Nature's Vision, Inc FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on May 01, 2017
Executive Summary
The FDA issued a warning letter to Nature's Vision, Inc on May 01, 2017 citing unapproved drug claims, misbranding, adulteration. The letter was issued by Detroit District Office.
Detailed Analysis
False Claims and Regulatory Violations
The claims on your website for your Cinnamon Extract tablets and Alpha Lipoic Acid tablets, and the claims on your product labels for Elderberry Ultimate Immune Response and Party Recovery products establish that the products are drugs under section 201 (g)(1)(B) of the Act [21 U.S.C. 321 (g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the claims that provide evidence that these products are intended for use as drugs include:
Alpha Lipoic Acid website claim:• "[its] primary objective [is to] to protect cells from the oxidation which is a natural component of .... disease."
Potential Health Risks
Consumers should be aware of potential risks associated with products from Nature's Vision, Inc.
Regulatory Context
On August 30, September 7, and October 4, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 50744 25th Street, Mattawan, Michigan, where your firm receives, holds, and distributes dietary supplements, drugs, and cosmetics. Based on the inspection, a review of the product labeling you provided during the inspection, and our subsequent review of your website www.naturesvisioninc.com, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA's website atwww.fda.gov.
In March, 2017, we reviewed your product labeling, including product labels and your website at the internet address http://naturesvisioninc.com, where you take orders for several of your dietary supplement products, including Cinnamon Extract tablets and Alpha Lipoic Acid tablets. Additionally, we reviewed the labels for your Elderberry Ultimate Immune Response and Party Recovery Detox Tablets.
Your Cinnamon Extract tablets, Alpha Lipoic Acid tablets, Elderberry Ultimate Immune Response and Party Recovery products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are new drugs as defined in section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Nature's Vision, Inc?
- The FDA issued a warning letter citing unapproved drug claims, misbranding related to their products or manufacturing practices.
- Are Nature's Vision, Inc products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have unapproved drug claims that may affect product safety.
- What should I do if I've used Nature's Vision, Inc products?
- If you have used products from Nature's Vision, Inc and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter