Source: https://unapprovedpharmacy.com/2010/11/27/maxam-nutraceutics/
Timestamp: 2019-04-20 04:22:13+00:00

Document:
This letter concerns your firm’s marketing of your products: PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell, Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion, NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and the Heavy Metal Screening Test on your website, www.maxamlabs.com. These products are marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.
According to labeling, your products are intended to affect the structure or function of the body of man or other animals and/or intended to cure, mitigate, treat, or prevent disease conditions.
321(g)(1), because they 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, all of the above-listed products are “new drugs” as defined by section 201(P) of the Act, 21 U.S.C. § 321 (p), because they are 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 your above-listed products, without an approved application, violates these provisions of the Act.
Furthermore, your above-listed products are offered for conditions which are not amendable to self-diagnoses and treatment by individuals who are not medical practitioners such as, but not limited to, autism, Alzheimer’s disease, heavy metal toxicity, uterine fibroids, mood disorders, impotence, asthma, diabetes, and infections including herpes, HIV (human immunodeficiency virus), and EBV (Epstein-Barr virus). Therefore, adequate directions cannot be written so that laymen can use your products safely for their intended uses. Thus, the labeling of your above-listed products fail to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). The above~listed products are not exempt, under 21 C.F.R. §§ 201.100(c)(2) and 201.115, from the requirement that their labeling bear adequate directions for use because they lack approved applications. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act, 21 U.S.C. § 331(a).
In addition to the new drugs that you market and sell on your website, www.maxamlabs.com in violation of the Act, you also market and sell the Heavy Metal Screening Test in violation of the Act.
The Heavy Metal Screening Test is a device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. The Heavy Metal Screening Test, used to detect heavy metals in human urine, saliva and/or hair, 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 Heavy Metal Screen 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 products. 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.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action, without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
include the name of your supplier in addition to the manufacturer. Address your reply to the Food and Drug Administration, 22201 23rd Drive Southeast, Bothell, Washington 98021-4421, Attention: Lisa M. Althar, Compliance Officer.
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 20993-0002.
FDA Warning – AMAG Pharmaceuticals, Inc.
FDA why dont you take harmful drugs off the marcket like ciproflaxin and otber potentially harmful flouroquinalones.? why do you allow Flouride in our drinking water to prevent cavities that makes flouride a drug. because gets rid of cavity. and you put it in our drinking water I personally dont want you to put anything in my water thank you.
we the people should shut you down. why do you allow MSG in our foods. why do you allow canola oil. why do you allow GMO foods ect. ect ect.
its time for tax payers to stop paying your salaries remember we give you a job.
I had a terrible experience with the FDA approved anti biotic Levaquin. IT almost ruined me I had the runs for weeks and lost 15 lbs. Ever since that treatment I need to take probiotic daily. One of the products that helped me get this disaster under control was Maxam’s PCA RX. It helped me to get my bowles under some control and then the probiotics. Levaquin still has the blessing of the FDA. Maxam labs is being raided. Go figure,..
PCA-Rx help me and many other from death. I went to the hospital and they could not figure out what was wrong with me. I did thousands of hours of research and realized the Maxam Labs product called PCA-Rx would do what I need. Now I’m as healthy as a 20 year old.

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