What happened
Original notice title
Nd Labs, Inc. 9/1/17
From the archived source record
Based on the inspection and review of the product labels you provided during the inspection, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations as described below. Medical Foods Your LPS Cherry, Liquid Fiber Flow, and Nana Flakes products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C § 343(a)(1)] because the product labeling is false and misleading in that the products are labeled and marketed as medical foods but do not meet the definition of a medical food in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] or the criteria set forth in Title 21 Code of Federal Regulations section 101.9(j)(8) [21 C.F.R. 101.9(j)(8)]. Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms, or reduce the risk of a disease or condition. Unapproved New Drugs In addition, we reviewed your website at the Internet address nutritionaldesignsinc.com in August of 2017 and have determined that you take orders there for LPS Cherry, Liquid Fiber Flow, Nana Flakes and CVF (Cereal Vegetable Fruit Fiber) products. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your LPS Cherry, Liquid Fiber Flow, and CVF (Cereal Vegetable Fruit Fiber) products fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Misbranded Conventional Food Even if your LPS Cherry, Liquid Fiber Flow, and Nana Flakes products were not unapproved new drugs, the products would still be misbranded foods under section 403 of the Act [21 U.S.C. § 343] because the products do not comply with the labeling requirements for conventional foods as described below: 1.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 127453c362ed
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →