The FDA and the Skincare Industry

CONTRIBUTORS: Janis Leahy & Carrie Holden

First things first: this is not an FDA hate post. Too often on the “clean” side of the beauty industry, I hear a squawking racket of anti-science diatribes and conspiracies about the bureau that has jurisdiction over our safety. The FDA is an important agency that does so much to keep us safe. That’s not to say that I don’t have criticism for how we handle a lot of consumer safety in the US, but it’s my opinion that we should save much of that criticism for the institution that bestows power to every agency in our government: Congress. Congress passes laws, the FDA simply enforces them. 

When it comes to personal care and beauty products, the law has left the FDA relatively toothless. As I’ve written in a previous post, it’s been decades since any significant laws have been passed that would update regulation for the beauty industry. Additionally, both Congress and the FDA have an infestation of lobbyists creating muddied waters and preferential treatment – there are 405 lobbyists for the FDA alone [12]. While some of those lobbyists include noble causes, you still find companies like Phillip Morris outpacing them exponentially in lobbyist spending ($6.3M lobbying expenditure in 2021 compared to $30K from causes like the Society for Maternal-Fetal Medicine). To make matters worse, it’s not unheard of for a former FDA Commissioner, Congressperson, or Senator to join the board of directors for a pharmaceutical company they once oversaw in their government role.

So What is Regulated by the FDA?

Let’s take a look at what the FDA does regulate in terms of cosmetics and personal care products so you can make more informed decisions as a consumer.

1- The Legal Definition of “Cosmetics”

• “The FDA determines what falls under the “cosmetic” category. The 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” [1].

2- The marketing of “adulterated” products [1],[2],[3]

• If a cosmetic product does not meet the following standards, it is considered adulterated by the FDA: the product and packaging must be manufactured in a sanitary environment, there are no rotten or poisonous materials in the product itself, nor the packaging, and it cannot contain color additives known to be toxic (with some exceptions for hair dyes).

3-  The marketing of “misbranded” cosmetics [1],[2],[3],[7]

• According to the FDA a misbranded cosmetic product is defined as having false or misleading labeling, a label that lacks required information, the required information is not prominent & conspicuous, and/or the packaging does not meet safety standards.

4- The prohibition/restriction of certain ingredients

• The US government actually only prohibits an incredibly short list of 11 ingredients in comparison to regulation in the European Union, which bans/restricts 1300 ingredients [8], [10].
• In regards to sunscreen, if there is an SPF claim on a product, it falls under the definition of being a drug and is subject to more rigorous FDA drug testing and recall protocol [10].

What we think the FDA regulates, but doesn’t:

1 – Labels such as natural, clean, and organic 

• Natural – No government body in the United States regulates this term, so it is essentially meaningless. Be wary of any brand that labels their products as such as this is a known marketing tool that is often exploited given its lack of regulation.
• Clean – Much like “natural” has no regulated definition. If a company or brand claims to be “clean,” they should provide a definition of what their standard is and transparency into which ingredients are not allowed into their products (we wrote more about this point in this post).
• Organic – This falls under the jurisdiction of the USDA, and even that’s confusing! The labels “100% Organic,” “Organic,” and “Made with organic ingredients” have very different definitions ranging from 70% – 100% organic ingredients (excluding water and salt) [4], [5], [6]. 

2 – Finished personal care products

• The FDA defines a finished cosmetic product as follows: “The term cosmetic product means a finished cosmetic the manufacture of which has been completed” [11]. You might think that a completed product formulation and a sample of said product goes to the FDA for a safety review, but shockingly, the companies manufacturing the products are in charge of testing the safety of what they bring to market. According to the FDA “The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market” [1], [2], [3].

3 – Recall of unsafe products 

• There is no requirement for recalls to be done. The FDA has no oversight on dangerous products. They can request the brand to issue a recall, but the brand is under no obligation to comply. From the FDA recall policy page “FDA has no authority under the FD&C Act to order a recall of a cosmetic, although it can request that a firm recall a product” [9]. 
• While some companies are proactive about issuing recalls, some do nothing until there is public pressure, and even then, they may not follow through. The cost and logistics of buying back product (from retailers and customers) hurts the brand’s bottom line. It doesn’t trigger action – there’s no threat of criminal liability. For instance, in 2019 beauty influencer, Jaclyn Hill’s lipsticks were found to contain hair, holes, heat damage, random bits of plastic, and shards of metal. While social media outrage pushed the company to offer refunds to customers, they never formally recalled the product from retailers. This left countless contaminated products on store shelves causing more consumers to roll the dice on product they had no idea was tainted.[13]

How MADEWITH crafted our guidelines

MADEWITH appreciates the importance of the FDA’s role in public health and safety. With that said, there are many other countries that do a more thorough job regulating personal care & cosmetic products through a governing body. Canada’s Hotlist, the EU Commission, and the ASEAN Cosmetic Directive have all helped inform our Never MADEWITH List . Our approach to clean is to select products using the most current international regulation and scientific research. Our list is not set in stone, and we’re always ready to add to it as new information becomes available. 

1. FDA Cosmetic Regulation https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
2. The FD&C Act https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
3. Fair Packaging and Labeling Act https://wayback.archive-it.org/7993/20170722051950/https:/www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/ucm148722.htm
4. USDA Organic Standards https://www.ams.usda.gov/grades-standards/cosmetics-body-care-and-personal-care-products
5. USDA Organic labeling https://www.ams.usda.gov/rules-regulations/organic/labeling
6. The National Organic Program, USDA https://www.ams.usda.gov/rules-regulations/organic 
7. Poison Prevention Packaging Act of 1970 https://www.cpsc.gov/Regulations-Laws–Standards/Statutes/Poison-Prevention-Packaging-Act
8. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, Annex II https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32009R1223#d1e32-83-1
9. FDA Recall Policy for Cosmetics https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-recall-policy-cosmetics
10. The 11 ingredients banned by the FDA in cosmetics https://www.fda.gov/cosmetics/cosmetics-laws-regulations/prohibited-restricted-ingredients-cosmetics
11. Definition of “finished cosmetic product” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=700.3
12. Number of Lobbyists to the FDA in 2021 https://www.opensecrets.org/federal-lobbying/agencies/summary?id=135 
13. Jaclyn Hill Contaminated Lipstick https://www.bbc.com/news/newsbeat-48745293