Longevity

Dynamic Stem Cell Therapy

FDA's Center for Biologics Evaluation and Research issued a warning letter to Dynamic Stem Cell Therapy (Henderson, NV), directed to Medical Director Dale Carrison, D.O., for marketing an unapproved, unlicensed umbilical cord-derived stem cell product and exosomes via stemcellpowernow.com. The products were found to be unapproved new drugs and unlicensed biological products under the FD&C Act and PHS Act, and the stem cell product was deemed misbranded because it lacked adequate directions for use. FDA warned that failure to address these violations may result in seizure and/or injunction, and required a written response within 15 working days.

Private Label Skin Care, Inc.

FDA issued a warning letter to Private Label Skin Care, Inc. (Canoga Park, CA) following a June 2025 inspection that found significant CGMP violations and drug listing failures. The company, which uses a contract manufacturer, continued distributing OTC drug products with elevated impurities after being notified of the problem, and ultimately issued a voluntary recall. Additionally, the firm failed to provide required drug listings for at least 21 OTC drug products, rendering them misbranded under the FD&C Act. FDA demanded a written corrective action response within 15 working days and warned that failure to comply could result in seizure, injunction, or withholding of export certificates and new application approvals.

Stem Cell Institute of America, LLC

The FTC and Georgia Attorney General's Office sued the co-founders of Stem Cell Institute of America, LLC in August 2021 for marketing stem cell therapy to seniors using unsubstantiated claims that the treatment is effective for arthritis, joint pain, and other orthopedic conditions. In January 2025, two court orders were entered settling the complaint and barring the company from the allegedly illegal conduct. The case represents a coordinated federal-state enforcement action targeting deceptive health marketing directed at a vulnerable population.

ISIS.GOLD

FDA issued a warning letter to ISIS.GOLD (Michelle Golde, Elmhurst, IL) on July 25, 2024, concerning two chemical peel products — 'TCA 100% Trichloroacetic Acid' and 'Whitening SA Peels' — sold on the company's website. The products were found to be unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act due to drug-intent claims such as removing warts, treating melasma, and anti-aging effects, without any FDA-approved application in effect. FDA flagged public health risks including burns, scarring, and injuries requiring emergency care. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

Aqualex Co., Ltd.

FDA issued a warning letter to Aqualex Co., Ltd., a South Korean OTC sunscreen drug manufacturer, citing multiple CGMP violations (process validation, water system design, quality unit failures, inadequate release and stability testing) and declaring their 'DBH Beverly Hills, EGF FGF DNA, UV Shield' product an unapproved new drug. The product's website marketing claims for EGF, FGF, and DNA ingredients as anti-aging and cell-repair actives rendered them unapproved active ingredients outside the OTC sunscreen monograph. The product was also found misbranded for contradictory labeling (claiming 'OCTINOXATE FREE' while listing octinoxate as an active ingredient), missing manufacturer identity, and use of non-established ingredient names. FDA placed the firm on Import Alert 66-40 and required a written response within 15 working days.

Quantum Wellness Botanical Institute, LLC

Quantum Wellness Botanical Institute, LLC, sellers of a supplement called ReJuvenation, settled FTC charges in January 2020 for deceptively marketing their product as a cure-all for age-related ailments including cell damage, heart attack damage, brain damage, blindness, and deafness. The FTC's complaint alleged these claims were unsubstantiated. The settlement orders prohibit defendants from making such claims without true and scientifically supported evidence, and require payment of $660,000 for consumer redress, with over $149,000 in refund checks distributed to affected consumers by June 2020.