A&Z Pharmaceutical, Inc.
FDA issued a warning letter to A&Z Pharmaceutical, Inc. (Hauppauge, NY) regarding its Chewable Calcium 600MG with Vitamin D for Kids product, finding that disease-treatment claims on the company's website and Facebook pages rendered the dietary supplement an unapproved new drug under the FD&C Act. Flagged claims included assertions that the product could prevent osteoporosis, treat hypocalcemia, lower blood pressure, reduce depression, and cut the risk of COVID-19. FDA also found the product misbranded for lacking adequate directions for use. The company was directed to respond within 15 working days and warned that failure to act could result in seizure or injunction.
Flagged claims (11)
Children who don't get enough vitamin D may not grow as much as others their age. They also have a chance of getting a rare disease called rickets, which causes bone pain and soft, weak bones that can lead to bone deformities…
It could also help prevent osteoporosis, a condition affecting over 53 million people...Some studies have found that vitamin D can actually slow down bone loss, warding off osteoporosis and keeping you stronger for longer.
The safest and easiest way to prevent hypocalcemia is by incorporating more calcium to your diet…For those who can't meet their calcium recommended daily intake through their diets alone, calcium supplements are highly effective at maintaining healthy calcium levels…
[C]alcium supplements are tied to several health benefits including…lowering the risk of colon cancer…
Low levels of vitamin D are associated with alopecia or hair loss. Adding vitamin D and calcium supplements may help create new hair follicles, which can play a role in hair growth.
Vitamin D reduces depression…Research has shown that vitamin D might play an important role in regulating mood and warding off depression. In one study, scientists found that people with depression who received vitamin D supplements noticed an improvement in their symptoms.
Calcium supplements are the standard defense-mechanism for treating and preventing bone-related diseases such as osteoporosis.
If you suffer from osteopenia, you need between 1,000 and 1,200 milligrams of calcium per day, but, you also need 800 international units (IU) of vitamin D per day to help strengthen bones and treat your symptoms.
[Vitamin D] can protect against gum disease…Researchers recently discovered that low vitamin D levels are linked to periodontitis, or gum disease.
Did you know vitamin D can help cut the risk of Covid-19? Remember to maintain a normal vitamin D intake level!..."HOW VITAMIN D CUTS THE RISK OF COVID-19…Covid-19 death rate by sunshine vitamin level…4.1% NORMAL***87.8%INSUFFICIENT…98.9% DEFICIENT..."
Research suggests calcium can help control high blood pressure, as it has been shown in several clinical trials that indicate increased calcium intake is linked to lower blood pressure and lower risk of hypertension.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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