MoCRA REGISTRATION EXEMPTIONS
To be exempt from MoCRA registration, your company must be a small business and does not produce cosmetic products that fall into the non-exempt list.
Additionally, a facility and/or product that is subject to drug facility registration and drug and drug devices registration under chapter V of the FD&C Act, are exempt from MoCRA registration.
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WHAT'S A SMALL BUSINESS?
One whose average gross annual gross sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who does not engage in the manufacturing or processing of certain cosmetic products as described in the non-exempt product list.
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NON-EXEMPT PRODUCTS:
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Cosmetic products that regularly come into contact with the mucus membrane of the eye under conditions of use that are customary or usual. Examples may include, but not limited to, certain eye shadows, eye makeup removers, liquid or mucosal eyeliners, and false eyelash adhesives.
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Cosmetic products that are injected.
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Cosmetic products that are intended for internal use.
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Cosmetic products that are intended to alter appearance for more than 24 hours under conditions that are customary or usual and removal by the customer is not part of such conditions of use that are customary or usual. Examples may include, but not limited to, certain nail polishes, hair product dyes, eyebrow dyes, tattoo inks, and leave-on skin preparations.​
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COSMETICS THAT ARE ALSO DRUGS:
Products may be classified as both cosmetics and drugs based on their claims. If a cosmetic product is intended to treat or prevent disease or to affect the structure or function of the human body, it is also considered a drug. As a result, it must comply with all applicable FDA regulations for both cosmetics and drugs.
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EXEMPT BUT STILL WISH TO REGISTER?
REASONS TO VOLUNTARILY REGISTER
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U.S. AGENT REPRESENTATION
Continued ​assistance with all your MoCRA compliance questions.
A reliable point of contact for all your FDA concerns, offering specialized cosmetic expertise.
Assistance with Serious Adverse Event reporting.
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2. SERIOUS ADVERSE EVENT REPORTING
No matter the size of your business, all Serious Adverse Events must be reported with the FDA.​
USA provides assistance with providing necessary documentation and timely submissions to the FDA.
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3. STAY INFORMED ON FDA UPDATES
Receive the latest FDA guidance, updates, and news coverage via USA's Industry News & Updates alerts.​
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​4. BUYER'S PREFER REGISTRATION
Looking to sell your cosmetics to major retail outlets?
Reports show buyers look for vendors who are have registered with FDA, as it
demonstrates credibility and commitment to compliance.
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5. MOVE FROM SMALL BUSINESS TO BIG BUSINESS
As your company grows from a small business to a major player, compliance requirements will also increase. Stay ahead by ensuring compliance early, so you can focus on expansion without the stress of regulatory burdens later.
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6. DISCOUNTED RATES
As a small business, take advantage of the USA's discounted rates and save on voluntary registration compliance.
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