Peak Performance Peptides
FDA issued a warning letter to Peak Performance Peptides (Jeffrey Deng, Phoenix, AZ) for selling unapproved new drugs — including retatrutide (GLP-3R), semaglutide, SS-31, PT-141, tesamorelin, and bacteriostatic water — via the website pppepz.com without valid FDA-approved applications under section 505(a) of the FD&C Act. The products were marketed with drug-intent claims despite 'research use only' disclaimers, and the co-sale of bacteriostatic water confirmed intended human injectable use. FDA warned that failure to correct violations may result in seizure and injunction, and required a written corrective response within 15 business days.
Flagged claims (30)
Considered in preclinical models of sexual health and neuroendocrine research
GLP-3R has been explored for its influence on appetite suppression, energy expenditure, and fat distribution. It is commonly considered in preclinical models studying obesity, metabolic health, and endocrine signaling.
Considered in preclinical models of endocrine and cardiometabolic research
GLP-3R is a synthetic peptide under investigation for its potential effects on metabolic regulation, body weight management, and glycemic control. It acts as a multi-receptor agonist targeting GIP, GLP-1, and glucagon receptors in research settings.
Investigated for influence on appetite regulation and satiety pathways
PT-141 is a synthetic peptide studied for its potential effects on sexual arousal and neuroendocrine regulation. It acts on melanocortin receptors, influencing central nervous system pathways related to libido and reproductive signaling.
Tesamorelin has been investigated for its effects on body composition, lipid metabolism, and tissue repair. It is commonly used in preclinical research exploring endocrine regulation, fat distribution, and regenerative pathways.
Semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist studied for its potential effects on glucose regulation, appetite control, and metabolic health.
Explored for potential effects on body composition and tissue repair
Investigated for effects on oxidative stress and cellular health
Studied for stimulation of endogenous growth hormone release
Explored for potential impact on body weight and metabolic health
Investigated for influence on metabolism and lipid regulation
Studied for effects on glycemic control and insulin sensitivity
Investigated for influence on appetite regulation and satiety pathways
Tesamorelin is a synthetic growth hormone–releasing hormone (GHRH) analog studied for its role in stimulating endogenous growth hormone secretion and regulating metabolic pathways.
Investigated for modulation of melanocortin receptors and CNS pathways
Explored for influence on reproductive endocrine signaling
PT-141 has been investigated for its effects on sexual behavior, central nervous system modulation, and endocrine signaling. It is commonly considered in preclinical models exploring sexual health, reproductive research, and neuroendocrine pathways.
Studied for effects on insulin secretion and glycemic control
Considered in preclinical models of endocrine and metabolic research
Studied for mitochondrial protection and enhancement of energy metabolism
Studied for effects on sexual arousal and libido
Explored for potential neuroprotective and cardiovascular benefits
Considered in preclinical models of cardiometabolic and metabolic research
Considered in preclinical models of aging, metabolic, and degenerative diseases
SS-31 (Elamipretide) is a mitochondria-targeted peptide studied for its potential to reduce oxidative stress, improve mitochondrial function, and support cellular energy production.
Explored for potential impact on body weight and fat distribution
Semaglutide has been investigated for its influence on insulin secretion, satiety pathways, and body weight management. It is commonly considered in preclinical models exploring endocrine signaling, diabetes, and obesity-related research.
SS-31 has been investigated for its effects on mitochondrial health, neuroprotection, and cardiovascular function. It is commonly considered in preclinical models exploring metabolic disorders, age-related diseases, and tissue protection.
Required actions (3)
Send your written response to [email protected] within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence.
Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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