FDA regulations are harder to keep up with than the changes to income taxes every year! At best, it’s very nearly impossible for an entrepreneur to keep up with what’s okay with the FDA and what’s not. As well as regulations applying to your actual product, the FDA even has something to say about your packaging requirements.
The following are some regulations by the FDA that should be first and foremost in the minds of cosmetics product manufacturers.
Each and every ingredient contained within a product, as well as the overall product itself, must be deemed, as long as it is used as intended, as safe. The controlling company or manufacturer is solely responsible for seeing to this.
Supplies and product ingredients must be stored in a safe and clean manner. And a defined manufacturing process must be in place for every business. At any point in time, in order to determine manufacturing conditions, the manufacturing facilities can be inspected by the FDA. They will be looking for misbranding, adulterated cosmetics, and overall manufacturing safety.
There are specific labeling requirements put forth by the FDA including, but not limited to, the fact that labels most contain the following:
- The distributor or packer
- Manufacturer’s address
- Address and name of the business
There are exemptions that can apply in certain instances. Exemptions and details can be found in section 701.9 of Title 21 of the Code of Federal Regulations put forth by the FDA.
Cosmetics Classified As “Organic”
There is a specific regulation regarding the use of “organic” as a term that applies to a product. It pertains to cosmetics, even though it wasn’t written for cosmetics. Three main topics regulate the use of the word organic:
Check online, at the FDA’s website, for detailed information regarding organic labeling (i.e., various required percentages, definition of organic ingredients, etc.)
Regulations on Hybrids
A product is considered by the FDA to be both a drug and a cosmetic if it causes a change or improvement in appearance (i.e., cure or protection/prevention). Requirements relating to both drugs and cosmetics are rules and regulations to which this type of product must adhere. Requirements for drugs are far more robust than are cosmetics requirements.
The following would be considered hybrid products:
- SPF protection makeup and moisturizers
- Deodorants and antiperspirants
- Anti-dandruff shampoos
That small list of three products will come as a huge surprise to some people! Imagine, your deodorant or dandruff shampoo being classified as a drug. But the FDA is very strict and will not hesitate to enforce the rules and regulations no matter the damage to the reputation or marketability of a product or company.
So, better safe than sorry.
Entrepreneurs have enough to worry about without having to concentrate on each and every FDA rule and regulation. It’s hard keeping up with the FDA! Today’s astute business person partners with professional organizations that can assist them in things like distribution, promotion, branding, packaging, manufacturing, testing, product formulation and development, and yes, any regulatory concerns that there may be.