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Servicing International Customers
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Book by Dr. David Wheeler
(Chiropractic Physician)
Water Empowerment For Life

FDA Disclaimer
Reseller Policy Notice


Good Manufacturing Practices

In the United States, the Food and Drug Administration requires GMP for both dietary supplements and food products. All of our natural supplements are in the food category and not in the dietary supplement category. Homeopathic products are an entirely different category with different FDA requirements.

Food products do not include the standard FDA disclaimer that is required for dietary supplements, which is the reason this disclaimer is not found on the labels for any of our products on anywhere on our websites. There is a standard disclaimer presented for homeopathic products, with more on the way in terms of research and development of new products for 2011.

While many businesses selling natural supplements online are resellers for manufacturers, this is not the case for any of our natural products. With a few exceptions, each product and technology presented on our website and other publications have been researched, developed, and produced by Health Breakthroughs International LLC.

The Health Breakthroughs International production facility was constructed in order to bottle a variety of different natural supplements. These facilities have been inspected and licensed by the state of Oregon as well as registered with the United States Food and Drug Administration. Our production facility is licensed in the state of Oregon for the bottling of water, which includes a much more stringent and detailed set of standards than those without the water bottling capability.

GMP simply means that a product is bottled according to a set of practices regulated at both the state and federal level. However, to make it somewhat confusing, there is no private or government authority that provides GMP certification. As a comparison, organic produce is inspected by a private, non profit organization that is recognized at both a state and federal level. There is no such private organization recognized by state or federal governments when it comes to certifying GMP.

A few private organizations have popped up that claim to inspect and certify GMP at bottling facilities for a very hefty fee, but these private organizations are not recognized by the FDA or any other agency at a state or federal level. Although some companies claim to be GMP certified, this representation is misleading because the government does not certify companies and the government does not recognize any private company or organization for being able to certify for GMP.

At Health Breakthroughs International LLC, we accomplish GMP in two different ways: 1) The state of Oregon and the United States Food and Drug Administration publish all the GMP requirements that any company can access online in order to comply and 2) We use Emord and Associates, with their central offices in Virginia, and a law firm specializing in FDA and FTC legal issues to inspect and guide my business in order to insure compliance with GMP and all areas in the regulatory environment.

On this page you can view some of the production areas that were built for manufacturing. These production areas are currently in full operation. Please feel free to contact our staff with any questions about GMP, our products, and how they are manufactured.

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GMP: Health Breakthroughs International products are made according to Good Manufacturing Practices
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