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Posted February 17, 2022

Seller of L-Theanine, Lutein, Noopept and More Warned for Drug Claims

On February 4, 2022, the FDA issued a warning letter to Crystal Clear Supplements following a review of the company’s website and social media which found statements about Tianeptine Sodium Powder, Tianeptine Sulfate Powder, PEA Capsules, Phenibut Capsules, Synephrine Powder, Noopept Powder, L-Theanine Capsules, and Lutein Capsules to be drugs claims. In addition, products containing tianeptine, Tianeptine Sulfate Powder and Tianeptine Sodium Powder, are unapproved drugs in the United States.

The agency warned that the products are considered to be “new drugs” because “they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.” For example, the company website promotes L-Theanine Capsules with statements such as, “…L-theanine is neuroprotective and can improve symptoms of depression, anxiety, insomnia, and cognitive impairment…” Lutein Capsules were promoted with statements such as, “Lutein is used to prevent cataracts and can, over time, improve vision for people with cataracts…lutein may be beneficial for people suffering from heart disease, breast cancer, colon cancer, and type 2 diabetes.”

The company has 15 days to respond to the FDA in writing, outlining the steps taken to correct these violations.

See ConsumerLab’s ReviewS of L-Theanine Supplements and Vision Supplements (such as Lutein) for tests of related products.

Also seeour answer to the question What is Noopept? Can it really improve memory and cognition, and is it safe?

For more information, use the link below.

Warning Letter: Crystal Clear Supplements

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