“In the U.S., we have regulations for food, for dietary supplements and for drugs, and this category of ‘research chemicals’ sits outside of that, as developing new substances without a regulatory home,” said Catlin, president of BSCG. “And that’s really what concerned me about the category and wanted to explore it a little further and see what was really going on here.”
While FDA-approved GLP-1 drugs have legitimized peptide interest, underground research chemicals operate in a regulatory gray area where pharmaceutical companies cannot legally sell unapproved drugs, yet the research chemical industry can.
“Research chemicals and research peptides in particular have come on the scene really strong in the last five years or so,” said Catlin. “They are substances that are created to be drugs in one way, shape, or form or another, but haven’t yet gone through any of the typical approval pathways, clinical trials, and so forth to demonstrate efficacy and safety. You literally have a marketplace growing for what are called ‘research chemicals’ or ‘unapproved peptides’, [which are] unapproved drugs in general. And those are starting to appear next to dietary supplements. Sometimes they’re appearing in dietary supplement packages or as substances available for subcutaneous injection.”
Catlin noted that because these types of peptides sit outside of any regulated categories, there is no expectation for good manufacturing practices (GMP) to apply to the category.
“So it’s really a choose-your-own-adventure. It’s up to the chemical companies that are making these things to figure out quality control, good manufacturing practices, testing for C of As, verifying that there’s no contaminants, heavy metals, pesticides, whatever. It’s anybody’s guess what’s really happening with the quality control of these unregulated peptides,” he said.
Catlin said his December 3 article with the Associated Press has had a significant impact on the sale of research peptides, noting that hundreds of listings on Alibaba, Amazon and Walmart are no longer active.
In response to the new findings, Amazon told the AP that it requires all available products to comply with applicable laws and regulations. The tech giant added that violation of its policies will lead to removal of products. “Although some of these substances may not be legally restricted in ordinary consumer contexts, we have proactively adopted stricter standards to define operational boundaries and our compliance efforts go beyond passive adherence and minimum legal requirements,” the company said in a statement to the AP.
Alibaba told the AP: “Although some of these substances may not be legally restricted in ordinary consumer contexts, we have proactively adopted stricter standards to define operational boundaries and our compliance efforts go beyond passive adherence and minimum legal requirements.”
This is not a new issue, however, with an investigation by The Markup in 2020 reporting similar issues. At the time, a spokesperson for Amazon told The Markup that such listings were “allowed in our store for laboratory or research use only and not for human injection or consumption… We do not sanction customer misuse or abuse of products. However, out of an abundance of caution, we decided to no longer allow these products and have been removing them since, as we have in this case.” In addition, a 2023 paper published in Performance Enhancement & Health found the availability of novel synthetic peptide hormones for UK consumers via Amazon UK, eBay, and Alibaba.
To hear more on what Catlin says needs to be done from a consumer safety and regulatory standpoint, listen to the NutraCast above or on your preferred podcast platform.
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