FDA WARNING_LETTER - Nd Labs, Inc. - September 23, 2016

On September 1, 2017, the FDA issued a Warning Letter to ND Labs, Inc. following an inspection on September 20 and 23, 2016. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act.

The products LPS Cherry, Liquid Fiber Flow, and Nana Flakes are misbranded as medical foods because they do not meet the definition or criteria for medical foods under the Orphan Drug Act and 21 CFR 101.9(j)(8). The FDA is not aware of distinctive nutritional requirements for the conditions these products claim to address.

Additionally, LPS Cherry, Liquid Fiber Flow, Nana Flakes, and CVF (Cereal Vegetable Fruit Fiber) are deemed unapproved new drugs under section 201(g)(1)(B) of the Act due to therapeutic claims on labels and the company website (nutritionaldesignsinc.com). These products are not generally recognized as safe and effective for their claimed uses, making them "new drugs" requiring FDA approval. Furthermore, LPS Cherry, Liquid Fiber Flow, and CVF are misbranded drugs under section 502(f)(1) as they lack adequate directions for layperson use, being intended for conditions requiring professional supervision.

Even if not unapproved drugs, LPS Cherry, Liquid Fiber Flow, and Nana Flakes are misbranded conventional foods due to incorrect nutrition facts formatting (e.g., Nana Fl