Recalls and Warnings

Company Failed to Report Adverse Events Associated With Its Nutrition Shakes

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If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem.
(Date Posted: 2/26/2020)

On February 12, 2020, the FDA sent a warning letter to Market America Inc for failure to submit serious adverse event reports about two of its products, as required by federal regulation. The company received two reports following serious adverse events but did not submit the proper forms:

  • On March 15, 2018, Market America received a complaint after a consumer was hospitalized for becoming winded, experiencing vertigo symptoms, and inability to walk after using the company's TLS Nutrition Shake. The consumer required six weeks of physical therapy to regain the ability to walk.

  • On January 28, 2019, a complaint reported hospitalization due to abdominal pain, constipation, vomiting, dizziness, itching of skin, weakness, shaking, insomnia, chills, headache, tingling and numbness, and cramps after one week of using the TLS 21-Day Challenge Kit, which includes the products TLS Nutrition Shakes, Isotonix OPC-3, NutriClean 7-DayCleansing System, and TLS Core.
Adverse reaction complaints do not prove that a product was the direct cause of an illness or injury, but dietary supplement companies are required them to the FDA.

Consumers and healthcare providers can report any adverse reactions to dietary supplements to the FDA's MedWatch Voluntary Reporting Program. Consumers can also report problems or adverse events using ConsumerLab's Supplement or Nutritional Product Problem Report.

In addition, some of the company's products were found to be misbranded because they do not comply with dietary supplement labeling requirements. These products include Isotonix OPC-3, Heart Health Essential Omega III, Isotonix Multivitamin, Isotonix Multivitamin with Iron, Isotonix OPC-3, and Isotonix Activated B-Complex.

See ConsumerLab's Reviews for Omega-3, Multivitamin, Iron, and Vitamin B Supplements for tests of related products.

See Related Warnings:

Weight Loss, Muscle & Energy Supplements Linked to Adverse Events in Children and Young Adults" Warns FDA

Adverse Effects From Energy Drinks Common Among Youth and Young Adults

Adverse Event Reports Associated With Dietary Supplements Increase, But Remain Underreported And Underutilized

For more information, use the link below.

Market America Inc



For other Recalls and Warnings click HERE.
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.


 

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