facility registration and cosmetic product listing.  The draft document details key registration and product listing requirements, including who must submit, what information is required, when registration and listings must be submitted, and how the FDA intends to accept registration and listing information.

All persons who own or operate a facility engaged in the manufacture or processing of a cosmetic product for distribution in the U.S. must register their facility.  Under MoCRA, a cosmetic product “means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”  FFDCA section 607(a)(1) provides two exceptions regarding who must register.  The first exception is for small businesses that have average gross annual sales of less than $1 million in the previous three years, unless they manufacture or process cosmetics that regularly come in contact with the mucus membrane of the eye, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours (and are not meant to be removed by the customer).  The second exemption is for facilities subject to the drugs and devices requirements under chapter V of the FFDCA, unless they also manufacture cosmetics that are not subject to the drug and device requirements.  The same exemptions apply for submission of product listing information.

Facility registration requirements are outlined in sections 607(a) and (b) of the FFDCA.  The requirements for facility registration include all brand names under which the cosmetic products manufactured or processed in the facility are sold and the product categories for each cosmetic product manufactured or processed in the facility.  Registrations must be submitted by December 29, 2023, for facilities that were manufacturing or processing cosmetic products on December 29, 2022.  Facilities that began manufacturing or processing after December 29, 2022, must register within 60 days of first engaging in that activity or by February 27, 2024, whichever date is later.  Registrations must be updated within 60 days of any changes to the registration information and must be renewed biennially.

Product listing requirements are outlined in FFDCA section 607(c) and include the facility registration number for each facility where the cosmetic product is manufactured or processed, its applicable cosmetic category or categories, and a list of product ingredients (including fragrances, flavors, or colors).  Listings must be submitted by December 29, 2023, for products that were marketed on December 29, 2022.  Products that were first marketed after December 29, 2022, must be listed within 120 days of marketing the product, or within 120 days of December 29, 2023, whichever date is later.  Any updates to the listing must be made annually.

Importantly, FDA clarified that any prior registrations through the Agency’s voluntary cosmetics registration programs will not be transferred to the new system; submitters will have to re-submit this information.

According to FDA, an electronic submission portal should be open for submissions beginning in October 2023, although a paper submission form is also available.

FDA Reaffirms Softening Chemicals are Okay for Food Packaging

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FDA recently denied a citizen petition requesting that the Agency prohibit the use of eight ortho-phthalates and revoke prior sanctioned uses for five additional ortho-phthalates in food packaging. Ortho-phthalates are used to soften plastics. They can be found in plastic film wrap on foods, cap gaskets used on the metal lids of glass jars, beverage caps, and other packaging.

The original petition was submitted by Earthjustice in 2016. FDA responded in May 2022, denying the petition; Earthjustice submitted a petition for reconsideration in June of that same year. Earthjustice stated that it filed the petition for reconsideration because FDA needed to consider the “mounting scientific evidence that phthalates in food cause serious harm,” evidence that has been developed since the petition was originally submitted.  According to Earthjustice, there is now significant scientific evidence that links phthalates to fibroid tumors in women and preterm births.

The petition for reconsideration alleged that FDA ignored the scientific information presented within the original petition, did not take new information into consideration when denying the petition, and failed to take action on the use of phthalates. In its response to the petition for reconsideration, FDA maintained that it did, in fact, assess the scientific information presented in the original petition, which it did not find persuasive enough to change its position on phthalate regulation at this time.

Further, under 21 CFR § 10.33, FDA is only required to grant a petition for reconsideration if all the following criteria apply:

(1) The petition demonstrates that relevant information or views contained in the administrative record were not previously or not adequately considered.

(2) The petitioner’s position is not frivolous and is being pursued in good faith.

(3) The petitioner has demonstrated sound public policy grounds supporting reconsideration.

(4) Reconsideration is not outweighed by public health or other public interests.

The Agency holds that no information was presented in the petition that has not already been presented and is, therefore, in the administrative record. Because all of the above requirements must be met for reconsideration without the presentation of new relevant information in the petition, FDA has no further obligation at this time.

Cosmetic Industry Increasing Supply Chain Ingredient Transparency

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The United States Congress has introduced a bill (H.R. 3622, The Cosmetic Supply Chain Transparency Act of 2023) to amend the Federal Food, Drug, and Cosmetic Act to increase transparency regarding the ingredients used in cosmetic and personal care products. Currently, cosmetic brand owners are not entitled to reliable and accurate information from their suppliers, formulating laboratories,  or the companies that package their products. Access to composition information and cooperation in gaining such information from these parties varies. However, despite limited access to supply chain data, brand owners are ultimately liable for the safety of the final products. Subsequently, brand owners are open to FDA enforcement actions, civil lawsuits, and marketplace reputational damage if safety issues with their products arise.

If passed, the bill will require upstream providers — from fragrance houses and formulating laboratories to contract manufacturers and suppliers of  raw materials and finished products — to  provide cosmetic companies with the following information upon request:

  • Full ingredient disclosure, including ingredient names and chemical identity numbers (Chemical Abstract Service or CAS)
  • Toxicity and safety data for each chemical ingredient
  • Certificate of analysis for raw materials
  • Environmental exposure and fate information
  • Heavy metal testing results
  • Safety data sheets
  • Manufacturing flow charts
  • Composition statements
  • Fragrance allergen statements
  • International Fragrance Association (IFRA) Standards Conformity Certificates

The abovementioned parties must furnish this information to the requesting cosmetic company within 90 days of a data request, or they will be subject to penalties of up to $10,000 per day until the request is completed.