FDA WARNING_LETTER - Living Naturally

The FDA issued a Warning Letter to Green Earth Health Food Market after reviewing their website, www.greenearthoneonta.com. The FDA determined that four products—"Kyolic Original Formula 100," "Nature's Way Sarsaparilla Root," "Nutrition Now PB 8 Pro-Biotic Acidophilus," and "Nature's Way Alfa-Max"—are promoted with therapeutic claims that classify them as unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

Specific claims cited include "Kyolic Original Formula 100" for blood pressure, cholesterol, heart disease, cancer, and infections; "Nature's Way Sarsaparilla Root" for congestive heart failure, high blood pressure, and arthritis; "Nutrition Now PB 8 Pro-Biotic Acidophilus" for anti-fungal activity, yeast infections, and cancer prevention; and "Nature's Way Alfa-Max" for allergies, anemia, arthritis, and diabetes.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their promoted uses and lack prior FDA approval. They are also "misbranded" because adequate directions for use by a layperson cannot be provided for conditions not amenable to self-diagnosis and treatment. The introduction of these misbranded drugs into interstate commerce violates the Act.

The FDA noted that other products on the website also had unlawful disease treatment and prevention claims. Green Earth Health Food Market