CANLAB RESEARCH · 66-41 · CANADA
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
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- CANADA verified
- Address
- 18 Saint-Viateur St W , Montreal, Quebec CANADA verified
- Date published
- 03/21/2020 verified
- Product code
- 56 F - - 99 Peptide N.E.C. verified
- Product
- PT 141 Peptide verified
- 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
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."
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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