WARNING LETTER
PureRawz
MARCS-CMS 715218 —
September 08, 2025
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Seann Gloss
PureRawz
1404 Lakeshire Dr.
Knoxville
,
TN
37922
United States
support@purerawz.co
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
September 8, 2025
RE: 715218
Dear Seann Gloss:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://purerawz.co in August 2025 and has observed that your website offers products for sale in the United States (U.S.), including the following: “Tianeptine Ethyl Ester Sulfate,” “Tianeptine Free-Acid,” “Tianeptine Sodium,” “Tianeptine Sulfate,” and “Tianeptine Ultimate” (hereinafter your Tianeptine products). We have also reviewed your social media accounts at www.facebook.com/purerawz/ and www.instagram.com/purerawzrevolution/. Your social media accounts direct consumers to your https://purerawz.co website to purchase your products. Based on our review, your Tianeptine products are unapproved new drugs introduced or delivered for introduction into interstate commerce 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), as described below.
Furthermore, FDA has warned consumers about products containing tianeptine, which is used as a prescription drug in some European, Asian, and Latin American countries but is not an FDA-approved drug in the U.S. The FDA is aware of several serious adverse event reports associated with tianeptine and that consumers may find themselves addicted to tianeptine.
1
Despite statements on your product labeling marketing your products “for laboratory and research use only,” evidence obtained from your websites establish that your products are intended to be drugs for human use. Based on our review of your labeling, your Tianeptine products 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 to prevent, treat, mitigate, or cure disease conditions and/or affect the structure or any function of the body. Examples from your product labeling, including on your website and social media accounts that provide evidence of the intended use (as defined in 21 CFR 201.128) of your products as drugs for human use include, but may not be limited to, the following:
On your webpages https://purerawz.co/product/tianeptine-ethyl-ester-sulfate/ and https://purerawz.co/product/tianeptine-free-acid/:
“Tianeptine is a compound used primarily in research as a method to treat major depressive disorder[].”
On your webpages https://purerawz.co/product/tianeptine-ethyl-ester-sulfate/ and https://purerawz.co/product/tianeptine-ultimate/:
“Tianeptine is also currently being investigated for its efficacy in treating depression in Parkinson’s disease and in post-traumatic stress disorder, as well as asthma and irritable bowel syndrome.”
On your “Tianeptine Sodium” webpage https://purerawz.co/product/tianeptine-sodium/:
“Tianeptine Sodium is a unique tricyclic compound known for its antidepressant and anxiolytic properties. Tianeptine sodium exhibits a distinct mechanism of action, making it an excellent option for patients with depressive disorders, particularly those who have not responded to conventional treatments.”
“Tianeptine Sodium is used to treat major depressive disorder (MDD), anxiety disorders, and sometimes for the management of irritable bowel syndrome (IBS). It is also explored for its neuroprotective and cognitive-enhancing effects.”
“Potential Benefits[:] Potentially Effective in Treating Depression[,] Reduces Anxiety Symptoms[,] Enhances Cognitive Function[,] Neuroprotective Properties[, and] Minimal Sexual Dysfunction.”
On your “Tianeptine Ultimate” webpage https://purerawz.co/product/tianeptine-ultimate/:
“As an antidepressant tianeptine is similar to amitriptyline, imipramine, and fluoxetine, tianeptine exhibits efficacy against major depressive episodes, but with much fewer adverse effects.”
“Asthma patients and respiratory depression have shown great success with tianeptine.”
“In addition to its analgesic and anticonvulsant properties, tianeptine also has anticonvulsant properties.”
“The effectiveness of tianeptine in the treatment of attention-deficit hyperactivity disorder has been demonstrated, and its adverse effects are kept to a minimum.”
On your “Tianeptine Restrictions” webpage https://purerawz.co/tianeptine-restrictions/:
“Tianeptine is a unique yet controversial compound that has garnered the intention of researchers worldwide. Initially developed in the 1980s as a treatment for depression, Tianeptine is currently classified as an atypical tricyclic antidepressant. Research shows it works by modifying the glutamatergic system by controlling AMPA and NMDA receptors. This unique mode of action allows Tianeptine to improve serotonin reuptake in specific brain areas. This is in contrast to conventional antidepressants that raise serotonin levels.”
On your Instagram and Facebook social media accounts at www.instagram.com/purerawzrevolution/ and www.facebook.com/purerawz/:
March 12, 2025 post: “Break the chaos. Find clarity . . . Unleash the untapped potential of Tianeptine Sodium—a powerhouse for emotional balance, razor-sharp mental clarity, and relentless stress relief.”
Additionally, your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the treatment of disease and/or to affect the structure or function of the body. Examples of such testimonials include, but are not limited to, the following:
“I suffer from depression and this has helped me so much to feel more positive and optimistic.” [From the Reviews section of the “Tianeptine Ethyl Ester Sulfate” product webpage https://purerawz.co/product/tianeptine-ethyl-ester-sulfate/]
“This helped stabilize my mood and allow my overall mental health instantaneously.” [From the Reviews section of the “Tianeptine Free-Acid” product webpage https://purerawz.co/product/tianeptine-free-acid/]
“My anxiety has taken a back seat, and I’m feeling more motivated and focused than ever.” [From the Reviews section of the “Tianeptine Sodium” product webpage https://purerawz.co/product/tianeptine-sodium/]
“I love this product[.] I have intrusive thoughts and sensations of fear that cause anxiety/panic. I take 2 of these and within 15 mins my body sensations disappear and my mind is quiet.” [From the Reviews section of the “Tianeptine Sulfate” product webpage https://purerawz.co/product/tianeptine-sulfate/]
“I have used this Tianeptine Ultimate for many months due to depression and anxiety. This product does help a lot and takes the edge off enough to calm me.” [From the Reviews section of the “Tianeptine Ultimate” product webpage https://purerawz.co/product/tianeptine-ultimate/]
Moreover, your Tianeptine products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the above-described conditions prescribed, recommended, or suggested in their labeling. Subject to certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates 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 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 fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
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 “715218” 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
U.S. Food and Drug Administration
_____________________
1
See https://www.fda.gov/consumers/consumer-updates/tianeptine-products-linked-serious-harm-overdoses-death.
Content current as of:
09/23/2025
Regulated Product(s)
Drugs