# FDA WARNING_LETTER - Dual Health Body and Mind - March 01, 2018

Source: https://www.keypedia.com/records/warning_letter/dual-health-body-and-mind/07eb7bc6-a511-4829-a6af-1d3dabe86ac8

> FDA WARNING_LETTER for Dual Health Body and Mind on March 01, 2018. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Dual Health Body and Mind
- Inspection Date: 2018-03-01
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA issued a Warning Letter to Dual Health Body and Mind in May 2018, following a January 2018 review of their 8-ounce Caffeine Anhydrous Powder product label and a March 2018 website review. The product, labeled as a dietary supplement, was found to be adulterated under section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act because it presents a significant or unreasonable risk of illness or injury under recommended conditions of use.

The product's label recommends a "1/16 teaspoon (200mg)" serving, 1-3 times daily. The FDA determined that a 200mg serving cannot be accurately measured with common household tools, including a 1/16 teaspoon, due to factors like powder packing and "heaping" scoops. A simple measurement error could lead to dangerous or toxic doses. A single teaspoon of pure powdered caffeine is equivalent to approximately 28 cups of coffee (2.7 grams), and consuming even one teaspoon can cause severe symptoms, while a tablespoon (8.1 grams) has been associated with chest pain, irregular heartbeat, and death.

The 8-ounce package contains approximately 227 grams, or over a thousand recommended servings, with larger packages up to 5.5 pounds (approximately 12,500 servings) also sold. The FDA concluded that the

## Related Officers

- [Shawn Goldman](https://www.keypedia.com/people/shawn-goldman/e74379e1-661b-4034-90f2-0bc6af245a67)
- [Director](https://www.keypedia.com/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.keypedia.com/companies/dual-health-body-and-mind/95126a00-e7e9-448c-8989-2dd53a83a502

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2