On June 1, 2023, the FDA issued a warning letter to A&Z Pharmaceutical, Inc. following inspection of the company’s website and social media, which found statements about the company’s Chewable Calcium 600MG with Vitamin D for Kids in Orange Flavor products to be drug claims.

For example, products were promoted with statements such as “But, by upping your vitamin D levels, you can help re-mineralize bone structures, making them stronger…It could also help prevent osteoporosis, a condition affecting over 53 million people...” and “Vitamin D reduces depression…Research has shown that vitamin D might play an important role in regulating mood and warding off depression…” The company’s Chewable Calcium 600MG with Vitamin D for Kids in Orange Flavor was also promoted with statements suggesting it could prevent or treat gum disease, hypocalcemia, colon cancer, hair loss, and other conditions.

The FDA also stated that A&Z’s Chewable Calcium 600MG with Vitamin D for Kids in Orange Flavor was misbranded because the label and packaging do not provide adequate directions for use.

A&Z Pharmaceutical, Inc. is required to 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 and tests of related products, see ConsumerLab’s Calcium Supplements Review and Vitamin D Supplements Review.

Also see:

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Do any supplements or diets help prevent or treat osteoporosis?

For more information, use the link below.

Warning: A&Z Pharmaceutical, Inc.

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