Tag: Cosmetics FDA

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

ALPHA HYDROXY ACIDS

AHA are used in some cosmetics and drug products applied to the skin. Cosmetic products containing AHAs are marketed for a variety of purposes, such as smoothing fine lines, improving skin texture and tone, unblocking pores etc. AHA containing products cause exfoliation or shedding of the surface skin. The extent of exfoliation depends on the concentration of AHA and other ingredients in the product.

Some products that contain high concentration of AHAs or other acids act as skin peelers. Such products are regulated as drugs by FDA. For example, acne treatment products or skin lighteners are considered drugs. FDA has received many adverse reports for AHA containing products listing adverse reactions such as skin burning, peeling, rash, swelling, blisters, increased sunburn etc. FDA has found that applying AHAs to skin results in increased UV sensitivity.

FDA recommends using AHA containing products strictly according to the label directions. It is advisable to use skin protection. FDA also recommends that the labeling of a cosmetic product bear a statement that conveys the following information:

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Liberty Management Group Ltd can help you make sure all elements of your product label are compliant to FDA regulations. LMG provides a wide range of services assisting companies with label compliance, ingredient compliance, FDA registration etc.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: August 29, 2019

Color Additives in Cosmetics

FDA regulates cosmetic products and its ingredients. Color additives are added to cosmetic products to improve their appearance. Color additives are subject to strict system of approval under the FD&C Act. Failure to meet US color additive requirements may cause a cosmetic to be adulterated and make it subject to detention at the port of entry.

The FDA requirements for color additives that are added to cosmetics are as follows:

  1. All Color additives must be approved by FDA. There must be a regulation specifically addressing a substance use as a color additive, specifications and restrictions.
  2. Along with approval, many color additives are also required to be batch certified by FDA if they are to be used in cosmetics marketed in the US. This means that FDA chemists have analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation—called a “listing regulation”—for that color additive. FDA determines the need for batch certification based on whether the color additive needs this level of control to protect the public health. Some color additives, in their uncertified forms, might contain impurities at levels that pose a health concern.
  3. Color additives may only be used as stated in the regulations pertaining them including maximum permissible concentration in the finished product.

FD&C Act categorizes color additives into two main types:

  1. Those subject to certification – Petroleum based color additives aka coal tar dyes or synthetic organic colors. Such colors usually have 3-part names e.g.; FD&C Yellow No. 5
  2. Those exempt from certification – Obtained primarily from mineral, plant or animal sources.

A list of color additives approved for use in cosmetics can be found here https://www.fda.gov/industry/color-additives-cosmetics/color-additives-listed-use-cosmetics-code-federal-regulations

Some color additives are approved for use for one use and excluded for use in another.

To ensure that the cosmetic products do not contain any unapproved color additive or other unapproved ingredients, a manufacturer can avail LMG’s label and ingredient review service.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 03, 2019