What’s in a name? “Natural” and “science” doesn’t mean safe
One year ago, the April fools’ post on diet wackiness included a serious discussion of potentially dangerous substances being found in natural weight loss supplements. The FDA and health agencies around the world were especially concerned about one ingredient, aristolochic acid, due to growing reports of kidney toxicity and failure, and carcinogenicity.
The FDA just issued a notice that Herbal Science International, Inc. (aka Jen-On Herbal Science International, Inc.) has recalled 12 supplements for containing ephedra, artistolochic acid or human placenta, because of their serious health risks for consumers.
According to the recall notice*, the following products were recalled for containing ephedra:
Wu Yao Shun Qi San
Qing Bi Tang (Nasal Cleanser)
Zhong Fong Huo Luo Wan (Stroke Revito Formula)
Xiao Qing Long Tang (Little Green Dragon)
Ding Chuan Tang
Xiao Xu Ming Tang
Feng Shi Zhi Tong Wan (Joint Relief)
Guo Min Bi Yan Wan
Fang Feng Tong Sheng San
“Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Recent studies have confirmed that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system, effects that are linked to adverse health effects like heart attacks and strokes,” said the FDA.
Also recalled are two products containing aristolochic acid:
Tou Tong San (Headache Formula)
Du Huo Ji Sheng Tang (Du Huo Joint Relief)
“Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. This chemical can cause serious kidney damage and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure. These products have also been linked to an increased risk of kidney cancer in people who have consumed them,” said the FDA. [More information here. The FDA Aristolochic acid page of documents is here.]
Finally, the company is recalling Seng Jong Tzu Tong Tan, a product that contains human placenta. “Human placenta may transmit disease and dietary supplements that contain it may not be lawfully marketed in the
The FDA advises:
Consumers who have purchased these products should immediately discontinue their use and return them to the place of purchase for a full refund. Consumers with questions may contact the company at (626) 333-9998. Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals can also report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.
The company, Jen-On Herbal Science International, Inc. had also issued a recall notice last April for a supplement sold for erectile dysfunction that contained an analog of the pharmaceutical drug, Vardenafil, which could endanger consumers due to interaction with nitrates and drop blood pressure to dangerous levels.
In other supplement news, just two days ago, the FDA announced that U.S. Marshals had seized more than 14,000 doses of natural supplements, being marketed for erectile dysfunction, that contained undeclared drugs that could have serious side effects with medications men could already be taking. The FDA had issued a warning letter to the company, which the company had disregarded.
And last week, at the request of the FDA, federal marshalls seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, for natural supplements again being marketed to body builders that were also found to contain undeclared ingredients.
* The date is incorrect as originally posted on the FDA website. Ginger Chang, company spokesperson for Herbal Science International, Inc., confirmed that the recall was just issued and the correct date should read April 10, 2008.