FDA Issues Draft Guidance for MoCRA Facility Registration and Product Listing

The U.S. Food and Drug Administration (FDA) has released draft guidance, Draft Guidance for Industry: Registration and Listing of Product Facilities and Products, on the new regulatory requirements established in the Modernization of Cosmetics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

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

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.

Congress Enacts Modernization of Cosmetics Regulation

Last month FDA published a webinar titled Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions.  The purpose of the program was to provide an overview of the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”). The Act imposes new reporting and registration requirements on cosmetic manufacturers. In addition, under MOCRA, cosmetic manufacturing facilities will be required to implement Good Manufacturing Practices (GMPs).

Under MOCRA, mandatory reporting will be required for serious adverse health events caused by cosmetic products.  Responsible persons (i.e., manufacturers, packers, and distributors) will be required to report such events to FDA within 15 business days of learning about them. MOCRA defines serious adverse health events to include infections, incapacitation, significant disfigurement (e.g., serious rashes, second or third-degree burns, significant hair loss, or alternation of appearance), or any condition of severity that requires professional medical attention. Reports of adverse events must be accompanied by a copy of the label of the product at issue. Records related to adverse events must be maintained for six years. Responsible persons shall make these records to “authorized persons’ during inspections. FDA claims the new requirement aims to help FDA identify potential safety concerns with cosmetic products more quickly and take appropriate action to protect the public.

Cosmetic manufacturing facilities will now be required to register with FDA; existing facilities must register within one year of enactment of the Act, and new facilities must register within 60 days of first beginning cosmetics manufacture. Facilities must renew their registration biennially. Registration requirements include providing all brand names under which cosmetic products manufactured or processed in the facility are sold, a list of all cosmetic products manufactured at the facility, and for each product listed, product ingredients, including ingredients in fragrances and flavors. Manufacturers must also keep records documenting ‘adequate substantiation of safety’ providing competent and reliable evidence that products are safe for use. Further, the Act tasks FDA with establishing Good Manufacturing Practices within 2 years of MOCRA’s passage.

MOCRA also mandates the labeling of fragrance allergens for all cosmetics and ingredient labeling for professional use-only products used by salon workers. Additionally, FDA is to establish a standardized testing method for detecting asbestos in talc-containing products within 1 year of MOCRA’s enactment. MOCRA also requires the FDA to assess the use and safety of PFAS in cosmetics and to publish a report of the assessment to be by December 2025.

In addition, MOCRA allows FDA to request records related to a product’s safety substantiation and ingredients and request a mandatory recall of products that are misbranded and/or adulterated.

MOCRA includes a small business exemption for businesses reporting average gross annual sales for the previous three-year period is less than $1 million. The exemption is limited to small businesses that do not make cosmetics that come in contact with eye mucus membranes, are injected, intended for internal use, or alter the appearance for more than 24 hours. Qualifying businesses are exempt from the core provisions of MOCRA, including facility registration (Section 607) and good manufacturing practice or GMP (Section 606).

MOCRA preempts states from passing more stringent laws related to registration, product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation. This means that cosmetic manufacturers will be subject to a uniform set of regulations across the country.

FDA Rejects Phthalate Petition

On May 19, 2022, the US Food and Drug Administration (FDA) announced that it has denied two petitions to ban phthalates in food packaging.  In conjunction with denying the petitions, the FDA accepted a petition requesting that the Agency stops authorizing 23 phthalates for use in food containers as they are no longer used by industry.

In addition to being in food containers, phthalates are used as additives in cosmetics, detergents, and shower curtains.  Industry often uses them to soften plastics.  Although allowed in many products, the 2008 Consumer Product Safety Improvement Act bans a concentration of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP); dibutyl phthalate (DBP); or benzyl butyl phthalate (BBP) in all children’s toy and childcare articles.  Being exposed to concentrated amounts of phthalates can cause reproductive and developmental issues.

Multiple groups, including the Environmental Defense Fund and Earthjustice, have petitioned the FDA in the last decade to block the authorization of phthalates in food packaging, but the petitions have always failed, with the FDA citing a lack of information to justify blocking authorization of phthalates.

FDA’s acceptance of the petition to stop authorizing certain phthalates was due to the industry no longer using those substances. As the industry has abandoned use of those phthalates, the FDA found it appropriate to stop their authorization.  Currently, there are eight phthalates that the FDA still authorizes.  Shortly after the FDA’s announcement, they issued a request for information regarding current uses, levels, dietary exposure, and safety data for those phthalates.

Ninth Circuit rules on “all natural” food claims.

Last week, the Court of Appeals for the Ninth Circuit reversed in part and affirmed in part orders issued by a district court judge in a putative class action case involving “all natural” claims made by Dole Foods. In Brazil v. Dole, No. 14-17480 (9th Cir. Sept. 30, 2016), the plaintiff, Chad Brazil, alleged that Dole’s “All Natural Fruit” labels for packaged fruit products were deceptive under the California Unfair Competition Law (UCL), California False Advertising Law (FAL), and California Consumer Legal Remedies Law (CLRA).

The plaintiff claimed that the labels were deceptive because the products contain synthetic citric and ascorbic acid, citing evidence including informal policy issued in 1993 by the federal Food and Drug Administration (FDA), as well as more recent FDA warning letters to food sellers making similar claims (“100% Natural” or “All Natural”). The FDA’s informal policy [PDF] states that a “natural” claim on a food label is truthful and non-misleading when “nothing artificial or synthetic… has been included in, or added to, a food that would not normally be expected in the food.” In the warning letters, FDA described “natural” claims as deceptive because the food products included synthetic citrus acid, among other substances.

Upon appeal, the Ninth Circuit affirmed the lower court’s order decertifying the class because the plaintiff failed to show how to calculate the price premium with proof common to the class. The Court also affirmed the dismissal of the plaintiff’s claims for the sale of “illegal products.”

However, the Ninth Circuit reversed the district court’s granting of summary judgment on the merits of Brazil’s claims. The Court held that the evidence presented “could allow a trier of fact to conclude that Dole’s description… is misleading to a reasonable consumer.” Interestingly, the Court noted that the FDA warning letters “did not always rely on the limitation that an artificial or synthetic product would ‘not normally be expected to be in the food’ – and, in fact, asserted that foods that naturally contain citric acid (such as tomatoes) may not be labeled ‘all natural’ if synthetic citric acid is added to them.”

While unpublished, the Ninth Circuit’s opinion [PDF] may prove consequential because it suggests how the Court may interpret “natural” claims in the future. In addition, a number of other cases involving “natural” claims have been stayed while this case has been pending and the plaintiff’s bar may be emboldened to pursue further litigation.

The case has been remanded to the lower court to allow the plaintiff “injunctive relief on behalf of the class and his remaining individual claim for restitution.”

FTC enforces on “all natural” claims in personal care products.

Today, the Federal Trade Commission (FTC) announced proposed settlement agreements and consent orders with four companies for falsely marketing shampoos, sunscreen, and skincare products as “all natural” or “100% natural.” A fifth company was issued an administrative complaint for marketing “all natural sunscreen” that contains “a synthetic ingredient,” dimethicone. Other ingredients cited as “synthetic” by the FTC in the proposed consent orders include ethylhexyl glycol, phenoxyethanol, polyethylene, polyquaternium-37, polyquaternium-7, and caprylyl glycol. The complaints against all five companies allege that using such “synthetic” ingredients renders “all natural” claims false or misleading.

In these cases, the FTC’s proposed orders bar the companies from making misrepresentations in marketing a product about the following:

  • Whether the product is all natural or 100% natural;
  • The extent to which the product contains any natural or synthetic ingredient or component;
  • The ingredients or composition of the product; or
  • The environmental or health benefits of the product.

However, representations about these subjects are allowed under the proposed consent orders if the company “possesses and relies upon competent and reliable evidence” or “competent and reliable scientific evidence” that is “sufficient in quality and quantity based on standards generally accepted in the relevant fields when considered in light of the entire body of relevant and reliable evidence, to substantiate that the representation is true.”

Notably, today’s actions are not accompanied by an Enforcement Policy Statement or other guidance for companies not subject to the consent orders. FTC has raised questions in these enforcement actions such as: Which other commonly used ingredients in personal care products are “synthetic”? How does FTC determine whether a substance is “synthetic” or “natural”? Do plant-based versions of caprylyl glycol, for example, count as “synthetic”? Are processes and production considered as part of the “synthetic” vs. “natural” distinction, or just the sources or raw materials of the ingredients?

“All natural” claims are particularly difficult to substantiate because such claims are interpreted by consumers in a variety of different ways, and the various federal agencies that have jurisdiction over such claims in the United States have not provided much clarity. When issuing the revised Green Guides in 2012, for example, the FTC declined to provide guidance on “all natural” claims, citing the lack of data on how consumers interpret such claims. A December 2015 survey [PDF] by Consumer Reports found that misunderstanding about the meaning of “natural” in the food world was widespread; more than 80% of shoppers thought that in the context of processed foods, “natural” meant no pesticides were applied in production, no chemicals were used in processing, and that the food contained no Genetically Modified Organisms (GMOs) or artificial ingredients or colors. Meanwhile, the Food and Drug Administration (FDA) is still collecting public comments, through May 10, 2016, on using the term “natural” in food labeling.

FDA seeks input on “natural” food labels.

Last week, the U.S. Food and Drug Administration (FDA) announced that it is seeking comments and information on the use of the term “natural” in food labeling. The move is in response to three citizen petitions, from industry stakeholders, requesting that the agency define “natural” for food labeling and one citizen petition, from Consumers Union, asking for a prohibition on the term. The FDA also stated that it is working with the U.S. Department of Agriculture (USDA) to examine “natural” labeling for meat, poultry, and egg products.

The last time the FDA considered establishing a definition for “natural” in food labeling was 1991, when it published a proposed rule on labeling and sought comment on whether the agency “should establish a meaningful definition for ‘natural’ so that this term would have a common consumer understanding, and whether it should prohibit ‘natural’ claims entirely on the grounds that they are false or misleading.” FDA declined to define “natural” by rulemaking in 1993, but has continued to maintain its policy that labeling a food as “natural” means that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food.” Critically, the FDA’s policy does not address methods of food production (like genetic engineering or pesticide use) or processing and manufacturing (like pasteurization), nor whether “natural” describes any nutritional or health benefit.

The three petitions to the FDA regarding “natural” labeling all seek guidance on whether “natural” can apply to certain methods of food production, processing, and manufacturing. Two of the petitioners requested better harmonization with the USDA’s Food Safety Inspection Service standards. The Consumers Union petition, seeking a prohibition on “natural” food labeling, argues that “natural” is “vague and misleading,” citing a Consumer Reports National Research Center survey. That survey “suggests that nearly two-thirds of U.S. consumers are currently misled by use of the term ‘natural’ on certain food labels and nearly 90 percent expect it to ‘mean much more than it does.’”

The FDA has posed several specific questions to commenters on when “natural” labeling is misleading to consumers, including input on application to food production, processing, and manufacturing practices, as well as a request for consumer perception data on confusion with terms like “healthy” and “organic.” The agency is accepting comments through February 10, 2016, via docket number FDA-2014-N-1207.

EPA and FDA announce data sharing agreement for CBI.

Today, EPA and the Food and Drug Administration (FDA) announced a Memorandum of Understanding (MOU) to share data on pesticides and toxic substances. According to a notice published last month in the Federal Register, in response to the FDA’s spring 2014 request, EPA will grant FDA access to information collected under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including information claimed by submitters as Confidential Business Information (CBI). This data-sharing initiative “is intended to maximize the utility of data collected under those statutes, and enhance the efficiency of the participants’ regulatory processes and facilitate better risk management activities.” The MOU applies specifically to EPA’s Office of Chemical Safety and Pollution Prevention and FDA’s Foods and Veterinary Medicine Program, Center for Food Safety and Applied Nutrition, and Center for Veterinary Medicine.

FDA and EPA “have complementary roles” regulating substances incorporated into food (including animal feed), animal drugs, and cosmetics. Antimicrobial food wash products, for example, must meet different standards for safety and non-adulteration of food (FDA), and no adverse environmental effects (EPA).

The MOU covers the sharing of non-public information exempt from public disclosure, including CBI and “confidential commercial information” (CCI). Information will be shared “on a reciprocal and as-needed basis” for substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. The MOU provides that each agency will develop internal procedures and designate liaison officers for the information-sharing exchanges and to protect against unauthorized disclosure of CBI or CCI. Appendices to the MOU establish a framework process for information sharing, including specific language to be used in requesting information or responding to a request.

The MOU does not specify any limits as to programmatic uses for shared information. The disclosure of non-public information remains governed by applicable laws and regulations, and non-public information may not be disclosed further or shared with personnel at the other agency that have not been authorized to access non-public information. If EPA requests information from FDA identified as a trade secret, FDA will assess whether the information is in fact trade secret. TSCA/FIFRA-designated CBI requested by FDA will have to be returned to EPA or destroyed when no longer needed. Either agency may choose not to share requested information, or may choose to limit the scope of information provided in response to a request. The agencies may also protect information “in connection with research that has not been peer reviewed.”

Senate Bill Would Require Warning Labels for BPA on Food Containers.

On July 10, 2013, Senator Dianne Feinstein (D-Calif.) introduced legislation (S. 1124) that would require manufacturers to include warning labels on consumer food packaging containing bisphenol A (BPA). The bill, titled the “BPA in Food Packaging Right to Know Act,” would require such packaging to state “this food packaging contains BPA, an endocrine-disrupting chemical.” It would also direct the Department of Health and Human Services (HHS) to conduct a safety assessment within 180 days from passage of the bill to determine the effect of long-term low-dose exposure and high-dose exposure.  Based on the results of this assessment, HHS is to then develop a safety standard for BPA and to use that standard to evaluate possible alternatives.

BPA, which is used in epoxy resins that are used to line some metal food and drink containers and in the manufacture of some clear plastics, exhibits hormone-like properties that have raised concerns about its safety. Feinstein said in a statement that more than 200 scientific studies that have linked BPA exposure to certain types of cancer, reproductive disorders, cardiac disease, diabetes, and other problems. She said that the growing scientific evidence about BPA’s health effects makes it “essential that consumers know what chemicals are in the products they purchase.”

The American Chemistry Council (ACC), who recently obtained a court order to remove BPA from California’s Proposition 65 list of potentially dangerous chemicals, called the bill “unnecessary” because government agencies worldwide support the safety of BPA in food contact materials. The U.S. Food and Drug Administration (FDA) considers BPA to be safe at the low levels that occur in some foods, although the agency said it had concern “about the potential effects of BPA on the brain, behavior and prostate gland in fetuses, infants and young children.” The FDA is currently conducting additional research with its National Center for Toxicological Research to further determine the safety of BPA as it is used in food packaging.

The new bill is Feinstein’s latest attempt at legislation aimed at limiting the use of BPA. She had previously introduced legislation in 2009 that would have banned BPA from reusable food containers. She also tried to amend the Food Safety Modernization Act in 2010 to ban BPA from baby bottles and sippy cups. The amendment failed, although the FDA later used its authority to implement the same ban in 2012. On July 12, 2013, in response to a petition introduced by Senator Edward Markey (D-Mass.), the FDA also abandoned the use of BPA in packaging for infant formula. In both cases, the FDA took action after determining that manufacturers in the industry had already phased out BPA for those uses.

Currently, thirteen states currently have pending legislation that would ban BPA from children’s products and food containers. Two other states, South Dakota and Connecticut, have legislation similar to the Feinstein bill, which would require BPA warning labels on food and drink packaging.