The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. A warning letter is a serious notice to that a marketer appears to be violating federal law and may be subject to enforcement action if the apparent violation continues. Enforcement actions include seizure of goods, injunctions, criminal prosecutions, fines, and imprisonment.
Most sellers do what the FDA requests. In some cases, the product must be removed from the marketplace. In others, marketing can continue as long as the claims to which the FDA objected are stopped. Regardless of the outcome, it is wise for consumers to assume that the product is problematic and should be avoided.
- Advanced Spine and Pain, LLC d/b/a Relievus / Young J. Lee, MD (3/28/19): CBD Salve, CBD Oil” (in 5 different flavors), CBD for Dogs
- B. Jain Pharmaceuticals Private, Ltd. / Kuldeep Jain (3/21/19: Ring Relief Ear Drops, Ring Relief Fast Dissolving Tablets
- Mark Berman, MD (2/13/19): Pocket protector used during breast augmentation procedure
- Blue Ridge Silver / Steven Griffin (2/5/19): Colloidalk silver products
- John Gray’s Mars Venus LLC / John Henderson Gray (2/5/19): 2-AEP Membrane Complex, Ionic Silver Water, L-Glutathione, Liposomal DHA – Ultimate Omega-3 Brain Support, Liposomal Methyl B12/Folate, NAC N-Acetyl-L-Cysteine, Vectomega
- King Bio / Dr. Frank King (3/20/19): Cold Sores & Herpes, Adrenal Burnout, Lymph Detox, and manufacturing violations
- Nutra Pharma Corp. / Rik J. Deitsch (3/11/19): Nyloxin Oral Spray, Nyloxin Topical Gel Nyloxin Topical Roll-On, Nyloxin Topical Roll-On ES, Nyloxin Professional Size Pump Topical Gel, Regular Strength Sample Pack
- Phi Sciences / Dr. Patrick Flanagan (1/30/19): Mega Hydrate Powder, Mega Hydrate Capsules, Crystal Energy
- Red Mountain Inc/ Henry B. Schur (3/20/19): Bioven
- Sovereign Laboratories, LLC / Douglas Wyatt (2/5/19): Colostrum-LD, Viralox, and Curcumin-LD
- TEC Laboratories / Steven D. Smith (3/20/19): LiceFreee Spray! Head Lice Treatment, Calagel First Aid Antiseptic, Skin Protectant, and Topical Analgesic
This page was revised on May 6, 2020.