Question 1

How to register cosmetic products in the U.S.A?

Accepted Answer

FDA's Voluntary Cosmetic Registration Program (VCRP) is a reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States. If you want to register a cosmetic product with the FDA you must open a VCRP account.  The online VCRP system can then be used to file an establishment registration (Form 2511).

Question 2

How much does it cost to get FDA approval for cosmetics?

Accepted Answer

There is no fee associated with cosmetics in the USA.

Question 3

How to register beauty products in the U.S.A?

Accepted Answer

In order to register your beauty products in the US you need to determine whether your products require registration, appoint an authorised agent, submit the regulatory dossier, and obtain the registration certificate.  If you need help with any of these steps let us know by emailing info@qualitysmartsolutions.com.

Question 4

What types of claims or standards can the FDA set?

Accepted Answer

Cosmetic claims include texts, images or symbols that are used by brands to present the characteristics of a cosmetic product and are a real advertising tool for customers.  Under the Federal Food, Drug and Cosmetic Act (FD&C Act) cosmetics must not be misbranded.  For example, all cosmetic products must be safe for consumers by being properly labelled with the customary conditions of use.

Question 5

Are there any ingredients that are prohibited for use in cosmetics?

Accepted Answer

The following ingredients are prohibited from being used in cosmetic products: mercury compounds, vinyl chloride, bithionol, halogenated salicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene.

Question 6

What are some examples of cosmetic products and non-cosmetic products?

Accepted Answer

Cosmetic products can include: soaps, manicure products, adhesives for use on the body, moisturizers, tattoo inks, makeup products, tooth whiteners and cleansing wipes. Non-cosmetic products would be things such as: sunscreens, acne treatments, skin whiteners/lighteners, hand sanitizers, collagen/botox injections, insect repellants, oral supplements and contact lenses.

Question 7

What are FDA cosmetic regulations?

Accepted Answer

Cosmetic regulations are laws and guidelines that govern the safety, labeling, and marketing of cosmetic products. These regulations are put in place to protect consumers from harmful ingredients and misleading claims, and to ensure that cosmetic products are safe for use. In the United States, cosmetic regulations are overseen by the Food and Drug Administration (FDA), while other countries may have their own regulatory bodies.

Question 8

Who regulates cosmetics in the United States?

Accepted Answer

In the United States, the Food and Drug Administration (FDA) is responsible for regulating cosmetics. The FDA has the authority to oversee the safety, labeling, and marketing of cosmetic products and can take action against companies that violate these regulations. Other countries may have their own regulatory bodies that oversee cosmetic products. It’s important for companies to understand the regulations in the countries where they sell their products to ensure compliance and protect consumers.

Question 9

What are the requirements for labeling cosmetics?

Accepted Answer

The FDA requires that all cosmetic products have a label that includes the name and address of the manufacturer, packer, or distributor, a list of ingredients in descending order of predominance, and the net quantity of contents. The label must also include any necessary warnings or precautions, such as “for external use only” or “keep out of reach of children.” Additionally, any claims made on the label or in advertising must be truthful and not misleading. Companies should consult the FDA’s labeling guidelines for more detailed information on the requirements.

Question 10

What are the restrictions on cosmetic ingredients?

Accepted Answer

The FDA regulates cosmetic ingredients to ensure they are safe for use. Some ingredients are prohibited or restricted due to potential health risks, while others are allowed but must be used within certain limits. For example, lead acetate is prohibited in hair dyes due to its potential toxicity, while hydroquinone is restricted to a maximum concentration of 2% in skin lightening products due to its potential to cause skin irritation and other adverse effects. Companies should consult the FDA’s list of prohibited and restricted cosmetic ingredients for more information.

Question 11

How are cosmetic claims regulated?

Accepted Answer

Cosmetic claims are regulated by the FDA to ensure they are truthful and not misleading. Companies must have scientific evidence to support any claims they make about their products, and they may not make claims that suggest the product can treat or cure a disease. The FDA also has specific regulations for certain types of claims, such as those related to sun protection or anti-aging. Companies should consult the FDA’s guidelines for cosmetic claims for more information.

Question 12

What is the Modernization of Cosmetic Regulation Act?

Accepted Answer

The Modernization of Cosmetic Regulation Act significantly impacts cosmetic product manufacturers. Under the new law, manufacturers must register their facilities with the FDA and provide the agency with a list of all cosmetic products they manufacture. They must also report any serious adverse events associated with their products to the FDA within 15 days of becoming aware of the event.

Plus, the FDA has the authority to order a recall of a cosmetic product if it is found to be unsafe or misbranded. Manufacturers must also comply with new labeling requirements, including listing all ingredients on the product label in order of predominance. Overall, the act places greater responsibility on cosmetic product manufacturers to ensure the safety and transparency of their products.

Question 13

How does MOCRA impact cosmetic product manufacturers?

Accepted Answer

The Modernization of Cosmetic Regulation Act significantly impacts cosmetic product manufacturers. Under the new law, manufacturers must register their facilities with the FDA and provide the agency with a list of all cosmetic products they manufacture. They must also report any serious adverse events associated with their products to the FDA within 15 days of becoming aware of the event.

Plus, the FDA has the authority to order a recall of a cosmetic product if it is found to be unsafe or misbranded. Manufacturers must also comply with new labeling requirements, including listing all ingredients on the product label in order of predominance. Overall, the act places greater responsibility on cosmetic product manufacturers to ensure the safety and transparency of their products.

Question 14

What are the new requirements for MOCRA ingredient labeling?

Accepted Answer

Under the Modernization of Cosmetic Regulation Act, cosmetic product manufacturers are required to list all ingredients on the product label in order of predominance. This means that the ingredient that makes up the highest percentage of the product must be listed first, followed by the next highest percentage, and so on. Additionally, any fragrance or flavor ingredients must be listed separately, and any color additives must be listed by their respective names. These new labeling requirements provide consumers with more transparency about the ingredients in the products they use and help them make more informed purchasing decisions.

Question 15

What are the new safety standards for cosmetic products?

Accepted Answer

The Modernization of Cosmetic Regulation Act significantly impacts cosmetic product manufacturers. Under the new law, manufacturers must register their facilities with the FDA and provide the agency with a list of all cosmetic products they manufacture. They must also report any serious adverse events associated with their products to the FDA within 15 days of becoming aware of the event.

Plus, the FDA has the authority to order a recall of a cosmetic product if it is found to be unsafe or misbranded. Manufacturers must also comply with new labeling requirements, including listing all ingredients on the product label in order of predominance. Overall, the act places greater responsibility on cosmetic product manufacturers to ensure the safety and transparency of their products.

Question 16

How can consumers stay informed about the MOCRA changes?

Accepted Answer

Consumers can stay informed about the changes brought about by the Modernization of Cosmetic Regulation Act by keeping up to date with the FDA's website and social media channels. The FDA regularly updates its website with information about new regulations and any changes that may affect consumers. Additionally, consumers can sign up for email alerts from the FDA to receive notifications about new safety alerts, recalls, and other important information related to cosmetic products. It's also important for consumers to read product labels carefully and to research the ingredients in the products they use to ensure they are safe and effective.

Question 17

What are the USA MoCRA and cosmetics labelling requirements?

Accepted Answer

Eventually, labelling is also impacted by the publication of the USA Modernization of Cosmetic Regulation Act. On top of the existing requirements, each cosmetic product shall be labeled with some additional mandatory information:

Contact details, and the possibility of a website through which the Responsible Person can receive adverse reaction reports.
A cosmetic product intended to be used only by a professional must be labeled with clear and prominent statement that the product is to be administered or used only by licensed professionals.
Last but not least, a list of ingredients including “allergens” must appear on pack. The precise list of labeled allergens shall be established by regulation.

Question 18

What is the Impact of the USA MoCRA on cosmetic ingredients and finished products?

Accepted Answer

First of all, an official method to detect the presence of asbestos in products containing talc will be published soon. PFAS are also impacted as the DFA must evaluate the use and safety of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products, including any risks associated with such use.

Besides, the USA cosmetics reform provides with an obligation to comply with Good Manufacturing Practices (GMPs). The GMP specific requirements will have to be published by the FDA within 3 years.

Next, the safety substantiation is also an important point of the Modernization of Cosmetic Regulation Act in the USA. Indeed, the Responsible Person must ensure and maintain records supporting that there is an adequate justification of safety. This point is not new, as a TRA ( Toxicological Risk Assessment) was already compulsory to have the right to sell cosmetics in the USA. BIORIUS experts have the knowledge to create a review of the toxicological profile of each ingredient and finished product, which will enable our toxicologists to determine the warnings that must be included on the cosmetics’ labels.

Question 19

Who is the mandatory Responsible Person for cosmetics in the USA?

Accepted Answer

As you may have seen in the previous paragraph, a Responsible Person is now a requirement in the USA for each cosmetic product. It must be the manufacturer, the packager or the distributor. Its name and address have to appear on the label.

Moreover, according to the USA Modernization of Cosmetic Regulation Act, the responsible person must:

Ensure and maintain records supporting the safety of the cosmetic product. This dossier must be available to the authorities if needed
Receive and take care of the adverse reactions (including reporting to the FDA when needed)
Keep and maintain up to date a cosmetovigilance dossier
Give the opportunity to the authorities to consult the component of the fragrance if needed
Notify the products and maintain this notification updated
Ensure that allergens are correctly labeled on the packaging
Organize a market recall when needed/requested by the FDA

Question 20

What does MoCRA mean for cosmetics companies?

Accepted Answer

The FDA will adopt rules under MoCRA that impact every stage of the production and marketing of your cosmetic items. New specifications include:

•	Required FDA registration of establishments for cosmetics
•	Required Product Listings for all cosmetics sold in the USA
•	Adherence to Good Manufacturing Practices (GMPs) mandated by the FDA for the Reporting of Adverse Events
•	Keeping records, including those of adverse events and safety justifications
•	Required Recalls
•	Allergen Statement for Fragrances

The bill offers general guidance so that cosmetic companies can begin planning for the new FDA Requirements, even though the FDA still needs to develop regulations.

Question 21

How will MoCRA impact cosmetic facilities?

Accepted Answer

Under MoCRA, the term "facility" includes any establishment that manufactures or processes cosmetic products distributed in the United States. Facilities will need to register and comply with GMPs issued by FDA.

Question 22

Do any facilities not require facility registration?

Accepted Answer

Yes, small businesses will have more flexible and simplified requirements. FDA defines a small business as a business with average gross annual sales in the U.S. for the previous 3-year period of less than $1,000,000, adjusted for inflation. This does not apply to any responsible person or facility engaged in manufacturing cosmetic products that:
•	Come into contact with eyes,
•	Are injected,
•	Are intended for internal use,
•	Or alter the appearance for more than 24 hours under conditions of use that are customary or usual.

Question 23

When are facility registrations and product listings required?

Accepted Answer

Facility registration and product listings are due by December 29th, 2023, for existing facilities. New facilities that manufacture or process cosmetic products for distribution in the U.S. must register within 60 days of marketing the product or 60 days after the deadline for existing facilities, whichever is later.

Question 24

How do I ensure all my cosmetic products are correctly listed?

Accepted Answer

MoCRA allows "flexible listings. "For flexible listings, companies can submit a single listing for cosmetic products with identical formulations or formulations that differ only in colors, fragrances, flavors, or quantity of contents.

Question 25

What are the new MOCRA Requirements for Labelling?

Accepted Answer

•	A U.S. address,
•	A U.S. phone number, or
•	Electronic contact information for receiving adverse event reports
Cosmetic products containing fragrance allergens must update labels to list these allergens. Professional cosmetic products must prominently indicate that they are to be used solely by licensed professionals and are compliant with existing cosmetic labeling norms.

Question 26

When will the new MOCRA requirements be put into effect?

Accepted Answer

Within one year: Professional cosmetics product labels must include all required information and state that only licensed professionals may use the product.
Within two years: Labels must include the responsible person's contact information for adverse reporting and identify fragrance allergens determined by the FDA.

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