# CANLAB RESEARCH · 66-41 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For CANLAB RESEARCH · 66-41 · CANADA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CANADA; product is PT 141 Peptide; product code is 56 F - - 99 Peptide N.E.C; date published is 03/21/2020; address is 18 Saint-Viateur St W , Montreal, Quebec CANADA, verified against its source on 2026-09-16.

- **Firm:** CANLAB RESEARCH _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** CANADA _(verified: appears in the quote below)_
- **Address:** 18 Saint-Viateur St W , Montreal, Quebec CANADA _(verified: appears in the quote below)_
- **Date published:** 03/21/2020 _(verified: appears in the quote below)_
- **Product code:** 56 F - - 99 Peptide N.E.C. _(verified: appears in the quote below)_
- **Product:** PT 141 Peptide _(verified: appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug, drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is an article (other than food) intended to cure, mitigate, treat, or prevent disease in man and/or to affect the structure or function of the body. Examples of claims observed on the firm's social media website that establish the intended use of "PT-141" include, but may not be limited to, the following: On the CanLab Research Facebook social media account, on June 24, 2019, the firm posted a chromatogram report under the heading "PT-141: 98.24%." In the comments to the post, various commenters discuss how they use the product. A commenter named Joel Grotrian asked "May i (sic) ask what this means and what this peptide does?" and a commenter named Michael Shofield replied "[I]t will give you a hard-on for an entire day." Jean-Francois Tremblay, who is identified as the President of CanLab Research in the entry documents, replied to the conversation that "Often, 1 mg will do." When a commenter asked "Jean-Francois Tremblay is subQ the only way to administer or is there another option for my wife?," Jean-Francois Tremblay replied "intranasal works, but at much higher dose" and posts a link to a journal article about the use of PT-141 for erectile dysfunction. "PT-141" is also a new drug under section 201(p) of the FD&C Act, 21 U.S.C. 321(p) because this product is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in its labeling. Under section 505(a) of the FD&C Act, a new drug may not be legally marketed in the United States without an FDA-approved application. FDA approves a new drug based on scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. There is no FDA-approved application in effect for "PT-141." _(verified: appears in the quote below)_

## What the source says

> CANLAB RESEARCH Date Published : 03/21/2020 18 Saint-Viateur St W , Montreal, Quebec CANADA 56 F - - 99 Peptide N.E.C. Date Published: 03/21/2020 Desc: PT 141 Peptide Notes: The product appears to be an unapproved new drug, drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is an article (other than food) intended to cure, mitigate, treat, or prevent disease in man and/or to affect the structure or function of the body. Examples of claims observed on the firm's social media website that establish the intended use of "PT-141" include, but may not be limited to, the following: On the CanLab Research Facebook social media account, on June 24, 2019, the firm posted a chromatogram report under the heading "PT-141: 98.24%." In the comments to the post, various commenters discuss how they use the product. A commenter named Joel Grotrian asked "May i (sic) ask what this means and what this peptide does?" and a commenter named Michael Shofield replied "[I]t will give you a hard-on for an entire day." Jean-Francois Tremblay, who is identified as the President of CanLab Research in the entry documents, replied to the conversation that "Often, 1 mg will do." When a commenter asked "Jean-Francois Tremblay is subQ the only way to administer or is there another option for my wife?," Jean-Francois Tremblay replied "intranasal works, but at much higher dose" and posts a link to a journal article about the use of PT-141 for erectile dysfunction. "PT-141" is also a new drug under section 201(p) of the FD&C Act, 21 U.S.C. 321(p) because this product is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in its labeling. Under section 505(a) of the FD&C Act, a new drug may not be legally marketed in the United States without an FDA-approved application. FDA approves a new drug based on scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. There is no FDA-approved application in effect for "PT-141."

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).