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.
Cosmetic Labeling and Claims

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.

Cosmetic Good Manufacturing Practice Regulation Audits

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 You will receive a detailed report outlining your current level of compliance against the Draft Guidance for Industry: Cosmetic Good Manufacturing Practices, with our recommendation as to what needs to be done to bring identified deficiencies into compliance.

Submission of Color Additive Petitions, Color Certifications

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.

Cosmetic Recalls

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.

Import Entry Assistance

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.

US Agent for Foreign Color Manufacturers

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 Voluntary Registrations

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.

483 and Warning Letter Responses

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.

Conducting Due Diligence Audits

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 Facility Inspections

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.

Cosmetic Employee and Management Training

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

Expert Witnesses in Legal Cases

In the industries regulated by FDA, such as those in the pharmaceutical, medical device, food, dietary supplement, and cosmetic business, compliance issues are of great importance. When disputes arise, the regulatory compliance status of a product or facility is often a key issue and can make a significant difference in how the matter will be resolved. In such cases, it is critical to have the assistance and advice of experts who are both experienced and knowledgeable in FDA regulations and industry practices, and who will be perceived as independent and objective. Whether a dispute is resolved via mediation or litigation it is imperative to have a well-respected and knowledgeable expert witness acting on your company’s behalf. EAS independent advisors and consultants are routinely called to serve as expert witness in a variety of cases and provide the in-depth, detailed attention required in these cases.

EAS offers one of the most experienced groups of consultants available on FDA regulatory compliance issues. We offer a team of former high-level FDA officials and industry professionals who will share their expertise with our clients. Our consultants have an average of over 25 years of regulatory experience and include some of the most well-known and highly respected names in the industry. As new standards and regulations proliferate, EAS keeps abreast of the changing regulatory landscape, allowing us to deliver up-to-the-minute policy advice to our clients. Our experts have the knowledge, qualifications, and experience necessary to explain and clarify the issues to our clients and the courts while establishing credibility and persuasiveness as witnesses.

EAS offers assistance in adjudicating insurance claims and servicing as an expert in depositions and civil litigation cases. With high-level experts in all areas of FDA regulations, EAS is well recognized as representing the industry in all manner of court cases.