Cosmetics are defined as articles intended to be rubbed, poured, sprinkled, sprayed or applied to human body for cleansing, beautifying, or altering appearance.
FDA does not approve cosmetics.
Under the law, cosmetic products and ingredients do not need FDA premarket approval. However, FDA can enforce action against cosmetic products on the market that are not in compliance with the law, or against establishments or individuals who violate the law.
It is a legal responsibility of cosmetic manufacturers or distributors to ensure the safety of their products.
All the cosmetics labels must be FDA compliant. Although FDA does not approve cosmetics labels, there are limits that apply to cosmetic labeling claims. As per law, all information on cosmetic labeling including claims must be truthful and not misleading.
If the FDA determines that a product is adulterated or misbranded, there are several actions the agency might take namely; criminal penalties, detention at port or file in an injunction to prevent the company from manufacturing the product.
FDA encourages cosmetic manufacturers and packers to register themselves by way of VCRP (Voluntary Cosmetic Registration Program) and submit the information of their products currently marketed in US by submitting CPIS (Cosmetic Product Ingredient Statement). Although the submission is voluntary, it provides FDA with an estimate of the information available on cosmetics and their ingredients, the frequency in which they are used and the establishments that are engaged in manufacture, packaging or distribution.
The submission of registration, filing of cosmetic product ingredient, assignment of registration number or CPIS number does not imply that the FDA has approved such establishment or its products.
Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with VCRP, CPIS, Label Review and many more FDA regulations.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us
Published on: January 23, 2019
can i get an NDC number for my skin moisturizer ? as per https://www.fdahelp.us/how-to-get-ndc-number-for-cosmetics.html NDC number is not for cosmetics.
Skin moisturizer comes under cosmetic regulations, cosmetics are not supposed to have an NDC number please visit https://www.fdahelp.us/fda-labeler-code.html for more about labeler code number.
but i see an NDC number for a sunscreen with SPF 45
FDA regulate sunscreen as a drug, not as cosmetic, you can find OTC Monograph ingredients for sunscreen at https://www.fdahelp.us/fda_otc/sunscreen.html
also please visit https://www.fdahelp.us/otc-drug-products.html for OTC Monograph drugs
do sunscreen without SPF on label consider as a drug ?
All sunscreens must be tested according to an SPF test procedure and the product “SUNSCREEN” is regulated as a drug in the USA. Please visit FDA site https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm258468.htm#Q3_What_does_the_SPF for more information.
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I am a Wholesale distributor of a hair products in US, am I eligible to register my company under FDA’s VCRP program?
Dear Sophia,
FDA’s Cosmetic registration program is only for the manufacturers and packers of cosmetic products. Since you are not either of them, you do not qualify. But you can still file Product Ingredient Filing for each of your products.
What is mean by ingredient filing of cosmetic products? do I need to submit VCRP before that?
FDA registration for cosmetic products is not mandatory. A manufacturer or distributor may choose to submit registration and/or ingredient filing. Under ingredient filing, the information about a products ingredients is submitted to FDA. An establishment registration is not a pre-requisite for filing an ingredient filing.
What are the benefits of VCRP registration?
VCRP is a voluntary cosmetic registration program that helps FDA in regulating the cosmetic industry better. If you are a manufacturer or packer of cosmetic products being sold in US, you can submit registration with FDA and receive a registration number. If you submit an Ingredient filing with FDA, you will receive an CPIS number. Some clients ask their suppliers for these numbers.