WARNING LETTER
LeRoche Benicoeur dba ConceiveEasy
MARCS-CMS 613647 —
May 20, 2021
Product:
Drugs
Recipient:
Recipient Name
Mary Whittaker
LeRoche Benicoeur dba ConceiveEasy
1130 Fremont Blvd #301
Seaside
,
CA
93955
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Federal Trade Commission
WARNING LETTER
May 20, 2021
RE: 613647
Dear Mary Whittaker:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address, www.conceiveeasy.com, in March 2021 and has determined that you take orders there for the product “ConceiveEasy.” You are also advised that the Federal Trade Commission reviewed your website in May 2021.
The claims on your website and social media webpages establish that your product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include the following:
On the Homepage:
• “Who Does ConceiveEasy Work For? ...
o “Women with luteal phase defect”
o “Women with PCOS – Polycystic Ovary Syndrome… the single most common cause of infertility inwomen”
o “Women using IVF…boost your chances from the start”
o “Women taking Clomid – Give Clomid a boost”
On the “Ingredients” page [each ingredient below is represented to be present in the product “ConceiveEasy”]:
• “Sabina is used to help treat infertility for its effectiveness in preventingrecurrent miscarriages during early stage pregnancy.”
• “Apis mellifica is most widely used ... in the treatment of ovarian inflammation and ovarian cysts.”
• “Viburnum opulus is used … for preventingmiscarriages”
• “Glycyrrhiza uralensis is … used to treat Polycystic Ovarian Syndrome for its abilities to help normalize adrenal function and reduce testosterone levels.”
On the “Fertibella ConceiveEasy Pills for Women” page:
• “[ConceiveEasy] does not treat only one cause of infertility, but tackles them all simultaneously: it regulates menstrual and ovulatory disorders; it helps eliminate luteal phase defects…”
On the “Pills to Get Pregnant: The Ultimate Guide” page:
• “Not only has Vitex [an ingredient in the “ConceiveEasy” product, also known as “agnus castus”] been proven to help treat mild endometriosis, it can also keep cases of endometriosis from advancing and becoming worse. …Vitex ... can help to reduce the size of uterine cysts. This can be incredibly helpful for fertility, since many women with uterine cysts have a hard time getting pregnant. … Vitex … can help to prevent miscarriage in women who are at risk of miscarriage due to low progesterone levels. … In a study of women who had absent periods (also known as amenorrhea), more than 70 percent of the women had actually resumed their menstrual periods after using Vitex for six months.”
• “White Peony [an ingredient in the “ConceiveEasy” product, also known as “paeonia alba”] is another very popular fertility herb, ... has traditionally been used for ... treatment of PCOS, uterine fibriods [sic] and also for endometriosis.”
• “This supplement [“ConceiveEasy”] is designed to help combat all of the problems that many women face when trying to conceive, including PCOS, endometriosis, ovulation problems, irregular menstrual periods and much more.”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “ConceiveEasy” for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include the following:
On the “REVIEWS” page:
• “Katherine: We couldn’t afford the expensive fertility drugs and fertility treatments..after taking the TTC Kit pill for 2 ½ months… I am pregnant.
Your product “ConceiveEasy” is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the 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 prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your product “ConceiveEasy” is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, “ConceiveEasy” fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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.
Please notify FDA in writing, within 15 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 cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Aaron Dotson, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, you may also contact Aaron Dotson at aaron.dotson@fda.hhs.gov.
In addition, the Federal Trade Commission has determined that it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess a reasonable basis consisting of competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.
POM Wonderful LLC
, 155 F.T.C. 1, 60-61, (2013),
aff’d in relevant part
, 777 F.3d 478 (D.C. Cir. 2015);
Daniel Chapter One
, FTC Dkt. No. 9239, 2009 WL 5160000 at *16-19 (F.T.C. Dec. 24, 2009),
aff’d
, 405 Fed. Appx. 505 (D.C. Cir. 2010);
Removatron Int'l Corp
., 111 F.T.C. 206, 297-99 (1988),
aff’d
, 884 F.2d 1489, 1496 (1st Cir. 1989); see also, FTC v.
Direct Mktg. Concepts
, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008),
aff’d
, 624 F.3d 1 (1st Cir. 2010); FTC v.
Nat'l Urological Group, Inc
., 645 F. Supp. 2d 1167, 1190, 1202 (N.D. Ga. 2008),
aff’d
, 356 Fed. Appx. 358 (11th Cir. 2009);
FTC v.
Natural Solution, Inc
., No. CV 06-6112-JFW, 2007-2 Trade Cas. (CCH) P75,866, 2007 U.S. Dist. LEXIS 60783, at *11-12 (C.D. Cal. Aug. 7, 2007). More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act.
See Daniel Chapter One
, WL 5160000 at *17-19.
The FTC is concerned that one or more of the efficacy claims cited above may not be substantiated by competent and reliable scientific evidence. The FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and
reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. In addition, marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of a
disease may be subject to a civil penalty of up to $43,792 per violation pursuant to Section 5(m)(1)(B) of the FTC Act, 15 U.S.C. § 45(m)(1)(B), and may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b).
With regard to the advertising claims discussed above, please notify Richard Cleland of the FTC via electronic mail at rcleland@ftc.govwithin fifteen (15) working days of receipt of this letter, of the specific actions you have taken to address FTC's concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088.
Sincerely,
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Sincerely,
/S/
Serena Viswanathan
Associate Director
Division of Advertising Practices
Federal Trade Commission
Content current as of:
05/26/2021
Regulated Product(s)
Drugs