On Oct. 13, 2023, Mike O’Hearn brought the owner of Titan Medical — a hormone replacement therapy clinic based in Tampa, FL — John Tsikouris, on The Mike O’Hearn Show to review the sudden shift the Federal Drug Administration (FDA) made on peptides to a Schedule II substance — the same category as “fentanyl, hydromorphone, meperidine, methadone, morphine, oxycodone, dextroamphetamine, methylphenidate, methamphetamine, pentobarbital, and secobarbital.” (1)
In the video below, published on Generation Iron‘s YouTube channel, the duo discusses peptides, including what they’re used for and what the shift to a Schedule II drug means as a substance group.
Editor’s note: The content on BarBend is meant to be informative in nature, but it should not be taken as medical advice. The opinions and articles on this site are not intended for use as diagnosis, prevention, and/or treatment of health problems. Talking to your doctor before beginning a new fitness, nutritional, and/or supplement routine is always a good idea.
What Are Peptides?
According to John Tsikouris, peptides aren’t narcotics or controlled substances. He considers them helpful groupings of amino acids one can receive exogenously to improve health and well-being. For reference, peptides are short strings of two to 50 amino acids joined via a covalent bond. Peptide chains are the building blocks of proteins that can affect muscle growth, wound healing, sexual performance, testosterone, fertility, and more. (2)
FDA’s Substance Schedule Ratings
The Controlled Substance Act was passed in the USA in 1970 as part of the Comprehensive Drug Abuse Prevention and Control Act. It established five drug schedules to classify substances. The rating classes regulate who is able to prescribe the substances in each class via licenses distributed by the Drug Enforcement Administration (DEA). Schedule I includes substances that offer the most potential for addiction and use disorder, while Schedule V has the least.
Schedule I
Per StatPearls, Schedule I substances include “heroin, lysergic acid diethylamide, mescaline, methylenedioxymethamphetamine (MDMA), and methaqualone,” and marijuana in some states at the time of this article’s publication.
Schedule II
Schedule II are substances that are “typically prescribed to treat severe pain, anxiety, insomnia, and ADHD.” Schedule II substances include SARMs (selective androgen receptor modulators), which can cause adverse side effects like mood swings, acne, and decreased testicular size. (3)
Tsikouris and O’Hearn disagree with the FDA’s decision to change peptides’ schedule rating. Tsikouris argued that the blanket classification of all peptides is inaccurate as different peptides have different functions and should not be classified the same across the board. “Different peptides…do different healing things,” said Tsikouris.”
While there are growth hormone-releasing peptides that are potentially unsafe, most peptides have been deemed safe through clinical use. A 2019 International Journal of Molecular Sciences study presented bioactive peptides as safe and new therapies “that may fill the gap between small molecules and protein drugs.” (4)
Schedule III
Schedule III substances “may cause physical dependence but more commonly lead to psychological dependence.” They include “benzphetamine, ketamine, phendimetrazine, and anabolic steroids” and are typically prescribable via a paper prescription from an authorized physician.
[Related: The 6 Benefits of HIIT to Inspire You to Go Hard]
Schedule IV & Schedule V
Schedule IV substances include “alprazolam, carisoprodol, clonazepam, clorazepate, diazepam, lorazepam, midazolam, temazepam, tramadol, and triazolam.” Schedule V substances include “cough medicines with codeine, antidiarrheal medications that contain atropine/diphenoxylate, pregabalin, and ezogabine.”
Preventative Measures Against the FDA
Consumers go to Tsikouris’s Titan Medical Clinic for to fulfill orders of beneficial peptides. Tsikouris suggested the way to potentially reverse the FDA’s reclassification decision is if patients, doctors, pharmacies, and clinics “revolt.” Tsikouris feels the new classification might result in chemists seeking to change the molecular structure of peptides so they don’t fall within the Schedule II substance structure.
Specific FDA-approved peptides, including some fat burners, won’t be significantly affected, but most peptides will be more difficult to come by. O’Hearn believes peptides are similar to the branched-chain amino acids (BCAAs) he takes. Tsikouris expressed concern that the FDA’s reclassification doesn’t distinguish between those nuances.
The duo discussed the FDA’s concerns with intravenous peptide injections, mentioning the potential bans of injectable versions of NAD, glutathione, L-theanine, and L-arginine. While oral versions would remain available, those who offer them in IV form would suffer. No action like that has occurred, but it’s on Tsikouris’ radar.
References
- Forbes J, Krishnamurthy K. Biochemistry, Peptide. [Updated 2022 Aug 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK562260/
- Efimenko, I. V., Valancy, D., Dubin, J. M., & Ramasamy, R. (2022). Adverse effects and potential benefits among selective androgen receptor modulators users: a cross-sectional survey. International journal of impotence research, 34(8), 757–761. https://doi.org/10.1038/s41443-021-00465-0
- Martínez-Villaluenga, C., & Hernández-Ledesma, B. (2020). Peptides for Health Benefits 2019. International journal of molecular sciences, 21(7), 2543. https://doi.org/10.3390/ijms21072543
Featured image: @mikeohearn on Instagram
