Herbal Science International, Inc. Recalls 12 Dietary Herbal Supplements

Herbal Science International, Inc. is recalling 12 dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers.

The U.S. Food and Drug Administration (FDA) regards dietary supplements containing ephedra as potential health hazards because this botanical contains ephedrine alkaloids. 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. Based on this and other evidence in the scientific literature, the FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.

The company is recalling nine products that contain ephedra, a source of ephedrine alkaloids, as an ingredient sold labeled under the following brands: 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 and Fang Feng Tong Sheng San.

Herbal Science International, Inc. is also recalling Tou Tong San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo Joint Relief), two products containing aristolochic acid. 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.

Lastly, 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 United States.

All of the 12 products under voluntary recall are packed in white plastic bottles of 100 capsules. All lots are covered in this recall action. These products have been sold nationwide in herbal stores, by acupuncturists and on the Internet.

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 healthcare professional.

Herbal Science International, Inc. apologized for any inconvenience and expressed its concerns for the health of consumers by conducting a voluntary recall action. Herbal Science International, Inc. promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.

Comments

[Barney]

Another example of why the Dietary Supplement Health and Education Act of 1994 is a bad law. In an ideal world all OTC, herbal, pharmaceutical preparations would be monitored by the FDA, but they just do not have the resources for them to handle it all. Even prescription drugs are not free from mistakes either, with the latest example being impure heparin preparations that were manufactured improperly in Chinese facilities. Unfortunately, consumers will have to live with the inability of the government to protect them and rely and trust manufacturers to do the right thing and perform their own recalls. In this case of Herbal Science International Inc. they did the right thing, but how many manufacturers that are trying to make a buck will do the same?

[Kara]

Yikes. I feel like I'm constantly hearing about recalls of herbs and supplements. I don't understand why the FDA doesn't do something to change the way herbs/supps are regulated. Everyone always says they don't have enough resources, but this has been an ongoing problem for many years. I would think that by now they would have passed some new legislation and expanded their organization.

[Jane]

It's stories like this that make me reluctant to try herbal supplements. Knowing that there are potential interactions, side effects and contaminations and that the FDA does not regulate these products as strictly as drugs makes me uneasy. I won't really feel comfortable trying supplements until I feel confident in the way they're regulated. I know that even the drug industry has its flaws, and there are recalls from time to time. I'm not looking for perfection. Just a little more reassurance that what I'm taking isn't going to harm me.

[Melinda]

It's good that Herbal Science International, Inc. is taking action to ensure their consumers are safe. However, it's unfortunate that we have to rely on the manufacturer's conscience rather than the law.

[Carrie]

Why were these products even marketed in the first place? It's not like they were accidentally contaminated with something harmful. The manufacturers chose to use ingredients that were known to be illegal in the United States. I'm glad these products are finally off the market, but they never should have been sold in the first place.

[Betty]

Ephedrine, aristolochic acid and human placenta can all cause serious health problems. Did anyone become ill after using their products? What prompted Herbal Science International to issue the recall?

[Joe]

After reading this, I still feel safe in taking dietary supplements. This was a voluntary recall that the manufacturer was not obligated to perform. Herbal Science International Inc. has taken the proper steps in notifying the public to rectify the situation. I think that this mirrors the lead content in toys and mad cow disease in beef incidents. There is an initial uproar even though the scope of the recall is minuscule when compared to the industry as a whole. It would be impossible for regulatory agencies to keep all of these products 100% safe all of the time. As consumers, we must trust that the manufacturers will self regulate themselves and recall products when it is necessary.

[DC]

While much is left to the manufacturer regarding the quality of dietary supplements, there are still safeguards in place for the consumer. USP and NSF require dietary supplements to undergo rigid quality assurance testing, and I don’t believe a product containing ephedra alkaloids or aristolochic acid would receive an approval seal. The problem remains that the everyday consumer is unaware of what these verification seals entail and many may think it’s simply a gimmick to sell more product. Is anyone aware who initially sparked this recall - the company itself or an outside source?

[LM]

It is unfortunate that manufacturers of herbal products and dietary supplements are not monitored by the FDA. More and more consumers are turning to CAM therapy, and regulation in this industry is necessary. Manufactures, such as Herbal Science International, Inc., are conscious enough to recall potentially harmful products, but what about other manufacturers that may not be as conscious? It is important that both consumers and healthcare professionals become educated and know how and where to find reputable herbal products.

[TJ]

Does the government plan on regulating herbs and supplements more strictly in the future, or are they always going to use the excuse that they don't have enough resources?

[Lynn]

Wow. There have been so many recalls from Chinese products lately. Was there an issue with these products because China and the United States have different requirements?

[Lily]

Seng Jong Tzu Tong Tan contained human placenta? Why would that even be in their product to begin with? It sounds very gross to me.

[DC]

Lynn, it's not so much that the products are "Chinese" because Herbal Science Int' is a company that was initially founded in Los Angeles. The problem is what many have alluded to; that the FDA does not have strict enough regulations on these herbal and dietary supplements. I can't seem to locate a resource stating how this information initially made it to the FDA. However, in regards to ALL dietary supplements, whether made inside or outside the USA, there has to be some regulation put in place. It has been a while since I looked at the data, but I remember seeing somewhere the large list of contaminants (including lead and arsenic I believe) in many of the products. Seals of approval, at the VERY least, should become standard in order to sell these products. The USP, NSF and NPA will all certify products under rigorous standards. Certainly a product like the ones from Herbal Science Int' recall would not make it through (and likely I would hope be reported to the FDA). Many of the products sold in chain community pharmacies bear these seals.

On a separate note, I tried to locate some information on just why a human placenta would be put into a product. In answer to your question Lily, there is no good reason. I found very anecdotal advice stating it contained a high amount of nutrients and minerals, as well as hormones like oxytocin, and possibly "preventing post-mortem depression," but I can't imagine any of this being clinically relevant. It would take a lot of nutrients, vitamins, minerals, hormones (anything), over quite a bit of time to have a meaningful effect. Whereas on the other hand, it will only take a tiny amount of bacterial contaminant (in an anatomical part with one function being to filter "waste") to cause a serious infection. The real question Herbal Science Int' needs to be asked right now is...where are you getting your human placentas to begin with?

[mo]

The take-home message here is that consumers (even those knowledgeable about dietary supplements) don’t understand how products are (or are not) regulated. I found a neat little book with a great section on what the Dietary Supplement Health and Education Act (DSHEA) does and does not cover. It’s called “Understanding Dietary Supplements,” and it’s written by a registered dietitian:
http://www.amazon.com/Understanding-Dietary-Supplements-Health-Sickness/dp/1578069815/ref=sr_1_12?ie=UTF8&s=books&qid=1209159596&sr=8-12

[Larry]

The use of human placenta in a product does not surprise me at all. Many cultures and other countries use placenta from various sources as an alternative treatment for a wide variety of ailments. The majority of evidence is anecdotal and based on tradition, but how many popular herbs used in the U.S. aren’t? The thing that scares me is the other ingredients could be in there like lead, arsenic, etc., as other people have pointed out. Homegrown herbs seems like the only way to go.

[Elvien]

In this site we can find scientific information about herbs, their use during pregnancy and many other things
http://herbalinformation.awardspace.com

[Denise]

Meanwhile, the FDA recently issued a warning that some red yeast rice supplements may contain a potentially harmful prescription drug called lovastatin.

[Em]

I was also shocked to see that human placenta was found.

I did some digging online: "Placenta hominis, generally substituted with canine or porcine placenta today, is a traditional source of hormones, amino acids and enzymes. Examples include human gonadopin, oxytoncin, prolactin, TSH and sex hormones."

It has been studied as a possible treatment for chronic tracheitis (IM), asthma and lung cancer (believe it or not). It is traditionally used to treat children with underdeveloped sex organs.

[Jess]

I still think it's unfortunate that ephedra is banned in the United States, as this plant has had much good use in the past for asthma and bronchoconstriction. Of course, there are safety concerns here, but I find it very strange that places in Asia have found a way to use these preparations effectively and the United States has not. Are the herbs dangerous, or are we a culture of misuse and abuse?

[Leah Cohen]

To Em's point above, yes, ephedra was traditionally used for asthmatic bronchoconstriction, and nothing else. Not for weight loss, not for increased stamina, etc. Any reputable integrative practitioner would never recommend ephedra for weight loss or for anything other than bronchoconstriction, which could not be treated with other therapies/herbs.

Also, the safety concerns of herbs and supplements imported from other countries, for instance China, cannot be understated. It is up to the general population to be informed of these concerns and to demand quality supplements from their local suppliers, health food stores, practitioners, etc. All herbs/supplements should be organic, and all ingredients should be clearly stated in English, with both common and Latin names indicated on the label, so it is very clear what is contained in the product. I would say that if a product falls short of this, caution is to be exercised, and consultation with a healthcare provider is essential.

[x-ray fluorescence]

Very nice information. Many cultures and other countries use placenta from various sources as an alternative treatment for a wide variety of ailments. The majority of evidence is anecdotal and based on tradition.