Newsletter Notes by David Winston, AHG

January 2004

FDA Ephedra ban — What does it mean for you?

FDA had announced its first ban of a dietary supplement. They will ban “dietary supplements containing ephedrine alkaloids. NOTE: the agency’s Consumer Alert used the word ephedra rather than ephedrine alkaloids but it appears as if the rule will focus on the presence of alkaloids; they specifically identified other plants known to contain ephedrine (e.g., Sida cordifolia; pinellia)

Exemption for certain products: In their “questions and answers” document the FDA stated, “The rule does not pertain to traditional Chinese herbal remedies. It generally doesn't apply to products like herbal teas that are regulated as conventional foods.&rdqo;

Ephedra or Ma Huang (Ephedra sinica) has been used responsibly in China for over 5000 years for treating wind-cold conditions.

While we as a traditional herbal company have never made weight loss or energy products from Ephedra and don’t agree with the use of such products without a practitioner’s supervision, we think the ban is based more on hysteria than on sound science. The BIG Question is what could be next??? Keep up to date on the shifting political issues

Echinacea—Does it work?

A recent negative study (Taylor, Weber, W., et al, Efficacy and Safety of Echinacea in Treating Upper Respiratory Tract Infections in Children: A Randomized Controlled Trial, J. Amer. Med. Assn. Dec. 3, 2003:290(21):2824-30) on the use of Echinacea for upper respiratory tract infections in children has been widely reported in the media.  This study is a good example of the need to read the entire study, not a review or abstract; and it also shows how the media can misrepresent a study to fit their own views. Headlines widely pronounced Echinacea Doesn't Work.  Let's look a little deeper and find the truth.  The study was conducted on 524 children ages 2-11.  The study did not show any significant difference between children taking the Echinacea product and placebo when it came to the duration or severity of symptoms for upper respiratory tract infections.

However, an important secondary outcome that was unreported by the media was there was a significant reduction in secondary and tertiary upper respiratory tract infections in the Echinacea group as contrasted with the placebo group. The second problem with this study, which is not clearly defined in the media reports, is the product used was a fresh juice extract of the above ground parts of Echinacea. This product is made in a 1:11 dilution.  In comparison, Herbalist & Alchemist's products are made from the roots or roots and cones and they are in a dilution of 1-2.5-meaning it is more than 4 times more concentrated than the German product that was used in the study.

The significance of these two findings shows that the Echinacea product studied, while not dramatically effective, actually did have some benefit dealing with children's respiratory tract infections and if researchers had used a more concentrated product in a higher dosage level they might have actually found what every herbalist and many parents in the U.S. know—that Echinacea is very useful for treating colds, upper respiratory tract infections, and even influenza.