On June 28, 2023, the FDA issued a warning letter to Eden’s Answers, Inc. after an inspection of the company’s facility found products to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP).

Violations noted in the FDA’s warning letter include failure to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, failure to include the date and time of the maintenance, cleaning, and sanitizing of the equipment, and failure to establish qualitative or quantitative parameters to which a test result can be compared to verify the identity, purity, strength, and composition of dietary supplements such as the company’s Lil’ Ones Sleepy Time products.

The FDA also stated the the company’s Honey Herbal Syrup and Lil’ Ones Sleepy Time products were misbranded because the labels did not include required information such as nutrition information, serving size, and number of servings per container.

Eden’s Answer, Inc. must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

For more information about related products, see ConsumerLab’s Review of Melatonin Supplements.

Also see CL’s answers to the following questions:

What are the best supplements or lifestyle modifications for sleep, and which can make insomnia worse?

What are the health benefits of manuka honey, and is it safe?

For more information, use the link below.

Warning: Eden’s Answers, Inc.

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