Reference Source

CANLAB RESEARCH · 66-41 · CANADA

For CANLAB RESEARCH, import alert is 66-41; country is CANADA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 2026-10-01.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

CANLAB RESEARCH Date Published : 03/21/2020 18 Saint-Viateur St W , Montreal, Quebec CANADA

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

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."

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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