A lot has happened since 1994 when the FDA decided to let “their hair down” and deregulate the Herbal Supplement Industry at the pleas of “naturalists” who demanded that the government and pharmaceutical industry were in a conspiracy to keep these less costly “natural products” out of the hands of the consumer.

As herbal supplements became the new “drug of choice”, offering lower costs and “safe” natural alternatives to pharmaceuticals demand skyrocketed and the industry became rife with opportunities for profit and exploitation. It is clear that, as with other industries, recognizing the problems with allowing an industry to “self regulate” might be equated to letting the fox in the henhouse and being surprised when the chickens are gone. According to a new report filed by Global Industry Analysts Inc.

We reasonably believe that a product label describes the ingredients actually contained in the product and that a certain standard of quality control exists to ensure purity and safety. We reasonably assume that natural means safe and consumers have generally been willing to pay for the promise of good health or a remedy to a condition.

Unfortunately, the media does not give enough attention to stories such as: “PhD student dies after using Chinese herbal medicine to cure upset stomach”.  Reports of herbal supplement related poisoning, toxicity and contamination have risen more than 344% since 1994 however this has not gone unnoticed by the FDA.

New government regulations by the FDA are being implemented that will require manufacturers to evaluate the identity, purity, strength, and composition of their products.

“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

The establishment of GMP’s within the Herbal Supplement industry just as regulated in pharmaceuticals are key to product safety and purity.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition. In addition the FDA will now require “CGMPs to apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S. “To limit any disruption for dietary supplements produced by small businesses, the rule has a staggered three-year phase-in for small businesses. The final CGMPs is effective in June 2008 for large companies. Companies with less than 500 employees have until June 2009 and companies with fewer than 20 employees have until June 2010 to comply with the regulations. Benefits to consumers are to “ensure access to dietary supplements that meet quality standards and that are free from contamination and are accurately labeled as to identity purity and strength.”

Mayo Clinic however advises in a November 2007 article that, even with the FDA responsibility for monitoring the safety of supplements there are still potential risks posed by herbal supplements.

Mayo clinic recommends the following when choosing a herbal or dietary supplement to protect yourself against possible contaminated or toxic products:

Look for standardized herbal supplements. The U.S. Pharmacopeia’s “USP Dietary Supplement Verified” seal on a supplement indicates the supplement has met certain manufacturing standards. These standards include testing the product for uniformity, cleanliness and freedom from environmental contaminants, such as lead, mercury or drugs. Other groups that certify herbal supplements include ConsumerLab.com, Good Housekeeping and NSF International. Although each group takes a slightly different approach, the goal of each is to certify that herbal supplements meet a certain standard. Don’t assume that all herbal products on the market are safe. Even the groups that test herbal supplements aren’t obligated to report products that fail to live up to their standards.

Buy only single-herb products. And choose products that clearly show how much of the herb each dose contains. Some products are mixtures of several herbs with unknown proportions of each.

Beware of claims that sound too good to be true. If a claim sounds outrageous to you, trust your instinct. No one herbal supplement can possibly address a wide spectrum of health concerns.

Be extremely cautious about herbal supplements manufactured outside the United States. Many European herbs are highly regulated and standardized. But toxic ingredients and prescription drugs have been found in some herbal supplements manufactured in other countries.

You’re taking prescription or over-the-counter (OTC) medications. Some herbs can cause serious side effects when mixed with prescription and OTC drugs such as aspirin, blood thinners or blood pressure medications. Talk to your doctor about possible interactions.

A proven medical treatment is available for your medical condition. A traditional medication with an established record for safety and effectiveness will generally be less likely to result in adverse side effects.

You’re pregnant or breast-feeding. As a general rule, don’t take any medications — prescription, OTC or herbal — when you’re pregnant or breast-feeding unless your doctor approves. Medications that may be safe for you as an adult may be harmful to your fetus or your breast-feeding infant.

You’re having surgery. Many herbal supplements can affect the success of surgery. Some may decrease the effectiveness of anesthetics or cause dangerous complications, such as bleeding or high blood pressure. Tell your doctor about any herbs you’re taking or considering taking as soon as you know you need surgery.

You’re younger than 18 or older than 65. Older adults may metabolize medications differently. And few herbal supplements have been tested on children or have established safe doses for children.

 

 

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This entry was posted on Wednesday, May 21st, 2008 at 2:37 pm and is filed under Mass Torts, Product Liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.