The purpose of regulatory agencies like the Food and Drug Administration is, of course, to make sure that products that reach consumers are safe and are marketed accurately. But the process involved is substantial. Companies don’t just send in a sample of a product, receive a certificate in the mail, and put the product on sale. Rather, the FDA looks at the entirety of a business’s manufacturing process, to make certain that production, packaging, warehousing, and distribution are done to high and consistent standards.

A company that meets these criteria is considered to follow good manufacturing practices, or GMPs.

What are good manufacturing practices, and how does the FDA verify that they’re being followed?

The origin of GMPs

In 1938, after a batch of tainted antibiotics killed over 100 people, President Franklin D. Roosevelt signed the Food, Drug, and Cosmetic Act, or FD&C Act, into law. Under the law, the FDA does not approve cosmetic products, but it does prohibit selling adulterated or misbranded cosmetics in interstate commerce. “Adulteration” essentially means “containing harmful substances,” and “misbranding” means that its labeling is incomplete or misleading. (For more in-depth definitions, see the FDA site.)

It is up to companies to ensure the safety of their products. If the FDA suspects otherwise, it may inspect company facilities. The FDA cannot force recalls of products, but if it becomes aware of violations of the FD&C Act, it may initiate legal action to remove products from the market or prevent them from being shipped. If warranted, it may even seek criminal prosecution.

An overview of GMP topics

The FDA provides a handy guide and checklist of good manufacturing practices for the cosmetics industry. It is clearly written and details common-sense ways to ensure that products and facilities are safe. In very broad, general terms (definitely refer to the relevant FDA documentation!), the GMPs say the following:

• Facilities should be large enough to accommodate all necessary personnel and equipment. They should be clean, sanitary, well-lit, well-ventilated, and in good repair.
• Equipment should be clean, sanitized, made of appropriate materials, and well-maintained.
• Staff should be well-trained and clean.
• Raw materials should be kept uncontaminated, intact, well-stored, correctly labeled, and well-organized. They should be tested, and those that fail the test should be controlled.
• Production should be subject to the same sorts of quality standards: cleanliness, good repair, approved materials, sample testing, clear labeling.
• Laboratory controls should ensure that proper procedures are followed: testing of raw materials, in-process samples, and finished products; proper storage of reserve samples of approved batches; regular water supply testing; contamination prevention.
• Recordkeeping and labeling should follow a specific set of criteria, so that products are thoroughly documented and tracked and packaging clearly, correctly, and completely informs the consumer about what’s inside.
• Complaint files should be kept, with detailed, specific data on each complaint received by the company.
• The company should not use any color additives not listed for use in cosmetics or not certified, or any prohibited cosmetic ingredients.
• The company should participate in the FDA’s voluntary cosmetic product and manufacturing facility registration program.

GMPs at the international level

The International Cooperation on Cosmetic Regulation is a voluntary group of cosmetics regulatory authorities from the United States, Canada, the European Union, Taiwan, South Korea, and Japan. Founded in 2007, it announced at its inaugural meeting that members would “take ISO standard 22716 on GMP into due consideration when developing or updating guidelines or other measures addressing GMP.” At that 2007 meeting, held in Belgium (see the meeting outcome document), the United States committed to “take into consideration the availability of the ISO standard as voluntary guidelines.”

ISO standard 22716

According to the ISO itself, the document “gives guidelines for the production, control, storage and shipment of cosmetic products.” These guidelines cover product quality but not plant personnel safety or environmental protection.

Note the key phrases “take into consideration” and “voluntary” in the United States’s commitment. (The following year, the USA confirmed the “take into consideration” wording and said it would modify FDA guidance.) To our knowledge, the FDA has not made further moves in the direction of making ISO standards, or any other registration or GMP issues, more mandatory than they currently are.

The take-away

While GMPs are voluntary, following them will result in cosmetics that are safe and accurately labeled -- and that isn’t optional.

Goldn’s mission is to make formula-based product development easier by enabling faster and simpler collaboration between Creators and Suppliers, starting with the Cosmetics Industry.

If you’re a cosmetic Creator, a professional regulatory consultant could be very useful as you navigate all the requirements and recommendations. If you’re a consultant, you can use Goldn to help new clients make sure they have all their ducks in a row.

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