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

May 11, 2010

OVERNIGHT MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 10-22

Dr. Leonard G. Horowitz
Healthy World Distributing, LLC
206 North 4th Avenue, Suite #147
Sandpoint, Idaho 83864

Jacqueline G. LindenBach
Mary Johnson
Healing Celebrations, LLC
217 Cedar Street, #326
Sandpoint, Idaho 83864

WARNING LETTER

Dear Dr. Horowitz, Ms. LindenBach and Ms. Johnson:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your integrated system of promotional websites and labeling for your "Oxysilver," "PrimoLife," "ZeoLife," "Green Harvest," "ElectrOEnyzmes," "OxySilver Immune Support Hydrosol Concentrate," "GI Flora Pro," "OxyAdvantage," and "Love Minerals" products. We have reviewed the internet addresses where these products are sold, www.oxysilver.com, www.healthyworldambassadors.com and www.healthyworldstore.com. and have determined that they are promoted for conditions that cause them to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].

The therapeutic claims on your websites establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease, and/or in the case of your products marketed for topical use, because they are intended to affect the structure or function of the human body. The marketing of your products with these claims violates section 505(a) of the Act [21 U.S.C. § 355(a)]. In addition, your products Oxysilver, Green Harvest, ElectrOEnzymes, and OxySilver Immune Support Hydrosol Concentrate 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)].

In addition, your websites listed below automatically redirect to www.oxysilver.com:

www.aquasilver.net, www.aquasilver.us, www.aguasilver.org, www.hydrosil.info,
www.hydrosilver.net, www.hydrosilver.us, www.hydrosol.org, www.hydrosolcures.com,
www.hydrosolcures.info, www.hydrosolcures.net, www.hydrosolcures.org,
www.hydrosolcures.us, www.hydroxysol.com, www.hydroxysol.net,
www.oxysilver.info, www.oxysilver.net, www.oxysilverclub.net,
www.oxysilvercure.com, www.oxysilvercure.info, www.oxysilvercure.net,
www.oxysilvercure.org, www.oxysilverhydrosolution.com,
www.oxysilverhydrosolution.info, www.oxysilverhydrosolution.net,
www.oxysilverhydrosolution.org, www.oxysilverimmunization.com,
www.oxysilverimmunization.info, www.oxysilverimmunization.net,
www.oxysilverimmunization.org, www.oxysolution.com, www.silveroxygenhydrosol.com,
www.silveroxygenhydrosol.info, www.silveroxygenhydrosol.net,
www.silveroxygenhydrosol.org, www.silveroxygenhydrosolution.com,
www.silveroxyhydrosol.com, www.silveroxyhydrosol.info, www.silveroxyhydrosol.org,
www.silveroxysolution.com, www.silveroxysolution.net, www.theoxysilverclub.com,
www.theoxysilverclub.info, www.theoxysilverclub.net, www.theoxysilverclub.org,
www.theoxysilvercure.com, www.theoxysilvercure.info, www.theoxysilvercure.net,
www.theoxysilvercure.org, and www.theoxysilvercure.us.

Also, your websites listed below promote Oxysilver with "buy" links or a graphic representation of Oxysilver that links directly to www.oxysilver.com:

www.fluscam.com, www.fluscam.tv, www.swinefluscam.info, www.love528tv.com,
www.healthyworldshop.com, www.love528.net, www.healthyworldsolutions.com,
www.alternativehealthcarenow.org, www.alternativehealthcarenow.com,
www.drleonardhorowitz.com, www.drhorowitz.info, www.lenin528.com,
www.natureslovingessence.com, www.natureslovingessence.info, and
www.natureslovingessence.net.

In addition, your websites listed below automatically redirect to the opening page of www.healthyworldstore.com:

www.hydrosonicevolution.info, www.hydrosonicevolution.net,
www.hydrosonicevolution.com, www.hydrosonicevolution.org, www.selfcaremall.com,
www.selfcarestore.net, www.selfhealthdepot.com, www.vibrate528.org,
www.vibrationalhealing.name, www.vibrationalmedicine.name, and
www.vibrationalmedicineonline.com.

1. Claims on www.oxysilver.com

The website address www.oxysilver.com appears on your Oxysilver product label. Examples of some of the claims observed on your www.oxysilver.com website include:

Oxysilver

The following are claims that stream at the top of your www.oxysilver.com home page:

Additional claims found on your www.oxysilver.com home page include:

The following claims are found on the page that opens from the "Technology" tab on the www.oxysilver.com home page:

Your www.oxysilver.com website also contains disease claims in the form of personal testimonials. These testimonials are examples of those found on the page that opens from the "Validation" tab on your home page:

The claims quoted above are supplemented by the metatags used to bring consumers to your www.oxysilver.com website through Internet searches. The metatags include:

In addition, the following claims in the form of personal testimonials marketing the OxySilver™ product for topical uses were found on the page that opens from the "Validation" tab on your www.oxysilver.com website:

When intended for topical use, Oxysilver is not a dietary supplement because the Act defines the term "dietary supplement" in 201(ff)(2)(A)(i) of the Food Drug and Cosmetic Act (21 U.S.C. § 321(ff)(2)(A)(i)), as a product that is "intended for ingestion." Topical products and products intended to enter the body directly through the skin or mucosal tissues are not dietary supplements. The above testimonials suggesting that consumers use Oxysilver topically subject the product to regulation as a drug. Thus, Oxysilver is a drug under 201(g)(1)(B)/(C) of the Act (21 U.S.C. §321(g)(1)(B)/(C)), because it is intended to affect the structure or function of the human body and/or to prevent, treat or cure disease conditions.

2. Claims on www.healthyworldambassadors.com

Examples of some of the claims observed on your www.healthyworldambassadors.com website include:

Oxysilver:

3. Claims on www.healthyworldstore.com

Examples of some of the claims observed on your website www.healthyworldstore.com include the following:

PrimoLife

"PrimoLife... possesses the secrets of living disease-free ... enhance your immune system's ability to identify and destroy germs and diseased cells."

2009 Flu Package Special (includes PrimoLife, Oxysilver, Zeolife, GI Flora Pro, OxyAdvantage, and Love Minerals)

Green Harvest

ElectrOEnzymes

Oxysilver Immune Support Hydrosol Concentrate

The claims quoted above are supplemented by the metatags used to bring consumers to your www.healthvworldstore.com website through Internet searches. The metatags include:

Your products OxySilver, PrimoLife, ZeoLife, Green Harvest, ElectrOEnzymes, OxySilver Immune Support Hydrosol Concentrate, GI Flora Pro, OxyAdvantage, and Love Minerals are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(P)]. Under section 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. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.

Furthermore, because your Oxysilver, Green Harvest, ElectrOEnyzmes, and OxySilver Immune Support Hydrosol Concentrate, products are offered for conditions that are not amenable to self diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layperson can use the products safely for their intended uses. Thus, their labeling fails 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 introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].

The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. Sections 302 and 304 of the Act authorize the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be directed to: Lisa Althar, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington, 98021-4421. If you have any questions regarding any issues in this letter, please contact Ms. Althar at (425) 483-4906.

Sincerely,

/s/

Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety and Applied Nutrition

Deborah Autor
Director
Office of Compliance
Center for Drug Evaluation and Research

Charles M. Breen C.
Director
Seattle District Office

This page was posted on May 28, 2011.

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