Our Natural Progesterone
Cream Formula can help with the following:
|
FDA Compliance
Natural Pause is dedicated to complying with
all FDA rules and regulations
increase the size of your breat with Beverly Hills Cosmetic Surgery Inc FDA Compliance Statement
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
11683 N. Noguera
Ventura, CA 93001
All rights reserved -
Natural Pause
|
