FDA WARNING_LETTER - Coral Calcium Factor

The FDA issued a Warning Letter to the company operating www.coralcalciumfactor.com, stating that their product "Coral Calcium Daily" is promoted as a drug due to therapeutic claims on the website. These claims, such as "CORAL CALCIUM… may make the DIFFERENCE for YOU if You Suffer from any of these life-threatening diseases" and assertions about preventing or reversing cancer, establish the product's intent for use in the cure, mitigation, treatment, or prevention of disease, violating the Federal Food, Drug, and Cosmetic Act (the Act).

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 promoted uses. New drugs require prior FDA approval, which this product lacks. Furthermore, "Coral Calcium Daily" is misbranded under section 502(f)(1) of the Act as its labeling fails to bear adequate directions for use.

The FDA requires prompt corrective action to address these violations and prevent recurrence. Failure to comply may result in enforcement actions, including seizure of products and injunctions. The company must notify the FDA in writing within fifteen working days of the specific steps taken to correct the violations, including documentation, or explain any delays and provide a timeline for completion.