FDA WARNING_LETTER - Applied Health Solutions, Inc. - August 31, 2021

The FDA issued a Warning Letter to Applied Health Solutions after reviewing their websites (appliedhealth.com and store.appliedhealth.com) in July-August 2021. The FDA determined that the company's products—Applied Health Solutions brand B Complex, Daily Detox, CellRenewPRO, CellRenewSTS, and NutriBiotic brand Grapefruit Seed Extract CapsulesPlus and Grapefruit Seed Extract Liquid Concentrate—are unapproved new drugs and misbranded.

The violations stem from numerous claims on the company's websites that establish the products' intended use for the cure, mitigation, treatment, or prevention of diseases, thus classifying them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of these claims include: B Complex for preventing MRSA infection and strengthening immunity; Daily Detox for lowering cancer risks, protecting against cardiovascular disease, fighting infections, and offering antioxidant protection against colds/flu; PowerZyme Prime for inhibiting Candida albicans, preventing blood clots, and reducing inflammation; Grapefruit Seed Extract products for fighting infections, cold/flu, and various pathogens including Salmonella, E. coli, Staph, Strep, viruses, herpes, parasites, and fungi, and for treating AIDS, chronic fatigue syndrome, diarrhea, and ulcers; CellRenewPRO and CellRenewSTS for repairing connective tissue, relieving joint discomfort, increasing mobility, treating chronic joint inflammation, osteoarthritis, rheumatoid arthritis, and