Under these laws, cosmetic products and ingredients, with the exception of color additives, are not approved by the FDA before they go on the market. However, cosmetics must be properly labeled and must not be adulterated. For example, they must be safe under the labeled or customary conditions of use.
The ingredients (except certain colors) and labeling of cosmetics, such as many perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations do not require FDA approval. However, under the law, cosmetics must not be "adulterated" or "misbranded.”
The Food and Drug Administration (FDA) has the authority, generally under the Federal Food, Drug, and Cosmetic Act (FFDCA), to regulate cosmetic products and their ingredients. In this context, the agency's primary regulatory responsibilities include ensuring that cosmetics are not adulterated or misbranded.
The FDA regulates a wide range of products, including foods (except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); human and veterinary drugs; vaccines and other biological products; medical devices intended for human use; radiation-emitting electronic ...
Cleansing products, many of which are marketed as “soap,” may be cosmetics or drugs regulated by FDA, or consumer products regulated by the Consumer Product Safety Commission, depending on how they are made or how they are intended to be used.
Products intended to cleanse or beautify are generally regulated as cosmetics. Some examples are skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, shampoos, permanent waves, hair colors, toothpastes, and deodorants.
Look up the drug or biological product in Drugs @ FDA.
Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number.
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
And some products — such as cosmetics and dietary supplements — can generally be marketed with no prior approval. At the heart of all FDA's medical product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks.
Under U.S. law, cosmetic products and ingredients do not need FDA approval before they go on the market. The one exception is color additives (other than coloring materials used in coal-tar hair dyes), which must be approved for their intended use.
Cosmetics, including skin moisturizers, makeup, nail polish, shampoos, hair color, and deodorants, are predominantly regulated by the Food and Drug Administration (FDA).
Do I need to have my cosmetic products or ingredients approved by FDA? The law does not require cosmetic products and ingredients, except for color additives, to be approved by FDA before they go on the market. However, cosmetics must not be adulterated or misbranded.
The U.S. Food and Drug Administration regulates bottled water products, working to ensure that they're safe to drink.
FDA's legal authority over cosmetics is different from our authority over other products we regulate, such as drugs, biologics, and medical devices. Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives.
FDA regulates about 75 percent of the U.S. food supply. This includes everything we eat except for meat, poultry, and some egg products. There are over 19,000 prescription drug products approved for marketing. FDA oversees over 6,000 different medical device product categories.
The FDA does not regulate the practice of medicine, medical services, the price or availability of medical products and whether they are reimbursed by health insurance or Medicare.
adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards; misbranded, meaning the labels contain false or misleading information; an unapproved new drug; forbidden or restricted for sale.
The Big 6 foodborne pathogens, according to the FDA, include Norovirus, Salmonella Typhi, Shigella, Shiga toxin-producing Escherichia coli (E. coli), nontyphoidal Salmonella, and the Hepatitis A virus.
To support its public health activities, the FDA relies on (1) annual funding that Congress provides for the agency, and (2) Congressionally-authorized user fees paid by industries that make and market FDA-regulated products, and paid by certain other entities.
FDA Approval is Required by Law
Federal law requires all new drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing. However, some drugs are available in the U.S. even though they have never received the required FDA approval.
The FDA regulates the sale of medical devices and monitors the safety of all regulated medical products. Before a medical device can be sold or marketed in the U.S., the FDA must approve or clear the device. The FDA clears the device for sale because it is substantially equivalent to already approved devices.
FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and "Notice of Inspection" (FDA Form 482) upon arriving at your plant.