Why Small Sunscreen Businesses Are Paying the Biggest Price with New FDA Regulations

A new rule announced earlier this year by the Food and Drug Administration will drive up the costs for many small sunscreen companies. Specifically, rising regulatory fees may actually reduce consumer choice and inhibit green innovation in the market. The new ruling requires small manufacturers to pay a $20,322 new fee to be compliant with FDA regulations for sunscreens and over-the-counter (OTC) drugs.

Part of the CARES Act, which provided economic relief for most Americans during the pandemic, contains a very expensive provision for small OTC (over-the-counter) manufacturers.

Any sunscreen is considered an OTC product but this new law requires that ALL manufacturers – whether we operate a small facility in Florida or have factories around the world like the big boys – pay an annual fee of $20,322. Unlike other fees set by the federal government, there is no provision that recognizes the difference that makes to a small business. Florida Representative Greg Stube has introduced a bill that would offer a small business provision that was omitted during the rush to pass the CARES Act. The bill, however, is stuck without support from other congressmen.

We’re asking our advocates and customers to reach out to their congressmen to sign on as co-sponsors to Rep. Stube’s bill. We’ve attached a sample letter that you’re welcome to modify and here’s a link that sends your comments directly to your congressman or woman: https://www.house.gov/representatives/find-your-representative

SAMPLE LETTER, PLEASE FEEL FREE TO EDIT:

Dear Congressman ……………..

Innovation is as American as apple pie – unless onerous user fees stifle it.

The “Sunscreen Innovation Act” does just that, stifling all OTC drug manufacturers with a $20,322 annual fee, and a $100,000 to $500,000 monograph fee, with no concern or concession to the size of the business.

I am your local constituent and am writing today to ask that you co-sponsor Greg Steube’s Small Business FDA User Fee Adjustment Act. This bill creates a small business provision in the FDA’s new OTC Monograph fee which was omitted during the rush to pass the CARES Act.

As a strong supporter of innovation in sunscreen, I believe that it’s unfair to charge the same fee to a small business creating innovative products as it does a multinational corporation with factories around the world.

The proposed bill wouldn’t waive the new fee entirely – as was the case with companies who started manufacturing hand sanitizers at the peak of the pandemic. It just allows a provision for the small businesses who are the backbone of this country, and are struggling to survive. Some details since it’s somewhat buried in the 247-page bill:

• The current legislation provides FDA with the authority to assess and collect annual facility fees from owners of qualifying over-the-counter monograph drug facilities. The prior fee was $0.00.

• The $16,040 fee was originally filed in December, but was withdrawn due to public outcry by sanitizer manufacturers. It was reissued excluding sanitizer manufacturers and increased to $20,322.

• Other fees, notably the medical device user fee, have provisions for small and mid-sized businesses.

• Congressman Steube’s Small Business FDA User Fee Adjustment Act of 2021, now pending in the Energy and Commerce Committee, adds in verbiage that brings the user fee in line with other fees of its kind.

I am respectfully requesting that your office intervene immediately to correct this undue burden and lend support to Congressman Steube’s bill. Thank you for your attention.

Sincerely,

Autumn Blum
Formulator & CEO

From Stream2Sea – Protect what you love 

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