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Since 1938, the Federal Food, Drug and Cosmetic Act (FD&C Act) has provided the Food and Drug Administration (FDA) with the authority to regulate cosmetics and personal care products. The Fair Packaging and Labeling Act (FPLA), enacted in 1967, enhanced the power of the FDA and the Federal Trade Commission (FTC) to regulate labeling and content disclosures of consumer commodities, which includes cosmetics and personal care products.
Both of these Acts contain numerous rules and regulations that manufacturers must adhere to; here is a guide to the eight most important of these FDA regulations for cosmetic and personal care product manufacturers:
1. Hybrid Regulation
If products improve the appearance and cause a change (improvement, cure or prevent/protect), those products are considered both a cosmetic and a drug by the FDA. Products of this type must adhere to requirements relating to cosmetics and requirements relating to drugs, the latter of which are more robust. Common examples of products that are both a drug and a cosmetic include anti-dandruff shampoos, antiperspirant-deodorants, moisturizers and makeup with SPF protection. Numerous personal care products also fall into this category, and manufacturers must ensure their products are compliant with both classes of regulation. Note that the FD&C Act does not recognize cosmeceuticals as a category; a product can only be a drug, a cosmetic or both.
2. Organic Cosmetics
The FDA regulates the use of the term “organic” under the National Organic Program (NOP) and the U.S. Department of Agriculture (USDA). While the NOP was not written for cosmetics, it does apply to cosmetics. The term “organic” is regulated in three main ways: production, handling and labeling. When it comes to labeling a product as organic, the legal labeling standards are based on the percentage of organic ingredients in a product. Generally, you cannot use the term “organic” on cosmetic labels unless you comply with the NOP. Third parties can provide organic certification to cosmetic manufacturers. More details on the definition of organic ingredients, and the various percentages required for organic labeling, can be found on the FDA’s website.
3. Product Labels
The FDA regulates the labeling of ingredients for cosmetic and personal care products via the FPLA. Whether cosmetic or personal care products are manufactured domestically or imported, they must comply with the FDA’s labeling requirements. Under the FP&L Act, the FDA also requires that labels contain the business’ name and address, as well as the address for the manufacturer, packer or distributor. An exemption can apply to cosmetics that are processed, labeled or repacked at an establishment other than where they were originally processed or packed. More details on exemptions can be found in the FDA’s Title 21, Code of Federal Regulations, section 701.9.
The FDA has strict labeling standards based on their established definitions of cosmetics, drugs, and soaps. Labels for these products must correspond to the FDA’s definition of each category. If the labels make claims relating to the manufacturing of the cosmetic, such as organic or not being tested on animals, those assertions would be enforced by this act as well. Finally, the required label information must be accurate regarding contents and weight, and the information should be prominent and conspicuous.
4. Cleanliness of Manufacturing
The FDA requires that businesses have a defined manufacturing processes, and that they store ingredients and supplies in a clean and safe manner. The FDA can inspect cosmetic manufacturing facilities to determine manufacturing safety, and if the cosmetics are adulterated (not stored safely) or misbranded (not produced as claimed) under the FD&C Act or FPLA.
5. Safety of Ingredients
The FD&C Act requires that every cosmetic product and its individual ingredients be substantiated as safe for the intended use. This is solely the responsibility of the manufacturer or controlling company. The FDA leaves the safety testing methods up to the discretion of the cosmetic company. According to the FDA, “the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information.”
The FDA also requires that cosmetics and drugs not contain any prohibited ingredients for each category. Safety expectations relate to the storage and transport of goods; they must be kept in safe conditions to prevent the products from soiling or becoming otherwise compromised.
6. Import and Export Regulations
The FDA works closely with U.S. Customs and Border Protection (CBP) to monitor cosmetic and personal care imports. Imported cosmetics are subject to examination by the CBP at the time of arrival in the United States. Imported cosmetics that appear to be adulterated or misbranded could be refused at the border because all imported cosmetics must comply with the same laws and regulations that apply to those produced domestically.
Depending on the country that the cosmetics or personal care products are being exported to, the intended country’s requirements may differ from FDA requirements. A product intended for export will not be considered adulterated or misbranded if it meets the specifications of the foreign purchaser, is not in conflict with the laws of the country to which it is intended for export, or is labeled on the outside of the shipping package that it is intended for export and not sold or offered for sale in the United States. Even if primarily exported, any cosmetic products sold or offered for sale in the United States must comply with all the FDA’s requirements.
7. Shelf Life Requirements
Under the general requirement that manufacturers are responsible for making sure their products are safe, the FDA considers determining a product’s shelf life to be a significant part of the manufacturer’s safety responsibility. Examples of how a product can become unsafe over time include bacteria and fungi introduced via fingers being inserted into a product, or safety preservatives breaking down over time and allowing bacteria and fungi to grow. Applicators also become increasingly exposed to bacteria and fungi each time they are used. Manufacturers must determine a timeline by which a product and its components (such as applicators) become unsafe or too degraded for continued use.
Personal care products that are classified as drugs, or both a cosmetic and a drug, must be tested for stability (see the regulations at 21 CFR 211) and are required to have expiration dates printed on the labels.
8. Looking Ahead: Future Regulations
The Personal Care Products Safety Act is currently being considered, and its progress should be monitored by cosmetic and personal care manufacturers. In short, the bill would mandate many items and give the FDA more oversight over beauty-product safety. This would include the FDA’s evaluation of specific ingredients for safety (vs. relying on manufacture evaluations), the ability to require recalls, additional publication of ingredient information, the labeling of ingredients deemed not safe for children and the ability to issue specific regulations on Good Manufacturing Practices as they relate to beauty products.
Are You Maintaining Compliance?
These are just eight areas to review; there are many more, of course. If you manufacture cosmetics and pesronal care products, be sure to vet every possible regulation to ensure compliance. If you need help making sure you are keeping everything above board when it comes to FDA regulations, consider looking into an ERP solution that provides automated compliance features.