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  1. Warning Letters

WARNING LETTER

Amazon.com, Inc. MARCS-CMS 695821 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Andy Jassy
Recipient Title
CEO
Amazon.com, Inc.

410 Terry Ave. N
Seattle, WA 98109-5210
United States

Regulatory-inquiries@amazon.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

March 3, 2025

RE: 695821

Dear Mr. Jassy:

This letter concerns your firm’s distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). The United States Food and Drug Administration (FDA) reviewed injectable lipolytic drug products that were purchased on your website, www.amazon.com. As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs 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, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

FDA purchased “LemonBottle Ampoule Solution,” “L-Carnitine Body Serum Ampoule,” and “Matrigen PPC Ampoule” through your website, www.amazon.com. These products, which are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.1

These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.

Unapproved New Drugs

“LemonBottle Ampoule Solution,” “L-Carnitine Body Serum Ampoule,” and “Matrigen PPC Ampoule” are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

Examples of claims observed on the labeling that establish the intended use of these products as drugs include, but may not be limited to, the following:

LemonBottle Ampoule Solution
The QR code sticker on the product package directs to the URL website, https://makesolutions.kr/?A=453691044904, which includes a link to the website, www.lemonbottle.net, which redirects consumers to the website, www.sidmedicos.com.

From www.sidemedicos.com:
􀁸 “LEMONBOTTLE LIPOLYSIS”
􀁸 “How LEMONBOTTLE Treatment works and why it is safety [sic] . . . how
LEMON BOTTLE DISSOLVES fat . . .Riboflavin in LEMONBOTTLE helps discharge dissolved fat from our body faster than normal metabolism speed. . . . Lecithin breaks down first cell fat membrane.”

The website, www.sidmedicos.com, includes a link to the social media website for “Lemonbottleofficial,” www.instagram.com/lemonbottle_official, which includes the following:
􀁸 January 4, 2023 post: “NEW GAME CHANGER to lipolysis”
􀁸 October 15, 2024 post: “HEALTHY FAT LOSS TIPS You Need!”
“LEMONBOTTLE for Stubborn fat.”
􀁸 July 30, 2024 post: “Target stubborn fat that exercise and diet alone can’t seem to eliminate . . . Struggling with stubborn fat that just won’t budge despite your best efforts? Discover a non-surgical alternative to liposuction that effectively targets and eliminates unwanted fat, giving you the body confidence you’ve been striving for . . . #lemonbottlefatdissolving.”
􀁸 July 18, 2024 post: “Are you bothered by belly fat that folds when you sit? Have your favorite pants suddenly become too snug? Trust LemonBottle to solve your stubborn fat concerns.”

L-Carnitine Body Serum Ampoule
From the product label
􀁸 “lipolytic solution”

Matrigen PPC Ampoule
From product label
􀁸 “Scientific lipolysis effects for balanced body line
By applying PPC Ampoule into the fat tissues, it separates and destroys connection among fat cells around applied areas and decomposes fat. The decomposed fat is removed through body’s venous system and lymph system, because by this way PPC destroys applied area’s fat permanently, the treatment is also called ‘non-incision permanent fat removal treatment.”

􀁸 “PPC Ampoule Mechanism Diagram” accompanied by images of what appears to be the human abdominal area that reduces in size along with each the following stated steps:
o “STEP 1 – Fat cells necessary to be treated on the body parts”
o “STEP 2 – Apply PPC Ampoule and be delivered into targeted area”
o “STEP 3 – Fat cells then separate and harden”
o “STEP 4 – Harden fat cells break out and are excreted through the body”

“LemonBottle Ampoule Solution,” “L-Carnitine Body Serum Ampoule,” and “Matrigen PPC Ampoule” are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. 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, including steps you will take to ensure that Amazon will no longer introduce, or deliver for introduction into interstate commerce unapproved injectable lipolytic drug products, as well as copies of related documentation. If you believe that the products you distribute 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.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 695821” in the subject line of the email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

_________________

1 Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products discussed below was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a program that lets you outsource order fulfillment to Amazon and offer customers free, two-day shipping through Prime. By enrolling in FBA, you can send your products into Amazon’s global network of fulfillment centers, and we’ll pick, pack, and ship orders, as well as handle customer service and returns. FBA is part of a fully automated set of services we call Supply Chain by Amazon.” (See https://sell.amazon.com/fulfillment-by-amazon).

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