Cosmetics

 

FDA regulated the cosmetic industry under the authority of the Federal Food Drug & Cosmetic Act and the Fair Packaging and Labeling Act. Cosmetics are defined by their intended use 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” (FD&C Act, sec. 201(i)).Cosmetics include products such as:

  • skin moisturizers
  • perfumes
  • lipsticks
  • fingernail polishes
  • makeup
  • cleansing shampoos
  • permanent waves
  • hair colors
  • deodorants
  • Any substance intended for use as a component of a cosmetic product.

If you would like additional information or discuss how EAS can help your firm please contact us!

Cosmetics are defined by their intended use 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”. Claims can be the defining difference to whether FDA will consider your product to be a cosmetic or a drug.

EAS can assist you in ensuring your cosmetic labels are in compliance with FDA regulations by reviewing your labels and crafting claims that help keep your product regulated as a cosmetic. We will review your ingredients for safety, and ensure that the correct ingredient name is used in your ingredient statement.

There are products that meet the definitions of both cosmetics and drugs when they have two intended uses, such as:

  • Anti-dandruff shampoo which claims to reduce dandruff
  • Deodorants making antiperspirant claims
  • Makeup and moisturizers with sun protection claims
  • Toothpaste containing fluoride

These products must comply with the requirements of both cosmetics and drugs. With our team of cosmetic label experts and OTC drug label experts, EAS can assist cosmetic companies with all their needs.

EAS has former FDA investigators, laboratory personnel, and industry quality experts available to conduct GMP/Quality Systems audits of your suppliers, contract manufacturing and laboratory facilities to assess compliance with applicable FDA and state regulatory requirements as well as established best practices. Our assessments are thorough and complete. You will receive a detailed report outlining your current level of compliance against the Draft Guidance for Industry: Cosmetic Good Manufacturing Practices, with our recommendation as to what needs to be done to bring identified deficiencies into compliance.

EAS can make recommendations and provide assistance with FDA submissions for your product(s). With scientific experts in toxicology, radiology, chemistry and biology and authorities in government laws and regulations, EAS’ consultants can lead your company through the process of obtaining necessary background data, filing the submissions, and following-up as needed during the submission process.

  • Ingredient Premarket Approval and Color Additive Petitions: EAS can work with your company to prepare and submit color additive petitions as well as compile toxicology reports and studies to determine ingredient safety, or design clinical studies to document ingredient safety and substantiate label claims.
  • Colors for FDA Certification: Color additives are subject to FDA approval, and in some cases, each batch must be certified by the FDA, before they may be used in products that come in contact with the bodies of people or animals for a significant period of time. EAS offers submission services for firms manufacturing dyes for all FDA regulated products.

FDA is not authorized to require a recall of cosmetic products however they may request companies to do so. From ingredient/component suppliers to manufacturing/processing/labeling, to the distribution of the products within the U.S. market, firms should take a proactive approach to ensure the safety of their product and reduce the potential for a recall. And sometimes a recall is the best course of action. EAS can assist with the performance of a mock recall to assess your readiness to execute an actual recall.

In general, the cosmetic company itself initiates a voluntary recall. A recall may require removing the product from the marketplace entirely or taking corrective actions to fix the problem.

In the unfortunate event of a recall, EAS can quickly and thoroughly assist in formulating an action plan to remove and correct the situation which warranted FDA’s attention. Assisting your company in bringing your products back to the U.S. marketplace in a manner that meets FDA’s requirements is our priority.

EAS offers import entry assistance for foreign firms whose products are in detention. Our consultants work with FDA and Customs Border Patrol to determine the reason for detention and assist clients in developing and executing a remedy allowing for the expedited release of affected products. Working as a foreign company’s US Agent, EAS offers the best in regulatory solutions for your most pressing import needs.

Cosmetic manufacturers, distributors, and packers are encouraged to voluntarily participate in FDA’s Voluntary Cosmetic Registration Program (VCRP) online registration system and list their manufacturing and/or holding facility locations. EAS can assist with questions related to registration and the completion of the online forms.

EAS is staffed with former FDA investigators and industry auditors that are available to audit firms that your clients are either considering purchasing or have an interest in having contract work performed by. Before they invest in such a firm, EAS can assess their current level of compliance with FDA Good Manufacturing Practice regulations and identify what it will take to bring these facilities into compliance. By having EAS on their due diligence team, costly mistakes can often be avoided.

Foreign color manufacturers and cosmetic firms exporting products to the U.S. must have a US Agent on file with FDA. EAS acts as a US Agent for foreign firms offering a conduit of information and understanding of communications received from the Agency.

Cosmetic manufacturers, distributors, and packers are encouraged to voluntarily participate in FDA’s Voluntary Cosmetic Registration Program (VCRP) online registration system and list their manufacturing and/or holding facility locations. EAS can assist with questions related to registration and the completion of the online forms.

In the event that FDA issues a 483 or warning letter or the Department of Justice files a consent decree, EAS can assist with a timely and appropriate response. EAS also assists as a third-party expert for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements.

EAS is staffed with former FDA investigators and industry auditors that are available to audit firms that your clients are either considering purchasing or have an interest in having contract work performed by. Before they invest in such a firm, EAS can assess their current level of compliance with FDA Good Manufacturing Practice regulations and identify what it will take to bring these facilities into compliance. By having EAS on their due diligence team, costly mistakes can often be avoided.

FDA must be permitted to inspect the facility at any time in accordance with the FD&C Act to determine compliance with FDA regulations for safety and to identify any potential problems before the products enter the U.S. marketplace.

EAS Consulting Group is available to provide a mock FDA inspection of foreign facilities to determine deficiencies and/or to develop a corrective action plan either before FDA makes its initial inspection or if FDA finds deficiencies that need correction.

EAS is frequently requested to bring our popular public training programs in-house, offering a dedicated training for employees and customizing the content as-needed to focus on specific areas of need.  Let bring one of our in-house training programs to your facility, customized for your specific needs, or join us at one of our upcoming training programs coming to a city near you.

  • Cosmetic Good Manufacturing Practices (GMP) Overview