The U.S. Food and Drug Administration and the Ephedra Ban Hoax

Nature’s Sunshine Products, December 31, 2003

US Government Bans Ephedra

On Tuesday, December 30, 2003, federal officials announced their intention to ban all ephedra-containing products in the U.S. Nature's Sunshine will comply with this ban by removing all ephedra products (listed below) from our warehouses when restrictions are finalized.

Nature’s Sunshine’s Tradition of Quality and Safety

Nature’s Sunshine’s history with ephedra-containing products is untarnished; all products have been carefully formulated and tested, and have always included appropriate safety warnings. We are one of the few companies to refuse to include caffeine in any of our ephedra formulas. It is unfortunate that many of our competitors have contributed to this ban by irresponsibly selling unsafe ephedra combinations. Over the years thousands upon thousands of satisfied customers have purchased and re-purchased NSP’s ephedra formulas, with countless success stories shared. These products have not only proved to be used safely, but have also been very effective. Please see the “NSP Ephedra Statement” below for our view on this issue.

Ephedra Products and Their Alternatives

[The original policy statement from Nature’s Sunshine included a list of all ephedra-containing products and their replacement products. Subsequently, both Nature’s Sunshine and Pure Herbs have reformulated all of their herbal combinations to utilize Bitter Orange as an acceptable replacement for ephedra.]

Thank you for sharing our commitment to safe, natural healing.

Ephedra Frequently Asked Questions

Is it legal to possess ephedra products after the ban is imposed?
Yes, for personal consumption. However, you may not re-sell them.

What is the shelf-life for these products?
They should be safe and effective for no less than two years following delivery.

Will ephedra ever be available again?
In the short-run, this is not likely. Ephedra has become a very emotional and political issue. In the long-term, it is not impossible for a ban like this to be lifted.

What can I do to protect my natural health rights?
NSP is affiliated with several natural health organizations, including their sponsorship of the Health Freedom Fund. To learn how to get involved, contact the National Health Freedom Coalition at www.NationalHealthFreedom.com.

NSP Ephedra Statement

Nature’s Sunshine Products, December 2003

Ephedra, also known as Ma Huang or Chinese ephedra, is a plant that grows wild in arid areas of the world. Many species of ephedra exist, and most of these contain a mixture of active compounds known as ephedrine alkaloids.

On Tuesday, December 30, 2003, the FDA announced that it will ban the sale of ephedra-containing dietary supplements in approximately 60 days, and advised consumers to stop using ephedra-based products. This announcement did not come as a surprise to Nature’s Sunshine Products (NSP), as we follow the scientific and regulatory community closely and aggressively communicate our position. In fact, this likelihood was one of the catalysts for the development of our recently formulated ephedra-free (EF) products, including MetaboMax EF and MetaboStart EF.

Though we are required to comply with this ban, we will continue to sell our ephedra-based products until the ban takes effect, and while supplies last. Why? We believe that ephedra is safe and effective when taken according to label recommendations. Ephedra herb contains a mixture of ephedrine alkaloids, and a dose of 12 mg of these alkaloids up to three times daily is considered safe for healthy individuals within specific parameters clearly described on our labels. This is the dose NSP recommends and is the dose that hundreds of thousands of NSP customers have used safely. This is also similar to doses that have been used in China for 5,000 years. Furthermore, NSP and the FDA both monitor complaints or “adverse events” due to our ephedra-containing products. In the more than 12 years that NSP has offered ephedra-based formulas there have been zero deaths and only a handful of minor customer complaints that could have any relation to ephedra--in spite of the fact that this time period represents hundreds of thousands of users and literally millions and millions of doses.

It saddens us that U.S. consumers no longer have the option of using this naturally occurring nutritional supplement for respiratory support or weight management.

Why did the FDA target ephedra?

The FDA has received complaints regarding adverse effects of ephedra products. However, when these complaints were reviewed, two things stand out: often, the products were used improperly; and, rarely were the adverse events linked solely to ephedra. Many manufacturers formulate their ephedra products to include natural sources of caffeine (kola, green tea, guarana, etc.). Nature's Sunshine's position has been that caffeine should never be combined with ephedra. Some manufacturers go further and simply spike their ephedra product with caffeine. It is unfortunate that none of the “analysis” performed by these agencies has examined the difference between companies who responsibly formulate with ephedra, and those who don’t.

Further, this ban only affects natural health companies. Ephedrine alkaloids include ephedrine, pseudoephedrine, methylephedrine, norephedrine, and others. Synthetic versions of these chemicals can be found in over-the-counter (OTC) products. For instance Sudafed® is synthetic pseudoephedrine. Other synthetic ephedrine derivatives can be purchased at retail outlets such as gas stations. In effect, the FDA didn’t ban the active ingredients in ephedra, they just banned the nutritional supplement industry from selling the ephedra herb. Consumers can still obtain synthetic versions of the ephedrine alkaloids as OTC products.

NSP firmly believes in the health benefits of natural ephedra. We believe ephedra has had a strong impact on consumers’ health, among others providing natural relief for asthmatics and in cases of respiratory congestion. We also believe that obesity has become an epidemic in the U.S. and should be addressed through diet, exercise and the careful use of natural products. NSP customers have had great success with ephedra products without serious adverse events. We believe that the people-to-people health business has allowed our members to educate consumers on the safety, efficacy and proper use of ephedra products.

We will comply with this new FDA regulation and urge you to do the same. We also suggest you write your representatives in Congress and let them know how you feel to have this choice taken away from you.

Nature’s Sunshine Products
Health Sciences

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