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Law Educator, Esq.
Law Educator, Esq., Attorney
Category: Legal
Satisfied Customers: 116751
Experience:  JA Mentor -Attorney Labor/employment, corporate, sports law, admiralty/maritime and civil rights law
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I'm developing a dental opposed to a paste,

Customer Question

I'm developing a dental opposed to a paste, powder, or ointment. Is it a considered a cosmetic? Should the ingredients be protected? What is my liability?
Dr. Loretta
Submitted: 1 year ago.
Category: Legal
Customer: replied 1 year ago.
Expert:  Sam replied 1 year ago.

Hello Dr. Loretta

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics 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)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.

Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug.

Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

Customer: replied 1 year ago.
Thank you Sam... Perhaps I should've mentioned in my question that I am aware of the above ACT having researched it as well. However, the question remains if I don't make any medical/dental claims(i.e, anti-cavity) -can I market it as a cosmetic and am I protected by the cottage law(making product at home) and sell it?
Customer: replied 1 year ago.
Additional, my product does not contain fluoride... Natural/holistic ingredients not known to generally cause harm. Do I patent... Copyright ingredients if that's possible?
Expert:  Sam replied 1 year ago.

Thank you. Unfortunately the FDA and even the Ohio Cottage laws are very complicated. I am not going to be able to help you further but to provide you with the Statute and you may want to review this decision by the FDA as it pertains to Toms of Maine Natural Mouthwash.

I would suggest that you would want to patent your brand, once it is developed.

I will opt out now. And perhaps another professional here can be of greater assistance to you. There is no need to reply here further as that may delay another professional responding. And there is no need to rate my information and your deposit will remain on balance.

Thank you and good luck

Expert:  Law Educator, Esq. replied 1 year ago.
Thank you for your question. I look forward to working with you to provide you the information you are seeking for educational purposes only.
Regardless of what you call your product, a paste, a powder, a cream, if it is going into the mouth, even to rub on the gums it is regulated under the Act, no different than a mouthwash or a toothpaste. Also, the FDA considers anything that goes into the mouth such as a toothpaste or mouthwash, and a cream like you describe would fit into that as it goes into the mouth, as a personal care product they treat like a drug. If it contains all natural ingredients, then it does not need to undergo testing/approval like some other products.
No matter even if it is an approved FDA product or if it is not, if your product causes any harm to anyone you are liable for all the damage it may cause including pain and suffering under the product liabilities law.
If the combination of these ingredients is proprietary and you want to protect it, then you indeed should patent it as you said you were likely going to do.