# FDA WARNING_LETTER - Market America Inc - May 28, 2019

Source: https://www.keypedia.com/records/warning_letter/market-america-inc/43930ccc-f46c-406b-8b17-512fed7cbdc1

> FDA WARNING_LETTER for Market America Inc on May 28, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Market America Inc
- Inspection Date: 2019-05-28
- Product Type: Food
- Office Name: Office of Human and Animal Foods – East 5
- Summary: The FDA conducted an inspection of a dietary supplement distributor in Greensboro, NC, from May 21-28, 2019, identifying serious violations of the Federal Food, Drug, and Cosmetic Act.

A primary violation was the failure to submit Serious Adverse Event Reports (SAERs) as required by section 761(c) of the Act. Two specific instances were cited: a March 15, 2018 complaint regarding TLS Nutrition Shake leading to prolonged hospitalization and physical therapy, and a January 28, 2019 complaint concerning TLS 21-Day Challenge Kit products resulting in inpatient hospitalization for various adverse reactions. The firm's July 11, 2019 response provided revised procedures for assessing adverse event severity but did not address a retrospective review of past events.

Additionally, several products (Isotonix OPC-3, Heart Health Essential Omega III, Isotonix Multivitamin, Isotonix Multivitamin with Iron, Isotonix Activated B-Complex) were deemed misbranded under section 403 of the Act due to non-compliance with 21 CFR 101 labeling requirements. Specific misbranding issues included incorrect serving size declaration (Isotonix OPC-3), improper presentation of nutrition information (e.g., declaring zero-amount ingredients, incorrect naming conventions for dietary ingredients), and failure to identify the plant part for botanical ingredients (Isotonix OPC-

## Related Officers

- [Ingrid A. Zambrana](https://www.keypedia.com/people/ingrid-a-zambrana/122ef711-2d89-489b-a5e9-82893f58dd8f)
- [Patricia F. Hudson](https://www.keypedia.com/people/patricia-f-hudson/8cddc479-3c89-4058-b850-2d07a312c40b)

Company: https://www.keypedia.com/companies/market-america-inc/9542ea12-35f8-42b4-8a27-088105e0ee2b

Office: https://www.keypedia.com/offices/office-of-human-and-animal-foods-east-5/a29c71e7-2159-4e97-8fd8-4fcdf7131844