FDA WARNING_LETTER - Arden's Garden

The FDA issued a Warning Letter to Mrs. Zinn due to serious violations of the Federal Food, Drug, and Cosmetic Act concerning her product labels.

Several products, including Veg-Aholic, Pure Lemon, Beet it Better, and Pump up the Protein, are deemed unapproved new drugs because their labels make therapeutic claims (e.g., "lower cholesterol," "fight cancer," "promote wound healing," "reduce coronary heart disease," "prevent osteoporosis"). These products are not generally recognized as safe and effective for these uses and lack FDA approval. Furthermore, they are misbranded as they lack adequate directions for layperson use for conditions not amenable to self-diagnosis.

The REAL ENERGY product is adulterated because it contains ginkgo biloba extract, an unapproved and unsafe food additive. This substance is not authorized by food additive regulations, nor is it generally recognized as safe (GRAS) for use in conventional foods.

Additionally, several products are misbranded. "Complete Recovery" is misbranded for using "Fresh" on its label despite being made with (b)(4) and (b)(4) ingredients, violating 21 CFR 101.95. "Veg-Aholic," "2 Day Detox," and "Complete Recovery" bear unauthorized nutrient content claims (e.g., "Full of," "loaded with," "more than double the nutrients") that do not comply with regulatory definitions or requirements for quantitative information and reference values