Source: https://unapprovedpharmacy.com/2010/11/27/hormonal-health/
Timestamp: 2019-04-20 04:47:40+00:00

Document:
This product is marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.
Your firm markets Kelatox as a dietary supplement. Because this product is a suppository and not intended for ingestion, it is not a dietary supplement as defined by section 201(ff) of the Act, 21 U.S.C. § 321(ff). Rather, this product is a drug, as defined by section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1), because it is intended to affect the structure or function of the body and/or intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man.
Moreover, Kelatox is a “new drug” as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Kelatox suppositories without an approved application violates these provisions of the Act.
Furthermore, Kelatox is offered for conditions such as, but not limited to, lead poisoning, Alzheimer’s disease, autism, endothelial dysfunction, Parkinson’s disease, macular degeneration, and peripheral neuropathy, which are not amendable to self-diagnoses and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use Kelatox safely for its intended uses. Thus, the labeling of Kelatox suppositories fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). Kelatox is not exempt, under 21 C.F.R. §§ 201.100(c)(2) and 201.115, from the requirement that its labeling bear adequate directions for use because Kelatox lacks an approved application. 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).
The METALDETECTOR Instant Toxic Metals Test, used to detect heavy metals in human urine, is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. §351(f)(1)(B), because an approved application for premarket approval (PMA) pursuant to section 515(a) of the Act, 21 U.S.C. §360e(a) or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. §360j(g), are not in effect for it. The METALDETECTOR Instant Toxic Metals Test is also misbranded under section 502(o) of the Act, 21 U.S.C. §352(o), in that it was manufactured, prepared, propagated, compounded or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. §360; not included in a list required by 510(j), 21 U.S.C. §360(j); and notification or other information respecting the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. §360(k).
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above 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 and FDA regulations.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
A description of the new drug approval process can be found on FDA’s internet website athttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm. In addition, information regarding approval or clearance for devices is described athttp://www.fda.gov/cdrh/devadvice/3122.html. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO51-2201, Silver Spring, Maryland 20993.

References: § 321
 § 321
 § 321
 § 352
 §331
 §351
 §360
 §360
 §352
 §360
 §360
 §360