Sign up for our Newsletter. FREY M. Let's be friends! Topics Anti-aging. Industry Regulations. Product Application. Product Ingredients. Product Selection. Skin Conditions. Skin Function. Skincare Products. I know. Your Bug Bite Stick works well for soothing the hurt and itch of insect bites.
Your friends and family report that it is magical. Your Pain Balm heals scratches and minor burns. Still, these products are considered drugs by the FDA and are required to undergo clinical testing to prove that they work prior to selling.
If not, they are still considered drugs, but unapproved drugs. Cosmetics, on the other hand, are only meant to cleanse or make the person look better.
Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle pain, it's a drug. How are the laws and regulations different for cosmetics and drugs? The following information is not a complete treatment of cosmetic or drug laws and regulations. It is intended only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling.
These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded. Certain OTC drugs may remain on the market without an NDA approval until a monograph for its class of drugs is finalized as a regulation. A note on the term "new drug": Despite the word "new," a "new drug" may have been in use for many years. If a product is intended for use as a drug, it must comply with the requirements outlined above. How are good manufacturing practice requirements different?
Good manufacturing practice GMP is an important factor in helping to assure that your cosmetic products are neither adulterated nor misbranded. How are registration requirements different? As its name indicates, this program is voluntary. A cosmetic product must be labeled according to cosmetic labeling regulations.
See the Cosmetic Labeling Manual for guidance on cosmetic labeling and links to the regulations related to cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in descending order of predominance as "Inactive Ingredients.
Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word.
Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when. Please direct questions about these products, such as safety and labeling requirements, to CPSC.
If a cleanser does not meet all of these criteria
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