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Notice: Official Public Record

Is Innovita, LLC Safe? FDA Warning Letter Review (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on August 21, 2017

MODERATE SEVERITY Denver District Office 2017
Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to Innovita, LLC on August 21, 2017 citing unapproved drug claims, misbranding, adulteration. The letter was issued by Denver District Office.

Unapproved Drug Claims Misbranding Adulteration CGMP Violations Labeling Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA reviewed your website at the Internet address http://www.inno-vita.com/index.htm in August 2017, and has determined that you take orders there for your Phung-Ex, Micro-Site, Kardi-Air, Pro-Prosta, Xpleen, Immunis, and Bacto-Ex capsule products. In addition, we have reviewed your product labels for Phung-Ex, Immunis, Hysta-Min, and Bacto-Ex capsule products collected during the February 2017 inspection. The claims on your website and product labeling establish that these 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 further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the A

Examples of some of the claims on your website and your product labeling that provide evidence that your products are intended for use as drugs include:

Your Kati-Air product is intended for treatment of one or more diseases that are not amenable to self diagnosis or treatment without the supervision a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, KariAir fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].

Potential Health Risks

Phung-Ex• "Remove Spore Organism ... "• "Phung-Ex helps the body rid itself of harmful mold, yeast and fungus, and eliminates unfriendly microorganisms in the digestive tract. .. "• "Helps body to end the proliferation of dangerous fungus and end its toxic by-products ... "• "Helps body's own ability to effectively remove haimful funguses .... "

Bacto-Ex capsules• "Bacto-Ex ... Remove Single Cell Microorganism ... "• "[H]elps the body shield and fight again harmful microorganisms ... "

Regulatory Context

From February 24, 28, and 29 and March 1, 3, and 6, 2017, the U.S. Food and Drug Administration (FDA) inspected your facility located at 3149 Midland Drive, Ogden, Utah. During the inspection, our investigator found a number of violations of the current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplements to be adulterated under within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under insanitary conditions that do not meet cGMP regulations for dietary supplements.

In addition, we have reviewed your website at the Internet address at http://www.inno-vita.com/index.htm and your product labeling. Based on our review, we have concluded that certain products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA's website atwww.fda.gov.

Unapproved New Drugs and Misbranded Drug Violations

Key Entities Identified

21 CFR 111 21 CFR 101 21 CFR 111.70 section 402(g) section 201(g) section 201(p)

Frequently Asked Questions

What did the FDA find wrong with Innovita, LLC?
The FDA issued a warning letter citing unapproved drug claims, misbranding related to their products or manufacturing practices.
Are Innovita, LLC 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 Innovita, LLC products?
If you have used products from Innovita, LLC 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
Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.