Ruining The Mood, US FDA Says Glycerin, Oleate Cream Not Approved As OTC Contraceptive

Smart Women’s Choice promotes its namesake brand topicals with claims including “One hundred percent hormone-free, completely safe, natural birth control that cannot fail when used as directed and causes no harmful side effects,” FDA warning says.

Emergency contraceptives are available OTC in the US and numerous types and brands of daily oral contraceptives are approved for Rx distribution as are contraceptive devices. The Food and Drug Administration has informed a California business that its topical labeled as a vaginal cream isn’t one of them.

Smart Women’s Choice Inc. promotes its namesake brand topicals on its websites and its social media pages with claims including “One hundred percent hormone-free, completely safe, natural birth control that cannot fail when used as directed and causes no harmful side effects,” according to a warning letter the offices of Unapproved Drugs and Labeling Compliance and of Compliance in the FDA’s Center for Drug Evaluation and Research published on 25 May.

The La Jolla business website states the product contains water, glycerin, potassium oleate, palmate, castorate, citrate and mono- and di-glycerides. It contains no hormones,

Smart women's choice offers its namesake brand vaginal cream in single or two-vial packages and in a large size at prices between $38.50 and $100, in one-time and subscription purchases. Source: screenshot

Glyercin is commonly available in the US in wound and burn treatments and as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritation.

The other ingredients are common in cosmetics and personal care lotions or foods: potassium oleate is a fatty aced with soap properties; castorate has cleansing, emulsifying, dispersing, solubilizing, lubricating and foaming qualities; mono- and di-glycerides are fatty acid chains that act as surfactants and are commonly used as emulsifiers to stop water and oil from separating.

Palmate commonly is defined as a natural leaf. Smart Women’s Choice doesn’t explain the ingredient’s role in its products; it doesn’t make labeling for the product available on its website.

Smart Women’s Choice, according to the FDA warning, also claims its “patented vaginal contraceptive cream is the ONLY healthy alternative to prevailing medical options.”

The business also claims “hormone-based pills, patches and mechanical devices, whose dangerous side effects include: sleeping disorders, fatigue, depression, reduced libido, personality changes, blood clots, increased risk of breast or cervical cancer, stroke and more!” according to the warning.

The business provides directions for use on its website. It involves applying, "after foreplay" and immediately preceding coitus,  "an amount equivalent to the size of a salted peanut." Post-coital rinsing is optional.

Unapproved, Not GRASE

The FDA regularly finds dietary supplement products, and less often food and topical products, marketed with claims for preventing or treating diseases and other health conditions, violations which render them unapproved drugs under the agency’s regulatory framework.

A lotion available OTC and marketed with claims as a contraceptive is a rare find for the FDA. Still, the letter submitted on 19 May to Smart Women’s Choice states the same explanation that the agency has stated to other firms around the world about their products being noncompliant.

The firm’s product “is not generally recognized as safe and effective for its above referenced uses and, therefore it is a ‘new drug’ under” FDA’s regulations. Drugs that are not OCT monograph products “may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, which “approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for your product,” the warning states.

The warning also notes CDER officials reviewed Smart Women’s Choice’s websites and social media posts from February through April, and also included claims made on social media in January.

Approval of any type of drug for US sales, including some OTC products, involves rigorous and lengthy reviews and evaluations by the FDA. While the large majority of OTC drugs are available under the agency’s OTC drug monographs and are not evaluated individually, the monographs set rigid and detailed criteria for each formulation and indication.

Waiting For OTC Daily Oral Contraceptive

No daily oral contraceptive is approved for OTC sales in the US, a policy due more to political influences than to the absence of evidence showing a product can be safely used without the intervention of a medical professional.

HRA Pharma SA, working with women’s health and reproductive rights advocacy group Ibis Reproductive Health, has conducted clinical trials to support a new drug application to FDA for making a daily oral contraceptive available OTC. The firm and the non-profit continue working to convince the FDA to approve OTC sales of progestin-only oral contraceptives with norgestrel 0.075 mg. (Also see "Oral Contraceptive OTC Proposal Moves Closer With Start Of Actual Use Study" - HBW Insight, 21 Jun, 2018.)

Political influences nearly prevented the FDA’s initial approval of nonprescription sales of Plan B (levonorgestrel 0.75 mg/2 dose) in 2006, and the clearance came only after the sponsors volunteered to restrict access to consumers 17 and over and to require sales from the behind the counter at pharmacies. (Also see "Teva Plan B OTC Application Fails Political Test After Clearing FDA Hurdle" - Pink Sheet, 12 Dec, 2011.)

Influences other than scientific research and public health needs continue swaying the FDA’s decisions on allowing broader access to the drug until years-long litigation by women’s reproductive rights advocates led to multiple orders by a federal court instructing the agency to allow lift the age restriction and allow actual OTC sales and also to allow sales of generic equivalents of Plan B One-Step, a single dose of 1.5 mg levonorgestrel, without age-restrictions on labeling that the innovator argued should be used. (Also see "FDA Drops Access Restrictions On Generic OTC Emergency Contraceptives" - HBW Insight, 5 Mar, 2014.)

HRA has made more progress on nonprescription sales of a daily oral contraceptive in the UK. The Medicines and Healthcare products Regulatory Agency recently launched a public consultation on an OTC switch of HRA’s progestogen-only Hana, 75-mcg desogestrel film-coated tablets. MHRA also is considering an OTC switch for the same formulation in Maxwellia’s Lovima. (Also see "Oral Contraceptive Rx-to-OTC Switch On The Cusp In UK" - HBW Insight, 12 Feb, 2021.)

Although no daily oral contraceptive has received the FDA’s approval, members of Congress, particularly Democrats, have pushed to extend the requirement for all private insurance plans to cover all FDA-approved methods of contraception to include full access to OTC daily oral contraceptives. (Also see "Health And Wellness On Capitol Hill: Monograph Reform, Wyden On CBD Rule, OTC Daily Contraceptive Access" - HBW Insight, 26 Jun, 2019.)