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FDA Regulation of Drugs, Dietary Supplements & Cosmetics: A Primer for Wellness Providers

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When it comes to substances that people ingest, get injected or apply on their body, the key question wellness providers must ask is whether that substance qualifies as a “drug” or something else.  If it is something else, such as a nutritional supplement or cosmetic, the burden of FDA regulation is much lighter.

To determine whether a substance qualifies as a drug, the wellness provider should ask the following questions:

  1. Is my product intended to diagnose, cure, mitigate, treat or prevent disease?
  2. Is my product something other than food and intended to affect the structure or any function of the body?[1]

“Therefore, almost any ingested or topical or injectable product that, through its label or labeling (including internet websites, promotional pamphlets, and other marketing material), is claimed to be beneficial for such uses will be regulated by FDA as a drug.”[2] Drugs can not only include medications, whether over the counter or prescription, but can also include stem cell therapies, for example.[3]

Note that in question number two, above, there is a carve out for “food.” Humans ingest food products that will affect the structure and function of the body. Food products, including nutritional supplements, are regulated separately from drugs, as long as those products follow certain guidelines, discussed later.

So, if a wellness professional works with products to help clients cure, treat or prevent disease, that professional should work with legal counsel to ensure that their product complies with FDA requirements for drugs, which, as outlined below, are quite rigorous. Alternatively, the wellness professional may be able to fit their product into a less regulated category, such as nutritional supplements or cosmetics, by rethinking the intended use of the product.

Brief Overview of FDA Drug Regulation

If a wellness provider’s product qualifies as a “drug,” it faces a very rigorous evaluation and regulatory process. Drugs must generally either:

  1. Receive premarket approval by the FDA through the New Drug Application (NDA) process; or
  2. Conform to a “monograph” for a particular drug category, as established by the FDA’s Over-the-Counter (OTC) Drug review.[4]

NDA Process

The NDA process is a long process with many phases. Here is a brief description of the NDA process:

  1. Animal Testing: When a drug sponsor develops a new drug compound, it first tests the drug on animals for toxicity.
  2. IND Application: Assuming no significant toxicity on animals, the sponsor then submits an Investigational New Drug (IND) application to the FDA. The application describes the drug’s composition and manufacturing, and develops a plan for testing the drug on humans.
  3. Phase I testing: the drug sponsor tests the drug on 20-80 healthy volunteers. This phase emphasizes safety and determines what the drug’s most frequent side effects are and how often the drug is metabolized and excreted.
  4. Phase II testing: the drug sponsor tests the drug on hundreds of individuals, typically in a controlled trial (where some individuals receive the drug and others receive a placebo). This phase emphasizes effectiveness and the goal is to obtain data on whether the drug works in people who hae certain diseases or conditions. At the end of Phase II, the FDA and the drug sponsor discuss how large-scale studies in Phase III will be conducted.
  5. Phase III: The drug sponsor tests the drug on thousands of individuals to gather more inofrmaiton about safety and effectiviness.  The sponsor studies different populations and different dosages of the drug, and uses the drug in combination with other drugs.
  6. FDA Review Meeting. The FDA meets with the drug sponsor prior to the NDA application.
  7. NDA Application: The drug sponsor submits an NDA, which formally asks the FDA to approve the drug for marketing in the United States. The application includes all animal and human data and analyses, as well as information about how the drug behaves in the body and how it is manufactured.
  8. FDA Review of the NDA Application. The FDA has 60 days to review the file to determine if it is ready for review. If it is ready for review, the FDA Review team begins evaluating the sponsor’s research on the drug’s safety and effectiveness. If it’s not ready for review, because the application is incomplete, for example, the FDA will not move the file forward in the process. The FDA’s Center for Drug Evaluation and Research (CDER) can take ten months to review a file after the application is received.[5]
  9. Drug Labeling Review. The FDA also reviews the drug’s labeling and assures appropriate information is communicated to healthcare professionals and consmers.
  10. Facility Inspection. The FDA inspects the facilities where the drug will be manufactured .
  11. Phase IV: Once the FDA approves a drug and the drug is out on the market, the FDA continues to monitor the drug for safety issues. The drug sponsor must submit periodic safety updates to the FDA.[6]

As one can see from the outlined drug approval process, the FDA scrutinizes everything about the new drug, from clinical trial design, severity of the side effects, to the conditions under which the drug is manufactured. The clinical trials are probably the longest portion of the NDA approval process, taking years to complete.[7]

Monograph Process

If a wellness provider creates a nonprescription drug product for sale, the provider may be able to use the Over-the-Counter (OTC) Drug Monograph rather than the NDA process described above.  The OTC Monograph is a “rule book” for each therapeutic category of drug, establishing conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without an NDA and FDA pre-market approval.[8]  Some examples of nonprescripton drug categories that are part of the OTC Monograph include:

  • Acne medications
  • Treatments for dandruff, seborrheic dermatitis and psoriasis
  • [9]

The OTC Monographs are published in the Federal Register.[10]If a drug category does not exist already, a wellness provider may submit an OTC monograph order request with the FDA to add, change or remove a monograph.[11]The advantage of being able to use the OTC Monograph process over the NDA process is that the Monograph process is likely less time consuming and less expensive to get one’s product to market.

Other Drug Requirements by the FDA

In addition to the approval process, those involved with making or distributing drugs must consider the following:

  • Follow Good Manufacturing Practice (GMP) Guidelines
  • Register the drug firm and list drug products with FDA
  • Labeling requirements applicable to drugs.[12]

The bottom line is that FDA’s regulation of drugs, with either the NDA process or the OTC Monograph process, is much more involved compared to the regulation of other substances, such as nutritional supplements or cosmetics.  However, if a wellness provider creates and markets a product that has drug ingredients or intended effects of drugs, that product may qualify as a drug, even though the wellness provider believes their product to be a nutritional supplement or cosmetic.

For example, if a wellness provider sells cranberry tablets to “prevent urinary tract infections,” the FDA would consider the use of those tablets to be a drug, not a dietary supplement. In this case, the wellness provider could likely avoid drug regulation by labeling and marketing the product as “for use to maitian the health of the urinary tract.”[13]

Another example is when a wellness provider intends a moisturizer’s use help relieve pain or prevent psoriasis.  In that case, the wellness provider could avoid the more rigorous drug regulation by intending the use to be solely for “beautification or appearance-altering purposes,” which would qualify the moisturizer as a cosmetic rather than a drug.[14]

Brief Overview of Non-Drug FDA Regulation

Two types of non-drugs often used by the wellness industry includes nutritional or “dietary” supplements and cosmetics. FDA regulation of these two substances is much less onerous than drug regulation. Unlike drugs, the FDA does not require premarket approval before selling most nutritional supplements or cosmetics.[15] (But see footnote on “New Dietary Ingredients.”) Therefore, whether a nutritional supplement or cosmetic is safe and effective for consumers is the responsibility of the manufacturer of those products.

To fall within these two non-drug categories, wellness providers must take care to stay within the bounds of what defines a nutritional supplement or cosmetic. This can be difficult. By their very nature, wellness providers want to improve health and wellness of individuals. However, if wellness providers try to address specific diseases or conditions with products they create and sell, the FDA may conclude that those products function as a drug, and not just as a nutritional supplement or cosmetic. The remainder of this chapter will discuss FDA regulatory considerations of those types of products.

Regulation of Nutritional or Dietary Supplements

FDA defines “nutritional” or “dietary” supplements as “products taken by mouth that contain a ‘dietary ingredient.’ Dietary ingredients include:

  • Vitamin and mineral products
  • Botanical or herbal products, which may include plant materials, algae, macroscopic fungi, or a combination of those
  • Amino acid products
  • Enzyme supplements[16]

Wellness providers who develop their own dietary supplements or who market such supplement as part of their wellness practice must be careful not to cause the FDA to treat the supplement as a drug. As noted above, whether a product qualifies as a drug depends on its intended use. The FDA determines intended use by reviewing:

  • Product labels
  • Advertising matter
  • Oral or written statements by manufacturers, sponsors or their representatives.[17]

Therefore, to avoid regulation as a drug, it is imperative that the wellness provider appropriately and accurately labels and markets the dietary supplement. If the wellness provider fails to do so, FDA may deem the product “misbranded” and can take enforcement action against such providers.[18]  Enforcement actions can range from  issuing warning letters to criminal prosecution.[19]

FDA considers a dietary supplement “misbranded” if the product “labeling” is false or misleading in any way, or makes inappropriate claims.[20]  “Labeling” can include not only the label on the box, but also any written, printed or graphic material accompanying the product (including the website). Dietary supplements also cannot be “adulterated” (which includes, among other things, containing poisonous or insanitary or unsafe ingredients, or substituting ingredients for those listed on the label).[21]

Inappropriate claims include disease (or therapeutic) claims—those that claim a product will diagnose, cure, mitigate, treat, or prevent disease.[22]  If a wellness provider makes a disease claim, then the FDA regulates the product  as a drug, which requires prior proof of safety and efficacy before selling the product in interstate commerce.

“Disease” is defined as “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.”[23]

The most common permissible claims for dietary supplements are structure/function claims.  These describe the role of a substance intended to maintain the structure or function of the body, or general well-being from consumption of a nutrient or dietary ingredient. Recall that drug claims typically include not only disease claims, but also claims that a substance affects the structure or function of a human body.[24]  However, Congress allowed dietary supplement manufacturers to make “structure/function” claims without falling into drug classification when it passed the Dietary Supplement Health and Education Act of 1994 (DSHEA). Specifically, DSHEA allows dietary supplement labeling to bear a statement that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.[25]

For example: the claim, “reduces obesity” would likely be deemed a disease claim, whereas “supports the immune system” is a structure/function claim.

FDA looks at the overall meaning of the claim, not at whether certain terms such as, “supports,” are used.  For example, when FDA published the structure/function final rule, it explained that “maintains healthy lungs in smokers” would be a disease claim, because it implies prevention of tobacco-related lung cancer and chronic lung disease.[26]

FDA lists different ways that a product can make a prohibited disease claim.[27]  These include claims that:

  • The product has effect on a disease or a symptom of a disease; is a substitute for a drug;
  • The product has a role in the body’s response to a disease; or
  • Consumers would understand to refer to a disease.  For example, “controls blood sugar in persons with insufficient insulin” would be considered an impermissible disease claim as it could easily be understood to refer to treatment of diabetes.

 

Substantiation

Another area of regulation of dietary supplements involves substantiation of claims. Both FDA and the Federal Trade Commission (FTC) require that all statements regarding a product need to be truthful and non-misleading.  Among other things, this means that the advertiser must have adequate substantiation or underlying evidence for the intended use.  Normally, this means the claim must be supported by “competent and reliable scientific evidence.”

FDA and FTC define “competent and reliable scientific evidence” as: “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”[28]

In determining whether this standard has been met, FDA considers four issues:[29]

  1. The meaning of the claim(s) being made.
  2. The relationship of the evidence to the claim.
  3. The quality of the evidence.
  4. The totality of the evidence.

Unsubstantiated or inadequately substantiated claims are not only problematic from the FDA perspective; they can also generate lawsuits from private plaintiffs, including consumers and competitors.  Law firms representing plaintiffs are actively looking for new entrants to the dietary supplement market and scrutinizing their websites and marketing materials for potential fodder for large, class-action lawsuits.

Disclaimer, Notification, & Registration with FDA

Other requirements that wellness providers who sell nutritional supplements must follow include disclaimer, notification and registration requirements.

If the wellness provider makes a structure or function claim or a claim that the nutritional supplement helps with a nutrient deficiency, then the provider must include the disclaimer about that claim:

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.[35]

The statement must be “prominently displayed and in boldface type.”[36]  The regulation is very specific about the text, placement, and typesize of the disclaimer.[37]

Anytime the wellness provider uses the disclaimer, they must prepare a notification to FDA no later than 30 days after the first marketing of the product that the manufacturer is making the structure/function statement in accordance with the applicable regulation.[38] The notification shall include the following:

  • The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement;
  • The text of the statement that is being made;
  • The name of the dietary ingredient or supplement that is the subject of the statement, if not provided in the text of the statement; and
  • The name of the dietary supplement (including brand name), if not already provided in response to paragraph (a)(2)(iii) on whose label, or in whose labeling, the statement appears.[39]

Registration and GMP of Manufacturer

Manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling supplements. “In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices (GMP) for those who manufacture, package or hold dietary supplement products. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.”[40]

Manufacturers of dietary supplements must also comply with Good Manufacturing Processes to ensure that the products are safe and unadulterated.[41] Some examples of these processes include implementing a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.[42] Other requirements include sanitization, water quality, water availability, proper drainage, etc.[43]

Cosmetics

The FDA defines a cosmetic as a “product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance.”[44] The FDA defines “soap” as a product in which the non-volatile portion consists principally of an alkali salt of fatty acids, i.e., the traditional composition of soap; the product is labeled as soap; and the label statements refer only to cleansing.[45] If cosmetic claims, e.g., moisturizing, deodorizing, skin softening etc., are made on a label, the product is a cosmetic.[46]

Like dietary supplements, cosmetic products are also subject to less FDA regulation compared to drugs. Cosmetics require no premarket approval by the FDA.[47] As a result, like dietary supplements, cosmetic manufacturers and distributors have a responsibility to ensure the safety and effectiveness of their products. The FDA is likely to take action against a cosmetics manufacturer or distributor if the product is unsafe or misleading. Thus, cosmetic manufacturers and distributors must avoid misbranding and adulteration, just as with nutritional supplements.[48]

The FDA will consider a cosmetic to misbranded if:

  • labeling is false or misleading
  • label does not state
    • the name and address of the manufacturer, packer, or distributor
    • the net quantity of contents
  • the required information is not stated prominently, with conspicuousness and in terms that it is read and understood by consumers under customary conditions of purchase and use
  • the container or its fill is misleading.[49]

A cosmetic is adulterated if:

  • The product is injurious to consumers under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance;
  • The product contains filth;
  • The product contains a non-permitted, or in some instances non-certified, color additive; or
  • The product is manufactured or held under insanitary conditions whereby it may have become injurious to users or contaminated with filth.[50]

As with nutritional supplements, the intended use of the cosmetic will determine whether the product truly functions as a cosmetic, or functions as a drug (in addition to functioning as a cosmetic). Thus, the claims a manufacturer or distributor makes about a cosmetic product, in its labeling and advertising, will help determine the product’s intended use. Courts will also rely on a consumer’s perception of the meaning of a label statement when determining a product’s intended use.[51]Examples of possible drug claims for cosmetic products are that the product will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin in the skin, or regenerate cells.

Wellness providers should also be mindful of good manufacturing practices for cosmetics. Although cosmetic manufacturers are not required to follow these practices, good manufacturing practices can reduce the risk of misbranding or adulteration of cosmetic products. The FDA has created a guidance document for the cosmetics industry to adopt good manufacturing practices that address:

  • Documentation
  • Records
  • Buildings and Facilities
  • Equipment
  • Personnel
  • Raw Materials
    • Water
    • Color Additives
    • Prohibited and Restricted Cosmetic Ingredients
  • Production
  • Laboratory Controls
  • Internal Audit
  • Complaints, Adverse Events, and Recalls[52]

Note that unlike nutritional supplements, which may disclose “structure/function” claims, cosmetic manufacturers or distributors may not make such claims without triggering drug regulation.[53]

Conclusion

Wellness providers who wish to create or sell products that could be subject to FDA regulation should work with their legal counsel to find the best and most appropriate product category, such as drug, nutritional supplement or cosmetic. Once the most appropriate category or categories is determined, the wellness provider should follow FDA and FTC guidelines to ensure its products are compliant, as well as safe and effective for consumer use.

Please contact the Center for Health and Wellness Law, LLC for help with ensuring your wellness product meets FDA and FTC requirements.

 

[1] FDA Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration, at 7-8 (Dec. 2006).

[2] FDA Fact Sheet: Human Drugs (Nov. 17, 2020), available at https://www.fda.gov/industry/regulated-products/human-drugs (last visited Jan. 1, 2021).

[3] FDA Letter to Dale Carrison of Dynamic Stem Cell Therapy (April 1, 2020), available at https://www.fda.gov/media/136668/download (last visited Jan. 2, 2021) (concluding that the company’s adipose derive dcellular product and human umbilical cord derived cellular product would be regulated as drugs and biological products as defined in Sections 201(g) of the FDCA and 351Ii) of the PHS Act.

[4] FDA Fact Sheet:  Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), available at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap (last visited Jan. 1, 2021).

[5] FDA Fact Sheet:  The FDA’s Drug Review Process: Ensuring Drugs are Safe and Effective (Nov. 24, 2017), available at https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective (last visited Jan. 1, 2021).

[6] Id; see also FDA Drug Approval Process Infographic Fact Sheet (Feb. 26, 2016), available at https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fda-drug-approval-process-infographic-horizontal (last visited Jan. 1, 2021);.

[7] FDA Fact Sheet:  The FDA’s Drug Review Process: Ensuring Drugs are Safe and Effective (Nov. 24, 2017), available at https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective (last visited Jan. 1, 2021).

[8] FDA Over-the-Counter (OTC) Drug Monograph Process Fact Sheet (Sept. 3, 2020), available at https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process (last visited Jan. 2, 2021).

[9] FDA Fact Sheet:  Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), available at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap (last visited Jan. 1, 2021).

[10] Id.

[11] FDA Over-the-Counter (OTC) Drug Monograph Process Fact Sheet (Sept. 3, 2020), available at https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process (last visited Jan. 2, 2021).

[12] FDA Fact Sheet:  Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), available at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap (last visited Jan. 1, 2021).

[13] FDA Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration, at 12 (Dec. 2006).

[14] Id.

[15] Id; see also FDA Fact Sheet: Questions and Answers on Dietary Supplements (July 22, 2019), available at https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements#:~:text=Unlike%20drug%20products%20that%20must,before%20they%20reach%20the%20consumer (last visited Jan. 3, 2021).  However, if the wellness provider develops a nutritional supplement containing a “new dietary ingredient,” the provider must provide the FDA premarket notification. “New dietary ingredient” means a dietary ingredient that was not marketed in the U.S. in a dietary supplement before October 15, 1994. FDA Fact Sheet:  New Dietary Ingredients in Dietary Supplements – Background for Industry (Oct. 26, 2020), available at https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/new-dietary-ingredients-dietary-supplements-background-industry (last visited Jan. 3, 2021).  The manufacturer and distributor of the new dietary ingredient must demonstrate to the FDA why the ingredient is reasonably expected to be safe for use in the dietary supplement, unless it has b een recognized as a food substance and is present in the food supply. FDA Fact Sheet: Questions and Answers on Dietary Supplements (July 22, 2019),

[16] FDA Fact Sheet:  FDA 101:  Dietary Supplements (July 15, 2015), available at https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements (last visited Jan. 2, 2021).

[17] FDA Presentation: OTC vs. Prescription, Slide #3, available at https://www.accessdata.fda.gov/scripts/cder/training/otc/topic2/topic2/da_01_02_0045.htm (last visited Jan. 2, 2021).

[18] See e.g., FDA Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight (Feb. 11, 2019), available at https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-new-efforts-strengthen-regulation-dietary (last visited Jan. 2, 2021).

[19] FDA Fact Sheet: Compliance and Enforcement (Sept. 10, 2020), available at https://www.fda.gov/food/compliance-enforcement-food (last visited Jan. 2, 2021).

[20] 21 USC § 343.

[21] 21 USC § 342.

[22] 63 Fed. Reg. 23624 (April 29, 1998).

[23] 21 C.F.R. §101.93(g).

[24] Infra, n. 95.

[25] 21 CFR § 101.93(f) and (g).

[26] 65 Fed. Reg. 1000, 1018 (Jan. 6, 2000).

[27] 21 CFR §101.93(g).

[28] FDA, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (Sept. 9, 2018), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food#:~:text=The%20FTC%20standard%20of%20competent,qualified%20to%20do%20so%2C%20using (last visited Jan. 3, 2021).

[29] Id.

[30] Id.

[31] Id.

[32] Id.

[33] Id.

[34] Id.

[35] 21 CFR § 101.93

[36] Id.

[37] Id.

[38] 21 CFR § 101.93(a).

[39] Id.

[40] FDA Fact Sheet: Questions and Answers on Dietary Supplements (July 22, 2019).

[41] 21 CFR Part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.)

[42] 21 CFR 111.55.

[43] 21 CFR Part 111.

[44] FDCA § 201(i).

[45] 21 CFR § 701.20.

[46] FDA Cosmetics Labeling Guide Fact Sheet (Aug. 24, 2020), available at https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide (last visited Jan. 3, 2021).

[47] FDA Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration, at 12 (Dec. 2006).

 

[48] FDCA § 301.

[49] FDCA § 602.

[50] 21 CFR § 361.

[51] FDA Cosmetics Labeling Guide Fact Sheet (Aug. 24, 2020).

[52] FDA Draft Guidance for Industry:  Cosmetic Good Manufacturing Practices (June 2013), available at https://www.fda.gov/media/86366/download (last visited Jan. 3, 2021).

[53] FDA Cosmetics Labeling Guide Fact Sheet (Aug. 24, 2020).