Month: July 2019

Cosmetics vs Drugs

Cosmetics are defined by FD&C Act as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. For example, skin moisturizers, perfumes, lipsticks, fingernail polishes, cleansing shampoos, hair colors, and deodorants etc.

Drugs, on the other hand, are defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals.

Some products meet the definition of both cosmetic and drugs. For example, a cleansing shampoo is a cosmetic as its intended use is to cleanse the hair. An antidandruff treatment is a drug as its intended use is to treat dandruff. As a result, an antidandruff shampoo would fall under both cosmetic as well as drug. Another example is that of a toothpaste with fluoride, anti-perspirant deodorants, moisturizer with sun protection claims.

A product’s intended use is determined based on either the claims made on the label, advertisements, company website, general perception about the product in consumers mind or by the ingredients present in the product.

The FDA requirements of cosmetics and drugs are different. Below is an outline of the key differences:

  1. FDA approval – FDA does not approve cosmetics except for color additives. On the other hand, every new drug needs an approval or conformity to FDA’s OTC monograph.
  2. GMP – FDA has no set regulations for cosmetic GMP. There are only guidelines that cosmetic companies need to refer to. But for drug companies, FDA has laid clear regulations that drug companies need to comply with.
  3. FDA registration – Cosmetic registrations are voluntary. Drug Registrations and listings are mandatory.
  4. Labels – Cosmetic labels need to comply with cosmetic labeling regulations while OTC Drug labels require compliance to OTC drug labeling regulations and combination drugs requires compliance to regulations specific to combination product labeling.
  5. NDC number: Drug products are required to have a labeller code while cosmetics are exempt from the requirement

Liberty Management Group Ltd provides assistance with FDA Registration for Drugs and Cosmetic Establishments, Label compliance, US Agent service and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 31, 2019

Who regulates cosmetics for animals?

The Federal law defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles.

The Act specifically addresses cosmetics used on human body.

So, what about the cosmetics used on animals?

Cosmetics used on animals are commonly referred to as grooming aids. Animal soaps, shampoos and other products that are intended for cleansing or promoting attractiveness of animals are not regulated by FDA. So, the FDA requirements that apply to human cosmetics do not apply to animal grooming aids.

However, if such products are intended for any therapeutic purpose or if they are intended to affect the structure or function of the animal, they are subject to FDA regulations as new animal drugs. Such products can be introduced into US markets after FDA’s approval and compliance to all the FDA regulations regarding animal drug products.

Liberty Management Group Ltd. can help you classify your animal products into FDA regulated vs not FDA regulated category and help you with FDA regulations if required.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 17, 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