WARNING LETTER
Je Dois Lavoir LLC
MARCS-CMS 616016 —
August 11, 2021
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Sandra Orozco
Recipient Title
CEO
Je Dois Lavoir LLC
(b)(6)
United States
cs@jedoisavoir2020.com
sorozco30@icloud.com
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
WARNING LETTER
August 11, 2021
Dear Ms. Orozco:
This letter is to advise you that the United States Food and Drug Administration has reviewed your website at https://jedoisavoir2020.com in June 2021 and has determined that you take orders there for “365 Skinny High Intensity.” We have also reviewed your social media websites at www.facebook.com/jdl2020 and www.instagram.com/j_d_l2020; these social media websites direct consumers to your website https://jedoisavoir2020.com to purchase your products. The claims on your website and social media websites establish that your “365 Skinny High Intensity” product is intended for weight loss. Therefore, this product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d), and a misbranded drug sold in violation of sections 502 and 301(a) of the FD&C Act, 21 U.S.C. 502 and 331(a). You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
FDA confirmed through laboratory analysis that a sample of your “365 Skinny High Intensity” contains undeclared sibutramine. Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.
FDA has issued a warning to consumers not to use “365 Skinny High Intensity” (see 365 Skinny High Intensity Immediate Public Notification).
Unapproved New Drug
You market “365 Skinny High Intensity” as a dietary supplement. However, under section 201(ff)(3)(B)(ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(ii), a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before it was authorized for investigation as a new drug.
The investigational new drug (IND) application for Meridia (sibutramine) was received by FDA on December 24, 1985, and sibutramine became authorized for investigation as a new drug under an IND on January 23, 1986. When Meridia was approved for marketing as a new drug in the United States, the existence of substantial completed clinical investigations of sibutramine became public. Based on the information available to FDA, sibutramine was not marketed as a dietary supplement or as a food until after it was authorized for investigation as a new drug. Therefore, “365 Skinny High Intensity,” which contains sibutramine, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act.
Your “365 Skinny High Intensity,” is an article intended to diagnose, cure, mitigate, treat, or prevent disease and/or an article (other than food) intended to affect the structure or function of the body and, thus, is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1). Some examples of claims observed on your website and social media websites that establish the intended use of your product as a drug include, but may not limited to, the following:
On your website https://jedoisavoir2020.com
• “365 Skinny High Intensity new silver label Strong Formula 2020 are [sic] giving excellent results in the loss of weight with a single capsule a day!”
On your website https://jedoisavoir2020.com and Facebook Account, www.facebook.com/jdl2020, October 19, 2020 Post
• “It is a totally natural herbal supplement for anti obesity that controls anxiety, inhibits appetite, burns fat, high cholesterol, helps with sugar levels, accelerates metabolism, eliminates toxins, reduce swelling and increase your energy.”
• “How does this capsule work? . . . Appetite Control . . . Accelerates metabolism . . . Increase your energy . . . Causes satiety . . . Burn fat through the urine . . . Eliminates toxins in the skin . . . Regenerates muscle mass . . . Reduces fat deposits and cellulite . . . Increases libido . . . Balances insulin and blood sugar levels”
• “Bitter orange extract: reduces ‘bad’ cholesterol prevents digestive disorders and regulates bowel movement” [sic]
• “Cassia seed: combat constipation”
• “Alism: eliminates fluid retention, reduces appetite”
Your “365 Skinny High Intensity” product is not generally recognized as safe and effective for its above referenced uses and, therefore it 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 prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There is no FDA-approved application in effect for your product.
Misbranded Drug
Your “365 Skinny High Intensity” product is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that the labeling for this drug fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5). It is impossible to write “adequate directions for use” for “365 Skinny High Intensity” for at least two reasons: 1) prior to withdrawal of Meridia’s approval, FDA approval of sibutramine was limited to use under the professional supervision of a practitioner licensed by law to administer such drugs and 2) FDA approval of Meridia was withdrawn because of serious safety risks. As such, the labeling of “365 Skinny High Intensity” fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the FD&C Act. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your “365 Skinny High Intensity” product is not exempt from the requirement that its labeling bears adequate directions for use because no FDA-approved application is in effect for this product.
Additionally, under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n) provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations . . ..” Your “365 Skinny High Intensity” product is misbranded under section 502(a) of the FD&C Act because the labeling fails to reveal the sibutramine content, which is a material fact with respect to consequences that may result from the use of this product. As described above, sibutramine may pose health risks to consumers which are only compounded by the fact that the ingredient is not declared on the label.
“365 Skinny High Intensity” is also misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because the product labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of this product, particularly since someone who takes it would be unaware of the presence of the undeclared ingredients.
Likewise, “365 Skinny High Intensity” is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is dangerous to health when used in the dosage or manner recommended in the labeling. As previously noted, sibutramine poses an increased risk of heart attack and stroke.
The introduction or delivery for introduction into interstate commerce of this misbranded drug product is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
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/or injunction.
We acknowledge that your firm voluntarily recalled 365 Skinny High Intensity and 365 Skinny Emergency Boutique products on August 2, 2021. You also market other products on your website https://jedoisavoir2020.com, including foods, dietary supplements, and topicals. While FDA has not tested these products marketed by your firm, you are responsible for ensuring that they do not contain undeclared ingredients.
A full list of all tainted products discovered by FDA can be found at
http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder
.
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 cannot complete corrective actions within fifteen 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 FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should refer to unique identifier CMS 616016 and be sent electronically to ORAPHARM4_Responses@fda.hhs.gov or mailed to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food and Drug Administration
19701 Fairchild Road
Irvine, CA 92612
If you have any questions regarding this letter, please contact Jamie Dion, Compliance Officer, at 303-236-3133 or by email at Jamie.Dion@fda.hhs.gov.
Sincerely,
/S/
Lance M. De Souza
Acting Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
08/24/2021
Regulated Product(s)
Drugs