Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

October 12, 2010

VIA UPS

In reply refer to Warning Letter SEA 11-01


WARNING LETTER

James G. Cole, CEO

Maxam Nutraceutics/Maxam Laboratories

1020-D Wasco Street

Hood River, Oregon 97031

Re: 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

Dear Mr. Cole:

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.
Statements documenting these intended uses include, but are not limited to, the following:

PCA-Rx

PC3x

AD-Rx

AN-Rx (Pain Relief Anti-Anxiety Formula)

Anavone

AV·Rx

BioGuard

CF-Rx (Cellaflex Anti-Inflammatory Anti-Arthritic)

CreOcell (Creatinine Phosphokinase)

Dermatropin


"Dermatropin stimulates collagen, elastin regeneration, activates scar tissue repair, and reduces wrinkling and sun damage."


Endotropin

GTF-Rx (Glucose Tolerance Factor)

IM-Rx (Immune System Enhancement)

Keto-Plex

Natural Passion

NG-Rx (Neural Regeneration)

NX-Rx (Neural Enhancer)

OR-Rx (Osteo Regeneration Hard Tissue Support)

Oxy-Charge

PN-Rx (Pineal Stimulating Peptides)

Ultra-AV

Ultra Pure Yohimbe

Your firm markets the above-listed products as dietary supplements. However, your products are labeled as transmucosal sprays for sublingual administration. You also recommend that "It is also
beneficial to nebulize many of the Maxam products." In addition, your firm markets your products AV-Rx, BSAID, and CF-Rx for topical administration. Because these products are not intended for
ingestion, they are not dietary supplements as defined by section 201(ff) of the Act, 21 U.S.C. § 321(ff). Rather, these products are drugs, as defined by section 201(g)(1) of the Act, 21 U.S.C. §
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.

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 these products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please
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 at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm. In addition, information regarding approval or clearance for devices is described at http://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.


Sincerely,


/S/

Charles M. Breen

District Director

This page was posted on October 16, 2010.

Links to Recommended Companies