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  5. A&Z Pharmaceutical, Inc. - 645101 - 06/01/2023
  1. Warning Letters

WARNING LETTER

A&Z Pharmaceutical, Inc. MARCS-CMS 645101 —


Delivery Method:
United Parcel Service
Product:
Dietary Supplements
Food & Beverages

Recipient:
Recipient Name
Emma Qingbo Li Xu
Recipient Title
Chairwoman/CEO
A&Z Pharmaceutical, Inc.

180 Oser Ave., Suite 300
Hauppauge, NY 11788-3709
United States

emmaerwin@azpharmaceutical.com
Issuing Office:
Division of Human and Animal Food Operations East I

United States


WARNING LETTER
CMS # 645101


Dear Ms. Li Xu:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://d-calusa.com/ and your social media websites at https://www.facebook.com/dcalusa/ and https://www.facebook.com/mfitsupps/ in April 2023 and has determined that you take orders at https://d-calusa.com/ for the product Chewable Calcium 600MG with Vitamin D for Kids in Orange Flavor. The claims on your websites establish that the product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your Chewable Calcium 600MG with Vitamin D for Kids in Orange Flavor product is intended for use as a drug include:

On the website https://d-calusa.com/ home page in the linked article titled: “VITAMIN D & IT’S BENEFITS”:

  • “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...Some studies have found that vitamin D can actually slow down bone loss, warding off osteoporosis and keeping you stronger for longer.”
  • “[Vitamin D] can protect against gum disease…Researchers recently discovered that low vitamin D levels are linked to periodontitis, or gum disease. Their study found those with chronic gum disease also had very low levels of vitamin D in the blood.”
  • “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.”

On the website https://d-calusa.com/ Health & Wellness page in the linked article titled: “CALCIUM DEFICIENCY|LOW CALCIUM SYMPTOMS”:

  • “How to Prevent Hypocalcemia?...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…In addition, sometimes taking vitamin D supplements may be necessary to increase the absorption of calcium in the digestive tract.”

On the website https://d-calusa.com/ Health & Wellness page in the linked article titled: “WHAT IS CALCIUM? | CALCIUM BENEFITS”:

  • “[C]alcium supplements are tied to several health benefits including…lowering the risk of colon cancer…”
  • “Calcium supplements are the standard defense-mechanism for treating and preventing bone-related diseases such as osteoporosis.”

On the website https://d-calusa.com/ Health & Wellness page in the linked article titled: “CONTROLLING BLOOD PRESSURE WITH THESE KEY MINERALS”:

  • “Last, but not least, there’s a strong link between healthy calcium levels and controlled blood pressure. Besides being the cornerstone of bone health, calcium has many extended benefits, and lowering blood pressure is one of them. When combined with magnesium, calcium plays a critical role when it comes to regulating the constriction and dilatation of blood vessels. 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. Previous studies have noted a reduction in systolic blood pressure as well as diastolic blood pressure per 100 mg of calcium consumed daily.”

On the website https://d-calusa.com/ FAQs page:

  • “How much calcium do I need if I suffer from osteopenia?...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.”
  • “Do I need calcium for hair growth?... 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.”

On the social media site at https://www.facebook.com/dcalusa/ which directs consumers to your website to https://d-calusa.com/ to purchase your products, including Chewable Calcium 600MG with Vitamin D for Kids in Orange Flavor:

  • Post dated June 28, 2021: “What happens if a child doesn't get enough vitamin D? 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…Follow us D-Cal for facts and tips about healthy lifestyles to stay strong!...#dcal#dcalkids”
  • Post dated June 25, 2021: “What happens if a child doesn't get enough calcium?...Kids who don't get enough calcium will have increased risk of bone fractures, not able to reach potential height, and osteoporosis later in life. Make sure your kids get enough calcium through meals or supplements! Follow us D-Cal for facts and tips about healthy lifestyles to stay strong!#dcal #dcalkids”
  • Post dated January 4, 2021: “Did you know vitamin D can help cut the risk of Covid-19? Remember to maintain a normal vitamin D intake level!...#covid19…#dcal…#dcalkids…”HOW VITAMIN D CUTSTHE RISK OF COVID-19…Covid-19 death rate by sunshine vitamin level…4.1% NORMAL***87.8%INSUFFICIENT…98.9% DEFICIENT...”

Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your product Chewable Calcium 600MG with Vitamin D for Kids in Orange Flavor is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, Chewable Calcium 600MG with Vitamin D for Kids in Orange Flavor fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433 or via email at Lillian.aveta@fda.hhs.gov (preferred). If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or email atLillian.aveta@fda.hhs.gov.

Sincerely,
/S/

Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1

 
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