WARNING LETTER
iSlim, LLC
MARCS-CMS 655819 —
May 03, 2023
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Sasha Sans
iSlim, LLC
3001 S. Ocean Dr. Apt 1639
Hollywood
,
FL
33019
United States
info@alfia.com
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
May 3, 2023
RE: 655819
Dear Mr. Shans:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.alfia.com, in December 2022, where you took orders for “Alfia Weight Loss Capsules.”
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In addition, FDA has obtained a sample and labeling of your “Alfia Weight Loss Capsules” product. As described below, 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 (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your “Alfia Weight Loss Capsules” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352 and sold in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
FDA confirmed through laboratory analysis that a sample of your “Alfia Weight Loss Capsules” 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.
Unapproved New Drug
Your “Alfia Weight Loss Capsules” product is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is intended to diagnose, cure, mitigate, treat, or prevent disease and/or affect the structure or function of the body. Examples of claims observed on your website and product label that establish the intended use of your product as a drug include, but may not limited to, the following:
On your webpage, https://alfia.com/capsules/alfia-capsules-special-offer:
Under the heading, “How ALFIA Capsules works”:
“Curb your appetite, increase your energy and help your body to burn FAT. Removes deposited fat”
Under the heading, “Mechanism of Action”:
“ALFIA helps to digest the food, hasten ALFIA helps to digest the food, hasten the fat metabolism and protect the digest[sic] organs against diseases in advance.”
Under the heading, “Loosening bowel to relieve constipation decontaminating circulation system, promoting metabolism”:
“The ingredients which include semen cassia seed can loosen [the] bowel to relieve constipation. Therefore ALFIA can effectively excrete the metabolism outcome from the body, the redundant fat which cannot be absorbed and toxin so that the bowel system can be loosened and constipation can be prevented and cured.”
On the label of your “Alfia Weight Loss Capsules” product:
“Alfia 100% NATURAL WEIGHT LOSS CAPSULES”
“LOSE 27 POUNDS in 30 DAYS”
Your “Alfia Weight Loss Capsules” is not generally recognized as safe and effective for its above referenced uses and, therefore, 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, a new drug 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). There is no FDA-approved application in effect for “Alfia Weight Loss Capsules.” Introduction or delivery of this product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
Misbranded Drug
Your “Alfia Weight Loss Capsules” product is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that its labeling fails to bear adequate directions for use. “Adequate directions for use” mean directions under which a layman can use a drug safely and for the purposes for which it is intended, 21 CFR 201.5. It is impossible to write “adequate directions for use” for “Alfia Weight Loss Capsules” 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 “Alfia Weight Loss Capsules” fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the FD&C Act. Your “Alfia Weight Loss Capsules” product is not exempt from the requirements that they bear adequate directions for use by a layperson, 21 CFR 201.100(c)(2) and 201.115, 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 “Alfia Weight Loss Capsules” 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.
“Alfia Weight Loss Capsules” is also misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because the product’s labeling lacks adequate warnings for the protection of users. As previously 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, “Alfia Weight Loss Capsules” 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. In addition to the violations discussed above, we note that you declined to conduct a voluntary recall of your “Alfia Weight Loss Capsules” 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/or injunction.
Please submit a written response to this letter within fifteen working days from the date of receipt, explaining 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 products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within fifteen working days from the date of receipt of this letter.
Please electronically submit your reply on company letterhead to Mark W. Rivero, Compliance Officer, at ORAPHARM2_RESPONSES@fda.hhs.gov. In addition, please submit a signed copy of your response to mark.rivero@fda.hhs.gov.
If you have questions regarding any issues in this letter, please contact me by e-mail at ronda.loyd-jones@fda.hhs.gov or by phone at (214) 253 - 5336, or Mr. Mark Rivero by e-mail or by phone at (954) 759 - 7718.
Sincerely,
/S/
Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
Division II
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1
FDA issued a warning to consumers not to use your “Alfia Weight Loss Capsules” (see Alfia Weight Loss Capsules contain hidden drug ingredient:
https://www.fda.gov/drugs/medication-health-fraud/public-notification-alfia-weightloss-capsules-contain-hidden-drug-ingredient
). Further, we acknowledge that you no longer offer this product for sale on your website at http://www.alfia.com/.
Content current as of:
05/16/2023
Regulated Product(s)
Drugs