Tag: cosmetic labelling

Does the FDA approve cosmetic products or companies?

Cosmetics are articles that are intended to be rubbed, poured, sprinkled, sprayed or applied to human body for cleansing, beautifying, or altering appearance.

FDA does not approve cosmetic products or companies. Facilities that are engaged in manufacturing, processing & distribution of cosmetic products are required to comply with below FDA requirements under FDA’s MoCRA regulation.

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. It is the responsibility of cosmetic manufacturers or distributors to ensure the safety of their products.

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.

Liberty Management Group LTD  provides assistance with Cosmetic Product Registration, Cosmetic Product Listing, Label Review and other FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Lead Acetate in Cosmetics

Since 1980 lead acetate has been considered a safe color additive for use in cosmetics for hair coloring. In 2017, a color additive petition requesting repeal of regulation that allows for the use of lead acetate in cosmetics was submitted. After carefully reviewing the submission and other relevant information, FDA concluded that there is no reasonable certainty of no harm from this use of lead acetate. On October 30, 2018, FDA published a final rule banning the use of Lead Acetate in cosmetic products intended for hair coloring. The rule is effective from December 03, 2018 and the industry has 12 months to make the transition and reformulate their products. Such products must comply with the requirements of 21 CFR 73.2396, including the specifications, uses and restrictions, and labeling requirements.

Hair dye products containing Lead Acetate are required to bear such a warning statement:

CAUTION: Contains lead acetate. For external use only. Keep this product out of children’s reach. Do not use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after each use.

Manufacturers and labelers of cosmetic products must comply with FDA labeling requirements otherwise their products are considered misbranded and are subject to detention.

Liberty Management Group Ltd. can help companies with labeling compliance. Our label experts check your labels against current labeling regulations and help you avoid detention and import refusals.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 25, 2019

Are cosmetics FDA approved?

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

http://www.fdahelp.us

Published on: January 23, 2019