Know the subtle ways cosmetics differ from OTC drugs within FDA regulation
According to the FDA, cosmetics are defined by the way they are to be used: “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.”
Problems arise when cosmetics companies make drug or disease claims for their cosmetics products.
For example, if a cosmetic product claims that it will restore hair growth, reduce cellulite, or remove wrinkles, then these are considered to be drug-related claims. As a result, the product will then need to abide by the specific regulations relating to drugs. If you fail to understand these very subtle differences, you could face enforcement action by the FDA.
At FDA Atty, we help your business navigate the tightrope between cosmetics and OTC drugs according to FDA regulations. Here’s what we do:
Ingredient and label review: We ensure any claims your product makes on the packaging or in your marketing materials is in compliance with FDA rules and regulations for cosmetics.
OTC drug products: If you want to market your cosmetics product with drug claims, then you’ll need to meet the strict regulations of that industry. We guide you through the application process and ensure your business is in compliance.
Get clarity on the language you can use on your cosmetics packaging and marketing. Click the button below to contact FDA Atty to review the language and more.
How We Help
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation now.
Expert knowledge of FDA regulations that helps you strategically grow your business
Marc Sanchez has provided our company with expert advice and letters that have saved us time and money in dealing with the FDA. We have worked with many FDA attorneys and consultants in the past and they can't hold a candle to the knowledge and expertise that we have found with Marc.
Jeff Maier (VP Sales & Marketing)
I am truly impressed… Marc understands the workings of the regulatory agencies and this allows him to very effectively achieve the results that his customers want without creating an environment of confrontation. Beyond that, he has insight into the laws governing foods, supplements, and medicine that goes beyond that of the federal officials involved in these regulatory areas. This allows him to open avenues of compromise and agreement that would not have existed before he was brought to bear on the difficulty. Even as he produces compromise and agreement, it is clear that he holds his customer's interest at heart.
I have never found a more powerful and effective counsel.
Steven Frank CEO
Nature's Rite Remedies
Marc is incredibly intelligent, poised and able to make reasonable, timely recommendations about risk. Additionally, he is extremely organized, has a calm demeanor and has provided insightful counsel to me on many regulatory issues. I strongly recommend him.
Physician- Entrepreneur- Consultant
We retained Marc to answer some extremely time-sensitive and complex questions regarding COVID-19 and FDA regulations. Despite being overloaded with clients, Marc was very responsive and was able to provide us with the comprehensive answers we needed within 24 hours. This enabled us to respond quickly and effectively to the changing regulatory landscape. I strongly recommend using Marc and look forward to working together again in the future.