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Cosmetics

EAS Consulting Group provides consulting services to the cosmetic industry, regulated under the authority of the Federal Food Drug & Cosmetic Act and the Fair Packaging and Labeling Act. Whether you need assistance with evaluating the safety of your formulation, label reviews, submission of a color additive petition, the Voluntary Cosmetic Registration Program, or determining if your product is a cosmetic, OTC drug or cosmetic/drug combination, EAS is here to help. While they have no GMP requirements, it is imperative to ensure safe production and distribution, including co-packers, of these products.

Overview of Cosmetics Services

Cosmetic Labeling and Claims

EAS team of labeling experts can review your product for appropriate labeling, claims substantiation, as well as design labels to meet FDA compliance and preventing misbranding.

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 crafting claims that help keep your product regulated as a cosmetic. We will review your ingredients for safety, ensure that the correct ingredient name is used in your ingredient statement and ensure that your labels are in compliance with FDA and FTC regulations. Incidentally, while the term “cosmeceutical”, or a product that is a combination of a cosmetic and a drug is commonplace in the market, the FD&C does not recognize this as a product category.

Submission of Color Additive Petitions, Color Certifications

EAS provides assistance with FDA submissions. Our scientific experts and authorities in government laws and regulations can lead your company through the entire process from obtaining necessary background data to preparation and filing, and on through FDA follow-ups.

Ingredient Premarket Approval and Color Additive Petitions: EAS helps cosmetics companies prepare and submit color additive petitions to FDA. Our toxicologists prepare complex reports demonstrating ingredient safety and design of clinical studies to document ingredient safety and substantiate label claims.

Colors for FDA Certification: EAS works with color manufacturers, submitting color additive samples and tracking certification data on client’s behalf. These 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. Contact us for more details on the requirements for your particular product and dye.

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 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 with each section of the GMP rule, with our recommendation as to what needs to be done to bring identified deficiencies into compliance.

Cosmetic Voluntary Registrations

EAS assists with facility registrations of manufacturing facilities as well as registration of products under the Voluntary Cosmetic Registration Program (VCRP) listing manufacturing and / or holding facility locations.

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EAS has a packed webinar schedule this winter. From Codex requirements to streamlining Drug Master Files to how Unique Device Identifiers can facilitate your product safety to using Active Managerial Controls in food safety oversight, our consultants can help you to better understand your business… and your FDA requirements. Click here to see our full schedule and to register.

Cosmetics Claims – Words Do Matter

In the competitive cosmetics world, discerning consumers are carefully considering product purchases to determine which offer the results they are hoping to achieve. In response, the pressure on marketing and labeling teams may entice to push the envelope with regards to product claims. However, words do matter, particularly in the eyes of FDA.

The manner in which labels are worded and claims are made can make all the difference in a cosmetic product inadvertently being marketed as an unapproved drug. Once a company has crossed that line, FDA takes notes and immediate changes to the marketing strategy to correct the errors or the product will be forcefully pulled from the market with potential liability risks for the company and product owners.

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