Handelnine Global, LLC dba Navafresh

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your Navafresh products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Passage 2

No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs.

Passage 3

the labeling of your unapproved “Dr. Patels Measles Tablets,” “Mans-Pachak Vati,” “Adel-54 Heart Care Drops,” “Ayuvardhak Sutta Yog,” “Parkikyor Tablets,” and “Tri-Origin Ayurveda Diabetic Tablets” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as cancer, diabetes, and measles

Passage 4

your “Rheumacare Capsules” product is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is dangerous to health when used in the dosage or manner recommended in the labeling.

Passage 5

The labeling for your “Rheumacare Capsules” product does not declare that the product contains lead, which is a material fact with respect to consequences that may result from the use of this product.

Passage 6

FDA laboratory testing of “Rheumacare Capsules” lot CAM040 and lot CAL079-N found unsafe levels of lead contamination. The individual sample results varied between 9,588ppm and 11,124ppm.

Passage 7

As a result of excessive lead content, your “Rheumacare Capsules” are adulterated under section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B) because the presence of such substances in the amounts identified by FDA demonstrates that the product has not been manufactured and processed in a manner that conforms to CGMP requirements.