FDA WARNING_LETTER - A&Z Pharmaceutical, Inc. - June 13, 2023

The FDA issued a Warning Letter to Ms. Li Xu, D-CAL USA, following a review of their websites (d-calusa.com, facebook.com/dcalusa/, facebook.com/mfitsupps/) in April 2023. The FDA determined that the product "Chewable Calcium 600MG with Vitamin D for Kids in Orange Flavor" is marketed with claims that establish it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), due to its intended use in the cure, mitigation, treatment, or prevention of disease.

Specific claims on the websites, such as those related to "VITAMIN D & IT’S BENEFITS," "CALCIUM DEFICIENCY|LOW CALCIUM SYMPTOMS," "WHAT IS CALCIUM? | CALCIUM BENEFITS," and "CONTROLLING BLOOD PRESSURE WITH THESE KEY MINERALS," indicate drug intent.

The product is deemed a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for its intended uses. Introducing or delivering a new drug into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the product is misbranded under section 502(f)(1) of the Act because it lacks adequate