FDA WARNING_LETTER - International Institute of Holistic Healing Inc.

The FDA and FTC issued a Warning Letter to Dr. Aundrea Adams of International Institute of Holistic Healing, Inc. regarding the marketing of Colloidal Silver 500 ppm (Liquid), Essaic Tonic Liquid Drops, and Oil of Oregano P73 Physician's Strength on DoctorAJAdams.com.

The FDA determined these products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act. Labeling claims, including those for treating AIDS, HIV, cancer, herpes, and various infections, classify them as drugs intended for disease treatment or prevention. As "new drugs," they require FDA-approved New Drug Applications (NDAs), which are absent. Colloidal Silver 500 ppm (Liquid) is specifically cited under 21 CFR § 310.548 for lacking data on safety and effectiveness for OTC use.

Furthermore, these products are misbranded because they lack adequate directions for use for conditions not amenable to self-diagnosis/treatment (e.g., HIV, cancer), and are considered dangerous to health under section 502(j) due to potential delays in appropriate medical care. Claims for cold sores and warts are also inconsistent with OTC Drug Review monographs.

The letter also addresses the marketing of Vaginosis Profile Vaginal Swab Test In-Home Lab Test Kit and Metabolic Analysis Profile (Organic Acids) Urine Test In-Home Lab Test Kit as devices offered directly to consumers without physician