An advisory committee for the Food and Drug Administration on July 23 recommended four controversial peptides to the list of ingredients compounding pharmacies are allowed to use, which is known as the Section 503A Bulk Drug Substances List.
The names of the peptides that were recommended to the FDA by the Pharmacy Compounding Advisory Committee (PCAC) included BPC-157, KPV, TB-500, and MOTS-c.
The peptides’ uses ranged from helping people manage obesity to aiding wound healing, combating eczema, treating inflammatory conditions, and managing ulcerative colitis.
Here is an explanation of the peptides that were recommended.
BPC-157
The PCAC voted 8–6 to recommend BPC-157 (free base and acetate) to the FDA’s Section 503A Bulk Drug Substances List.
BPC-157, also called stable gastric pentadecapeptide, is an anti-ulcer peptide that was used in trials to treat ulcerative colitis, multiple sclerosis, and inflammatory bowel disease, according to the National Institutes of Health.
Critics warned the advisory committee on Thursday that even though millions of people were taking it without FDA approval, there were limited studies on the efficacy and effectiveness of the substance.
Three users reported adverse events after taking BPC-157, including a 55-year-old woman who reported nine days of redness and swelling, a 28-year-old man who experienced shortness of breath and went to the emergency room, and a 40-year-old woman who had diffuse hyperpigmentation and gingival darkening.
Indiana-based board-certified urologist Dr. Alex Tatem suggested to the committee that BPC-157 “holds the promise of helping heal the gut lining.”
Board-certified physician Dr. Kenneth Varano told The Epoch Times that the injectable version of BPC “has been life-changing” to his patients in Pennsylvania who suffered from injuries or post-surgical needs.
“The oral form of BPC-157 is often combined with an even more powerful GI healing peptide, KPV,” Varano added. “And there is some good data being accumulated right now on KPV’s gut healing effects.”
KPV
The PCAC voted 8 to 6 to recommend KPV (free base and acetate) to the FDA’s Section 503A Bulk Drug Substances List.
The peptide, which can be taken as an injectable, oral, topical, or nasal spray, was recommended to be used for wound healing and inflammatory conditions.
Critics said that there wasn’t enough evidence that the substance worked due to lack of studies, while supporters of the peptide touted its several potential uses, which expanded into the beauty industry.
“I know some women who like to mix it with GHK and Snap-8 and put it in their daily moisturizer and put it on their face,” Mike Stone, the founder of ReVia, told the FDA committee on July 23. “They swear it’s a heck of a lot cheaper than plastic surgery.”
GHK-Cu is a common ingredient used in anti-aging products, while Snap-8, often called “Botox in a bottle,” relaxes facial muscles to reduce the appearance of wrinkles.
TB-500
The PCAC voted 8–6 to recommend TB-500 (free base and acetate) to the FDA’s Section 503A Bulk Drug Substances List.
The peptide is used for wound healing and recovery promotion, but Dr. Stephen Cosentino, a board-certified physician, told the Epoch Times that the hype behind it may not match its efficiency.
Members of the Pharmacy Compounding Advisory Committee who voted no suggested there was a “lack of fundamental information” about the drug and warned that this particular drug was being mixed with other peptides.
MOTS-c
MOTS-c (free base and acetate) is a peptide that can be used to curb obesity and osteoporosis, according to NIH.
The Pharmacy Compounding Advisory Committee (PCAC) voted to recommend it to be added to the FDA’s Section 503A Bulk Drug Substances List on a 7-to-5 vote. Two abstained.
“MOTC is another naturally occurring peptide that declines with age and has direct effects on metabolism, fat burning, and sugar burning,” said Varano.
Thursday’s discussion about MOTS-c featured a speech by Dr. Pinchas Cohen, the founder of a biotech company that moved MOTS-c into clinical trials after discovering it in his lab.
Cohen described the substance as a “very potent metabolic regulator with influence on muscle biology,” adding that it can lead to weight loss, elimination of fat accumulation in the liver, and even improve insulin sensitivity.
The members who voted no suggested they were concerned about the lack of human trials and data for efficacy.
More Peptides Being Considered
The PCAC will consider three additional peptides on July 24. The peptides up for discussion on July 24 include Emideltide, Semax, and Epitalon.
Emideltide has been used for opioid withdrawal, chronic insomnia, and narcolepsy. Semax has been used by people suffering from cerebral ischemia, migraine, and trigeminal neuralgia. Epitalon acetate has been used for Insomnia.
Votes by the committee are non-binding and will still require FDA approval.
