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# A&Z Selling Illegal New Kids’ Drug
- URL: https://www.fdaweb.com/a-z-selling-illegal-new-kids-drug/
- Published: 2023-06-13T12:00:00.000Z
- Updated: 2026-09-14T18:38:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154675

An FDA review of the Web site and social media pages maintained by A&Z Pharmaceutical in Hauppauge, NY, determined that the firm takes orders for Chewable Calcium 600 mg with Vitamin D for Kids in Orange Flavor. A 6/1 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/az-pharmaceutical-inc-645101-06012023?ref=fdaweb.com) lists quotes from the Website making claims for the product that demonstrate it is intended to be used as a drug.

“Your product is not generally recognized as safe and effective for the above-referenced uses and, therefore, the product is a ‘new drug,’” the letter says. “…\[N\]ew drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA…. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”

The letter says the product is misbranded because it fails to bear adequate directions for its intended use and it is impossible to write such directions since the product is intended to treat one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.

A&Z was told to respond with a list of specific steps it has taken to address the violations, with related documentation and a schedule for completing the corrections.