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

Public Health Service
Food and Drug Administration

 

Pacific Region
Seattle District
22201 23rd Dr SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

August 13, 2002
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Robert D. Harrison
President,
Earth & Plant, Inc
PO Box 1275
Homer, AK 99603

Ref. No. SEA 02-59

Dear Mr Harrison:

The Food and Drug Administration (FDA) inspected your firm located at 53135 McNeil Canyon Rd, Homer, AK, on May 30, 2002. Labeling for your firm's product Hydroxygen Plus indicates serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and the food and dietary supplement labeling regulations on the Internet through links on FDA's web page www.fda.gov.

This letter is to advise you of our inspectional findings and the findings of our review of your labeling for the dietary supplement Hydroxygen Plus including your website www.gethealthyagain.com. Labeling is not limited to the immediate product container but, as defined in Section 201(m) of the Act, includes all promotional material you distribute in connection with your products.

On your website, under the heading "Natural Immune Support for Lupus," you make the following claims for Hydroxygen Plus.

These statements cause your product to be misbranded under Section 403(a)( 1) of the Act. The available scientific evidence does not support the claims you are making for this product. The statements are, therefore, false or misleading and their use in labeling misbrands the product.

These statements also cause your product to be a drug as defined in Section 201(g)(1)(B) of the Act. Because we are unaware of any evidence that this product is generally recognized as safe and effective when used as labeled, it also is a new drug under Section 201(p) of the Act. Under Section 505 of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application.

The product is further misbranded under Section 502(f)(1) of the Act, in that it fails to bear adequate directions for use, and under Section 502(a) of the Act, in that the labeling is false and misleading because it suggests that the product is effective for its intended use. Efficacy for your product has not been established.

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. Other violations can subject the product to legal action. We note there are other labeling violations with other products that we have not included in this letter. It is your responsibility to assure that all of your products are labeled in compliance with the Act and regulations enforced by FDA.

We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement actions without further notice. These actions include seizure and/or obtaining a court injunction against further marketing of your products.

Please respond in writing within three (3) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. If you cannot complete all corrections before you respond, we expect you will explain the reason for your delay and state the time at which corrections will be completed.

Please send your reply to the Food and Drug Administration, Attn: Lisa M. Althar, Compliance Officer, 22201 23rd Dr SE, Bothell, WA 98021-4421.

Sincerely
/s/
Charles M. Breen
District Director

This page was posted on May 4, 2006.

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