Marketer Of Glycerin, Oleate OTC Contraceptive Cream Consents To Ending Production, Sales

An Arizona company agreed to stop making and marketing a topical labeled as a vaginal cream after previously saying its commitment to continue selling the product as a contraceptive was “unalterable.”

The US Department of Justice, litigating a complaint for the Food and Drug Administration, on 15 November announced that Smart Women’s Choice Inc. agreed to a consent decree requiring the firm to halt production and sales of its namesake brand product promoted as being hormone-free and with claims including “immobilizing sperm” and “preventing fertilization.”

A company with a history linked to Smart Women’s Choice and also warned by the FDA, however, continues to offer its own contraceptive cream with a similar formulation and claims (see box below).

Smart Women’s Choice, which was launched in 2014 in California before being acquired in 2021 and moved to El Mirage, AZ, by current owner Jennifer Richard, agreed to requirements including hiring a consultant to guide remediation to reach complete regulatory compliance should it intend to resume making and selling its product formulated with water, glycerin, potassium oleate, palmate, castorate, citrate and mono- and di-glycerides.

Should the company resume operations, audit inspections by an expert confirmed by the FDA would be required at least once every six months for five years.

Compliance with FDA labeling regulations, supervised by a “labeling expert,” to prevent the firm’s formulations from being deemed unapproved drugs is prominent in the remediation requirements detailed in the decree entered on 14 November in US District Court for Arizona and approved by Chief Judge Murray Snow.

“The FDA remains fully committed to taking enforcement action against companies and executives responsible for marketing unapproved drugs in violation of federal law,” said Jill Furman, compliance director in the FDA’s Center for Drug Evaluation and Research, in the DoJ announcement.

The settlement also states that in the event Smart Women’s Choice fails to comply with any requirement stated in the decree or in FDA regulations, it must pay $1,000 in damages for each day a violation continues, an additional $1,000 for each product or act in violation and “further additional sum equal to the retail value of drugs that have been manufactured, prepared, processed, packed, repacked, received, labeled, held, and/or distributed in violation."

The document states that Richard and the firm “understand and agree that the liquidated damages specified … are not punitive in nature and their imposition does not in any way limit the ability of the United States to seek, or the Court to impose, civil or criminal penalties … or remedies based on conduct that may also be the basis for payment of liquidated damages pursuant.”

Additionally, if the DoJ seeks and gains a contempt order to enforce the terms, Richard and the firm “shall, in addition to other remedies, reimburse the United States for its attorneys’ fees (including overhead), investigational and analytical expenses, expert witness fees, and any other court costs or fees.”

The complaint filed in October stated that as of mid-July, the firm maintained Facebook and Instagram pages featuring links to its website and where customers could obtain information about its product.

Smart Women’s Choice’s website remained live but showed no content on 15 November; the phone number listed with the company’s Arizona business registration has been disconnected.

‘Market Tested’ Isn’t GRASE

The company responded in May 2021 to an FDA warning letter, submitted the same month to the firm’s former California address, disputing that the Smart Women’s Choice is a “drug” under FDA regulations and stating that the “product is market tested” and has been sold “for over seven years to many thousands of couples,” according to the complaint. (Also see "Ruining The Mood, US FDA Says Glycerin, Oleate Cream Not Approved As OTC Contraceptive" - HBW Insight, 25 May, 2021.)

The agency the following month further explained its policy in an email to the company. FDA officials said “immobilizing sperm,” “preventing fertilization” and other claims on the company’s website and social media pages rendered its product a drug under FDA regulations codified in 21 USC Sec. 321(k).

The officials also explained that the company’s claims regarding consumer testing does not demonstrate safety and efficacy because the agency, under 21 USC Sec. 331(d) and Sec. 355(a)(b) and (j), approves new drugs on the basis of scientific data and information demonstrating a drug is safe and effective for its intended uses.

However, Smart Women’s Choice replied the same day saying it intended to continue selling the product without FDA approval, according to the complaint.

And when the FDA in November 2021 requested a meeting to discuss the continued violations, Smart Women’s Choice company responded a month later by refusing to meet with the agency, “stating that the company’s position was “unalterable’.”

“FDA has conducted a comprehensive search of the publicly-available scientific and medical literature for [the Smart Women’s Choice] product and determined there are no published adequate and well-controlled clinical investigations or any other scientific literature demonstrating [the product is generally regarding as safe and effective] for its intended use as a contraceptive,” DoJ’s Consumer Protection Branch attorneys wrote in the complaint.

They added that “qualified experts cannot come to a consensus [the product] is safe and effective for its intended use.

The attorneys, working with the FDA Office of General Counsel, also wrote in the complaint that “despite FDA’s repeated notifications, Defendants have demonstrated their unwillingness to comply with” FDA regulations and would continue “unless restrained by order of this Court.”

OTC Contraceptive Approved
Since Smart Women's Warning

Although the FDA regularly warns firms that dietary supplement products, and less often food and topical products, are unapproved drugs because they’re marketed with claims for preventing or treating diseases and other health conditions, a lotion available OTC and marketed with claims as a contraceptive was a rare find for the FDA.

No daily oral contraceptive had been approved for OTC sales in the US when the FDA warned Smart Women’s Choice. Since then, the agency approved Perrigo Company PLC business HRA Pharma’s supplemental new drug application for a full Rx-to-OTC switch of 0.075-mg norgestrel branded Opill and for sales without age restrictions. (Also see "First OTC Birth Control Pill Approved In US Will Launch With Three-Year Market Exclusivity" - HBW Insight, 13 Jul, 2023.)

The approval in July 2023 came 60 years after Rx birth control's initial approval in the US and one year after both HRA submitted the sNDA and the Supreme Court decided in Dobbs v. Jackson (Mississippi) Women’s Health Organization to allow states to regulate access to abortion services. (Also see "Allowing States To Ban Abortion Services Increases Calls For Making Birth Control Available OTC" - HBW Insight, 24 Jun, 2022.)

Additionally, President Biden weeks earlier had issued an executive order on expanding access to birth control in the US including OTC access to oral contraceptives. The executive order was the Biden administration’s third on reproductive health care access since the Supreme Court’s Dobbs decision. (Also see "Biden Calls For Expanding Access To Reproductive Health Care, Including OTC Oral Contraceptives" - HBW Insight, 23 Jun, 2023.)

Perrigo plans to launch Opill sales in the 2024 first quarter.