FDA to be granted greater authority over cosmetic regulations in 2024.
By Andrea Niermeier, Contributing Writer, October 1, 2023
Social media has opened the door for cosmetic brands to use new and innovative ways to connect with consumers. Instead of walking the aisles of their favorite store, more people are discovering their makeup, skin care, and hair care products online through platforms such as Tik Tok, Instagram, and YouTube as social media influencers bring consumer bases closer to the brands that sponsor them. With the beauty industry generating over $100 billion in revenue worldwide, according to Statista, the question remains: Who is responsible for ensuring the safety and effectiveness of these cosmetic products?
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Key takeaways from this article:
MoCRA introduced what the FDA describes as “the most significant expansion of the FDA’s authority to regulate cosmetics since the FD&C Act was passed in 1938.”
MoCRA amends the FD&C Act to grant the FDA access to certain records and information, including adverse event report information, as part of a facility inspection.
MoCRA allows the FDA the authority to issue mandatory recalls under certain conditions.
Industry will be required to report serious adverse events associated with the use of cosmetic products in the U.S. to the FDA within 15 business days of receiving the report, along with a copy of the label on or within the product’s retail packaging.
Industry will soon have to file their facility as well as their products with the FDA.
The FDA is required to establish regulations for Good Manufacturing Practices (GMPs) to help industry businesses identify and mitigate the risks associated with production that can impact product safety and quality.
The Food, Drug, and Cosmetic (FD&C) Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.” According to the FDA, on average people use six to 12 cosmetics daily, including makeup, nail polishes, grooming products, perfumes, face and body cleansers, hair care products, moisturizers, deodorants, as well as any material intended for use as a component of a cosmetic product. Products such as botulinum toxin injectables that are used to treat facial wrinkles by keeping muscles from tightening are not considered cosmetics by law as they are “intended to affect the structure or any function of the body,” a key part of the FD&C Act’s definition of a drug.
The marketing of adulterated or misbranded cosmetic products has long been prohibited in the United States. Adulterated products include those that contain contaminated cosmetic products, including those made in unsanitary conditions, those that may appear sanitary but are made in unsanitary conditions, as well as those with poisonous or deleterious substances that may pose harm to a person under normal conditions of use. (Read the FDA’s full definition of adulterated cosmetic products). Misbranded products include improperly labeled or deceptively packaged products. The two most important pieces of legislation regulating cosmetics marketed in the United States are the FD&C Act and the Fair Packaging and Labeling Act (FPLA). While these laws allow the FDA to regulate cosmetics in the United States, they do not grant the FDA authority to approve products or ingredients, other than color additives, before a product is marketed to the public. According to the FDA, “all companies and individuals who manufacture or market cosmetics are responsible for ensuring that a marketed cosmetic is safe when consumers use it according to the directions in the labeling or in the customary or expected way.”
“There’s an effort right now for consistency in the market, consistency in the products sold, and consistency in what is safe and approved for people to use in cosmetics.”
Just last year, however, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) introduced what the FDA describes as “the most significant expansion of the FDA’s authority to regulate cosmetics since the FD&C Act was passed in 1938.” Stephanie Croney, JD, assistant director of regulatory policy at the American Academy of Dermatology Association (AADA) noted, “There’s an effort right now for consistency in the market, consistency in the products sold, and consistency in what is safe and approved for people to use in cosmetics.” The first of these new regulations to help achieve this uniformity are scheduled to take effect by the end of the year.
Increased access during inspections
Under current law, the FDA has legal authority to inspect cosmetic manufacturing establishments. According to the FDA, the decision to inspect a facility may be based on many factors including type of product, significance of consumer or trade complaints received, a company’s compliance history, FDA surveillance and compliance initiatives, and agency resources. The operational status of a firm, findings from previous inspections, as well as regulatory follow-up strategy may also be considered.
During an inspection, an FDA investigator may look for prohibited or improper use of ingredients, noncompliance with requirements related to color additives, microbial contamination, and deficiencies in labeling and packaging. They may collect samples of cosmetic ingredients or finished products as part of routine surveillance or import inspections if adulteration or misbranding is suspected. They may also take samples as part of a consumer complaint or adverse reaction. Not only the product but also the facility can be assessed, including the adequacy of the building and equipment as well as warehousing and storage of raw materials. Furthermore, production procedures, personnel training, and laboratory and other quality controls can be examined. The FDA determines from the information gathered during the inspection and the results of the sample analysis whether a product is adulterated or misbranded.
MoCRA amends the FD&C Act to grant the FDA access to certain records and information, including adverse event reporting information, as part of a facility inspection. If the FDA has reasonable belief that a cosmetic or ingredient in a cosmetic is adulterated and the use or exposure to the product presents a serious health consequence to humans, the agency can access and copy certain safety records related to the cosmetic product.
What happens with imported cosmetics?
Imported products can potentially be unlabeled, misbranded, or contain dangerous ingredients such as mercury or bleach. FDA investigators work closely with U.S. Customs and Border Protection (CBP) to monitor imports, and these products are subject to examination upon entry into the United States.
Imported cosmetics must comply with the same laws and regulations as domestic products, meaning they do not require premarket approval by the FDA, with the exception of color additives. However, they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled.
Foreign cosmetics that appear to be adulterated or misbranded may be refused entry into the United States. Some common reasons cosmetic products are refused entry include unsafe ingredients or contaminants, color additive violations, prohibited and restricted ingredients, microbial contamination, deficiencies in labeling and packaging, and claims that cause a product marketed as a cosmetic to be subject to regulation as a drug under U.S. law. These denied products must be brought into compliance, destroyed, or re-exported.
Not all cosmetics are inspected or sampled upon entry. For efficiency, the FDA issues Import Alerts to advise inspectors of trends in violations. However, examination of imported cosmetics is not limited to the types of products specified in Import Alerts, and those not examined are still subject to all the legal requirements.
Added recall authority
In addition to increased record accessibility, MoCRA allows the FDA the authority to issue mandatory recalls under certain conditions. The agency stated that if there is “a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, the FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.”
Traditionally, a recall has been the firm’s voluntary removal or correction of a marketed product that is hazardous, grossly deceptive, or defective. Whatever the reason, the adulterated or misbranded product is a violation of the law, and the FDA can initiate legal action if not corrected. The FDA pointed out that it “makes every effort to work with the manufacturer or marketer to voluntarily remove adulterated or misbranded products from the marketplace before taking any regulatory action.” Such governing action may include using the Department of Justice and federal court system to remove the violative product or seek a restraining order to prevent further shipment of the cosmetic. Furthermore, the government can seize cosmetics not in compliance with the law as well as initiate criminal action against a person violating the law.
Even when the FDA does not issue the recall, it plays an active role in the process by monitoring the recall progress, evaluating the health hazard of the product, assigning a degree of hazard, and issuing public notification if the firm is unwilling or delaying notification. The FDA also publishes general information about recalls through a weekly publication — the FDA Enforcement Report — which provides information on recalls that have been assigned a classification.
If the FDA requests a recall, it develops a recommended strategy that indicates the agency’s expectations, and if the firm develops the strategy, the FDA reviews it and comments on it. Also, during a recall, the agency makes sure that the product is destroyed or suitably reconditioned. A recall is terminated when the FDA determines that all reasonable efforts to remove or correct the problem have been made as detailed by the recall strategy and called for based on the product’s degree of hazard.
Additional industry requirements
While MoCRA grants the FDA additional cosmetic regulatory authority, it also establishes new requirements for the cosmetic industry. Specifically, the “responsible person” (meaning the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label) must meet new demands regarding adverse event reporting. They will soon be required to report serious adverse events associated with the use of cosmetic products in the U.S. to the FDA within 15 business days of receiving the report, along with a copy of the label on or within the product’s retail packaging. Serious adverse events include death or life-threatening experience, hospitalization, significant disability or incapacity, congenital anomaly or birth defect, infection, significant or persistent disfigurement, or medical or surgical intervention to prevent one of these outcomes.
Moreover, responsible persons must report information such as new medical information within one year of the initial report, and 15 business days after receiving such information. According to Amy Spizuoco, DO, FAOCD, FAAD, the new regulations have generated buzz in the dermatology world. “We are really excited about the changes. If there is anything out there that patients are using that can affect their skin, there should be more rules and regulations about it. The adverse reporting is going to be key.” The FDA is currently developing a process for submitting mandatory adverse event reports for cosmetics. (See FDA Adverse Event Reporting System [FAERS] Electronic Submissions for additional details). Croney echoed Dr. Spizuoco’s thoughts about adverse reporting, adding that, “a better reporting process will help the FDA make sure they get real-time updates about potentially harmful products.”
MoCRA’s new facility registration and product listing requirements also have the FDA developing a new system to handle the large number of submissions that will result from the change. Many manufacturers will soon have to file both their facility as well as their products with the FDA. Previously, registration was voluntary and utilized the Voluntary Cosmetic Registration Program (VCRP), which was discontinued in March of this year. The VCRP helped the FDA acquire cosmetic safety information; however, because the VCRP system was not mandatory, it did not give the agency a complete picture of products marketed in the U.S. Under the new regulations, responsible persons (manufacturer, packer, or distributor of a cosmetic product) will have to review their registration every two years and product listings annually. Croney sees the benefit of more accountability for cosmetic manufacturers. “It’s important for companies to keep track of where we are seeing issues. They have a better view of whether it is more of a supply chain issue or product issue. While the product manufactured at the facility may be fine, the transfer or product storage may cause an issue.”
In addition, the new legislation also requires responsible persons to maintain records supporting adequate safety substantiation that could be accessed by the FDA. The law does not require specific tests for any particular product or ingredient, and manufacturers can use relevant safety data that is already available. Even so, studies, research, and analysis should be derived from scientifically robust methods to support that a cosmetic product is safe.
Future guidance from the FDA
Just as MoCRA requires new efforts from cosmetic manufacturers, it also places new responsibility on the FDA to develop regulations to guide the cosmetic industry. For example, the new legislation tasks the FDA to establish regulations for Good Manufacturing Practices (GMPs) to help industry businesses identify and mitigate the risks associated with production that can impact product safety and quality. In addition, the FDA will be creating standardized testing methods for detecting and identifying asbestos in cosmetic products containing talc.
While responsible persons will be accountable for complying with a new labeling provision necessitating a domestic address, phone number, as well as electronic contact information on products, the FDA will use international, state, and local allergen requirements to establish fragrance labeling regulation that requires fragrance allergens to be disclosed on cosmetic labels. These new labeling laws are something dermatologists like Dr. Spizuoco are ready to see. “We are looking forward to it because a lot of consumers are misguided. They spend a lot of money on products to try, but in some cases, their skin becomes irritated. More regulation is definitely warranted.”
Role of physician in cosmetic safety and regulation
While cosmetic manufacturers and the FDA play key roles in consumer safety, dermatologists can also help protect consumers. Dr. Spizuoco commented, “I do think physicians should educate patients that their cosmetic products are not FDA approved as well as recommend asking a board-certified dermatologist before using a new product on their skin, hair, or nails.”
Taking the time to ask questions about what products the patient is using can help them use safe and effective products to achieve desired results. Dr. Spizuoco noted, “I spend a lot of time directing my patients to safe products. There’s such a push for preventative anti-aging right now. I take the time to go over the ingredients on the labels they take a picture of or bring in with them to make sure they are safe and functional for their skin type.” She cautions her patients to pay attention to the inactive ingredients in a product as much as the active ones as these can also potentially cause adverse reactions. In addition, she advises that while some websites reviewing cosmetic products for safety can be somewhat helpful, they should not replace a conversation with a board-certified dermatologist who can provide an individualized skin evaluation and product recommendations.
Dermatologists can not only be an important resource for consumer education. They can also use testing to determine what ingredients may cause a patient an adverse event. Dr. Spizuoco recommends that a consumer seek out a board-certified dermatologist for such analysis. “In our office, we do patch testing for agents or allergens that the skin can be sensitive to — like fragrance or preservatives put into face lotions, washes, and cosmetics. This testing helps us develop a list of ingredients that they have potential sensitization to, so that when they purchase their cosmetics, they can avoid that chemical.”
“I do think physicians should educate patients that their cosmetic products are not FDA approved as well as recommend asking a board-certified dermatologist before using a new product on their skin, hair, or nails.”
In the case of an adverse event, dermatologists can also help determine whether a particular product is the cause. Dr. Spizuoco first recommends that a patient stop using the suspected product for a week or two to determine if that product is causing the symptoms. While patients may believe they are buying a product they have used for years, Dr. Spizuoco cautions, “Sometimes I see companies change their formulation throughout the years but give no warning to the consumer, who may have an unwanted reaction.” In these cases, she will often take some of the patient’s product, turn it into a well, and make it into a patch test to confirm that the product is causing the reaction.
Encouraging patients to report adverse events to the company is another way dermatologists can help keep consumers safe. Patients should use the contact information found on the product label that will now be more robust after MoCRA. In addition, consumers, health professionals, attorneys, and members of the cosmetic industry can report a complaint or adverse event in one of three ways: call an FDA consumer complaint coordinator, complete an electronic Voluntary MedWatch form online, or fill out a paper Voluntary MedWatch form to mail to the FDA.
As technology opens the door for a more global cosmetic market, non-skin care experts may promote products that consumers can purchase by simply swiping up and clicking a link. Dr. Spizuoco acknowledges, “While there used to be just a few big names in skin care, now there are many brands out there from around the world. It’s hard to know exactly what is being put into these products that people are putting on their skin, hair, and nails.” New regulations introduced in MoCRA, along with existing laws in the FD&C Act and the FLPA, will help dermatologists, the FDA, and cosmetic companies continue to steer safe and effective products into the hands of U.S. consumers.