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Rediscover
Yourself, Feel Great Again, Naturally!
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Our Natural Progesterone
Cream Formula can help with the following:
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These products and these statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. Consult a health care professional before using these or any product during pregnancy or if you have a serious medical condition. Comments on FDA Issues The FDA has a regulation that requires a statement similar to, or identical to the one above, be included on all nutritional product labels and literature. Some nutritional products are known to prevent or cure diseases. Manufacturers of such products, however, are not permitted to make such claims unless the product in question has been subjected to the same FDA-supervised rigorous multi-million dollar trials and tests that apply to drug companies for their products. The primary function of drug companies is to research, develop and manufacture patentable synthetic drugs. Patents protect profits, which in turn is what justifies the millions of dollars that are spent on trials and testing. Patent protection is not available for products that occur in nature or products that are naturally available. A "use patent" is occasionally allowed on natural products, but a use patent does not prevent other companies from manufacturing the same products. Exclusive profit protection on natural products is difficult or impossible. In the absence of protection to ensure exclusive rights to a product, nutritional companies cannot afford to spend the millions of dollars necessary to obtain FDA approval. Hence, nutritional companies rely on evidence which is usually anecdotal, historical or based on studies and research which, hopefully, are valid and authoritative - but are usually not in compliance with the more costly FDA regulations that apply to drugs. Is the Nutritional Industry Regulated? According to the commissioner of the FDA, Dr. Henly, the FDA reported to Congress that it has all the power it needs to regulate the nutrition industry. Over the years, there have been a number of notable actions taken by the FDA that have given the appearance that they favor drug companies over the nutritional industry. One type of action the FDA has occasionally taken is to remove from the market a product line (based on natural ingredients) that competes against a previously approved drug. There have been at least two recent court decisions that have favored the nutritional industry when such action has been taken. Hopefully the FDA will be less inclined to take good natural products off the market in the future. In 1994, Congress enacted DHSEA (Dietary Health Education Act) which amongst other things defined what type of statements the nutritional industry is permitted to state about its products. DHSEA defined and established the fine line between a serious disease or drug claim and the more general structure/function claim. Under FDA regulations, the difference between a drug and dietary supplement is determined not by the ingredients, but rather by the claims that are made on the label. Under the regulations, the FDA, for example, would classify vitamin C as a drug if the label had serious disease claims such as the claim that it treated cancer. The FDA would then not approve the drug unless the company making the claim had undertaken rigorous and expensive FDA-supervised trials and testing that are required for drugs. (Vitamin C is known to prevent cancer by shielding DNA from free radical damage.) Certain types of nutrients (vitamins, etc.) have been shown, in research, to prevent and even cure serious diseases. Prior to DHSEA, the FDA would not allow any such claims to be made for nutritional products and it was difficult, if not impossible, for manufacturers of such nutrients to legally explain to consumers the benefit of taking such supplements. DHSEA was enacted by Congress to help the nutritional industry educate the public about the benefits of their products. Under the DHSEA regulations, nutritional companies are permitted to make what has become known as structure/function claims about their products. For example, certain types of natural vitamin E have been shown in research to help prevent and even help cure problems relating to heart disease. While natural vitamin E may be helpful to heart disease, a manufacturer of a vitamin E cannot legally say that their vitamin E helps prevent or cure heart disease. Under DHSEA regulations, however, they can say that vitamin E may be helpful to the cardiovascular systems. Another example is that Cetyl Myristoleate, combined with Glucosamine and Sea Cucumber, has been shown to cure some types of arthritis. Under DHSEA, the nutritional companies are only able to say that these products may help the joints and cartilage. They cannot mention the word "arthritis" in relation to their products. DHSEA does allow the distribution of information and articles to consumers providing the information is published, is scientific, is balanced and providing the article does not promote a particular brand of product. The DHSEA regulations have helped both the nutrition industry and the consumer when it established a fine line between a serious disease claim and structure/function claim. Under DHSEA, consumers are being provided with more information than was legally possible previously. Nevertheless, due to the difficulty in determining where the line should be drawn when describing product benefits, consumers are required to "read between the lines" when reviewing labels on products and related literature. Additional information on natural cures and remedies can usually be found in nutritional publications, books, and of course from medical practitioners who practice nutrition and alternative or complimentary medicine. Natural Pause
1 888 267-5032 Fax 1 877 368 8969 8665 W. Flamingo Road, Suite 131-413 Las Vegas, NV 89147 All rights reserved - Natural Pause
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