Your previous package indicated the product was for dryness, odor, and atrophy. Why does the new package omit the term "atrophy"?

Thank you for your inquiry. We understand your concern regarding the changes to the claims on our packaging.

Let me explain:

The US Food and Drug Administration (FDA) regulates the sale of drugs, foods, and cosmetics. According to FDA policy, only drugs can make claims about treating diseases. If a product is not classified as a drug, such as a cosmetic, it cannot make a disease claim.

This policy has been in place for many years, though specific enforcement has varied. This year, the FDA has decided to strictly enforce its policies, including those regarding product claims.

Consequently, all cosmetics must revise their product descriptions on their websites and packaging to avoid making any disease claims.

Dryness and odor are discomforts that can be alleviated with a moisturizer and deodorizer. However, atrophy may be considered a disease.

Our product is a cosmetic, not a drug. It is designed to relieve dryness and odor. While it may also help with atrophy, promoting this benefit could be construed as a drug claim, which we are not permitted to make.

For instance, a bottle of water can quench thirst (a discomfort) and prevent dehydration (a disease). The bottled water can claim to quench thirst but is not allowed to advertise that it can prevent dehydration for marketing purposes. Although true, such a claim is considered a disease claim and is therefore prohibited. Not all policies may seem perfect, but we are obligated to comply when a policy is enacted.

This explanation clarifies why we need to revise our claims to comply with FDA policy.

Mar 25, 2024

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