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WARNING LETTER

Wise Women’s Choice MARCS-CMS 658897 —


Delivery Method:
Via Email
Product:
Drugs

Recipient:
Recipient Name
Lauren Love
Recipient Title
CEO
Wise Women’s Choice

284 Saddlebrook Dr.
San Antonio, TX 78245
United States

wisewomenschoice@gmail.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

July 20, 2023

RE: 658897

Dear Lauren Love:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed the labeling of your product, “Wise Women’s Choice,” as of May 2023, including your website at https://wisebirthcontrol.com and your social media website at https://www.facebook.com/groups/866378871284055, where you direct consumers to your website to purchase your product. The FDA has observed that your website offers your product for sale in the United States. Based on our review, your product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a). As explained further below, the introduction or delivery for introduction into interstate commerce of your unapproved new drug violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Unapproved New Drug Product

Based on our review of your website and social media website, your product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article other than food intended to affect the structure or any function of the human body.

Examples of claims observed on your product’s labeling, including the website https://wisebirthcontrol.com, and your social media website https://www.facebook.com/groups/866378871284055, that provide evidence that this product is intended to affect the structure or function of the human body include the following:

From the labeling included in your product packaging:

  • “Natural Birth Control Cream”
  • “Wise Women’s Choice works entirely differently from all other contraceptives; it immobilizes sperm (video #2) on our website . . . on contact, in the vagina, where it is deposited during intercourse. Being immobilized, it cannot travel into the Fallopian tubes, where fertilization occurs. NO FERTILAZATION = NO PREGNANCY”

From your website at https://wisebirthcontrol.com:

  • “There exists a natural birth control cream that’s effective and safe[,] Wise Women’s Choice, formerly known as Smart Women’s Choice contraceptive cream is 99.8% effective.”
  • “How does it work[,] Wise birth control works by simply immobilizing the sperm, if it can’t get to the egg. Thus preventing fertilization.”
  • “Wise is 99.8% effective. This is just as, or more effective than every synthetic birth control on the market today.”
  • “WISE works by an entirely different mechanism than other birth controls: it immobilizes the sperm in the vagina; therefore the sperm cannot make the journey to the fallopian tubes from the vagina, where it is deposited during intercourse. The fallopian tubes are the only place where an egg can get fertilized. No fertilization means no pregnancy.”
  • “WISE is intended to prevent unwanted pregnancies.”

From your website at https://wisebirthcontrol.com/qustions/:

  • “Q: WHAT IS WISE Women’s Choice? WISE is a vaginal cream, the ONLY hormone-free, completely safe birth control contraceptive available.”
  • “HOW IS WISE DIFFERENT FROM OTHER CONTRACEPTIVES? WISE is unique; it works by immobilizing the sperm in the vagina. Immobilized sperm cannot make the journey into the Fallopian tubes, the only place where an egg can get fertilized. Without fertilization, it is impossible to get pregnant . . . It merely coagulates the sperm and prevents it from meeting the ovum/egg."
  • “DOES WISE NEED OTHER FORMS OF BIRTH CONTROL PAIRED WITH IT? No, WISE works independently to prevent unwanted pregnancies . . ..”
  • “HOW EFFECTIVE IS WISE? WISE is 99.8% effective. Out of every 1000 containers sold, 2 women report becoming pregnant while using WISE.”

From a January 1, 2023 post on your Facebook page at https://www.facebook.com/groups/866378871284055:

  • “Meet Wise Women’s Choice . . . The natural birth control cream that simply stops the sperm so it can’t swim to meet the egg. Simple brilliance, making pregnancy impossible. Check out the website to learn more for yourself and get hooked up with the easiest, most natural birth control around. www.wisebirthcontrol.com”

From December 31, 2022 posts on your Facebook page at https://www.facebook.com/groups/866378871284055:

  • “We have now available a natural birth control cream that works by simply immobilizing the sperm. It’s that simple. A pea sized amount in the vagina before penetration, and the sperm is stopped in it’s [sic] tracks, making it impossible to reach and fertilize the egg. It’s so simple. And so effective. As in over 20,000 women have used it with no reported pregnancies to date. Check it out for yourself. www.wisebirthcontrol.com”
  • “Wise Women’s Choice is a natural birth control cream, made of 100% pure plant extracts, that is 99.8% effective with no harmful side effects. Join the revolution www.wisewomenschoice.com”

Your product is not generally recognized as safe and effective (GRASE) for the uses in its labeling referenced above and, therefore, this product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an FDA-approved application in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application under section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your product. Accordingly, your introduction or delivery for introduction into interstate commerce of your product is a prohibited act under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Additionally, we note that the FDA previously issued a warning letter, enclosed, to Dr. Francoise Farron of Smart Women’s Choice on May 19, 2021, concerning a product called “Smart Women’s Choice” with contraceptive claims in its labeling that are similar to those in the labeling of your product. FDA’s warning letter advised Dr. Farron that the introduction or delivery for introduction into interstate commerce of her unapproved new drug violated sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). We have observed that your website states that you market your product with Dr. Farron’s “permission[,] … support and backing.”

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Please direct any inquiries to FDA at FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/
CAPT Tina Smith
Acting Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

 
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