What do people think?
I don't think my opinion is really of any value, since I have no clinical expertise in medicine or pharmacy. When it comes to matters of health, I try to seek the strongest sources of evidence where it may correspond to the opinions of licensed health care professionals. I think anecdotal evidence provided by myself and others in online forums may be useful, but only as they may correspond with the evidence. Expert opinion can be valuable as well, but I recall not too long ago it seemed several individuals in this forum were convinced a particular individual was a licensed physician, when it turned out that was quite far from the truth. I learned from example that -- emotions aside -- all it takes to determine the truth is a simple call for evidence.
An article of interest was published in U.S. Pharmacist that may be of interest here.
Here ya go:
Vol. No: 30:06 Posted: 6/15/2005
The USP Dietary Supplement Verification Program: Helping Pharmacists and Consumers Select Dietary Supplements
John Atwater, PhD
Jennifer Montgomery-Salguero, BS
David B. Roll, PhD
United States Pharmacopeia
Rockville, Maryland
US Pharm.2005;6:61-64.
In the fall of 1994, the U.S. Congress passed the Dietary Supplement Health and Education Act (DSHEA). This law treats dietary supplements as foods and defines them as "vitamins, minerals, amino acids, botanicals, and 'other' dietary ingredients." The law contains a number of unusual provisions, not the least of which is that the Food and Drug Administration was given the burden of proving a supplement is harmful rather than requiring that the manufacturer prove that it is safe.
At the time of passage of DSHEA, the FDA estimated that there were about 4,000 dietary supplement products on the market. Since this controversial law was passed, the number of products has increased to more than 29,000, with more than 1,000 products being added each year. The plethora of products makes it extremely difficult for pharmacists, other health care professionals, and consumers to make informed decisions about which brands and products to select. The selection process becomes even more confusing due to widespread reports of adulterated, subpotent or superpotent, and even dangerous dietary supplements. It is apparent that those using and recommending dietary supplements need guidance in the selection process.
In October 2001, the United States Pharmacopeial Convention, Inc. (USP) launched a verification program for dietary supplements designed to provide assurance to consumers that the products they purchase contain the ingredients listed on the label at the stated level(s). In addition, the program evaluates and verifies supplements according to stringent standards for product purity, accuracy of ingredient labeling, and proper manufacturing practices.
Why USP?
USP, founded in 1820, is a nongovernmental, nonprofit organization whose mission is to promote public health. Scientific experts from pharmacy and numerous other fields, including the dietary supplement industry, volunteer their efforts to support USP's work.
Federal law recognizes USP as the official body that sets standards for prescription drugs and dietary supplements. USP has set FDA-recognized standards for more than 4,000 prescription and over-the-counter drugs that pharmaceutical manufacturers are required by federal regulation to meet or exceed. USP has brought that experience to the dietary supplement industry and has developed standards for hundreds of dietary supplement ingredients and products. These standards are compiled in a separate dietary supplements section in the United States Pharmacopeia (USP28). Although supplement manufacturers are not required to comply with USP monographs, according to DSHEA, a dietary supplement represented as meeting USPNF standards is deemed misbranded if it fails to conform to those standards.
Thus, verification of dietary supplements is a natural progression of USP's long-established history of standards setting and promotion of public health.
A Compelling Need
It is estimated that in 2002, Americans spent nearly $19 billion on dietary supplements; nearly half of this was spent on vitamins and minerals, and about one fourth on herbal products. There are numerous reports in the literature of supplements that were found to be inferior in one or more aspects. Clearly, not all supplements are created equal, as is illustrated in FIGURE 1. The calcium supplements taken by this individual over a three-day period are obvious in the x-ray image. It is readily apparent that the tablets have not dissolved and thus are not having their intended effect.
ConsumerLab.com has analyzed 27 multivitamin/mineral supplements for labeled content, disintegration, and lead content. In this study they found that nine of the products failed one or more of the USP requirements. The most common problems related to vitamin A. For example, one children's product contained more than 150% of the labeled content, exceeding the established upper limit for an adult. One of the multiproducts failed the USP disintegration test. Another, a prenatal product, contained only 75% of the amount of folic acid claimed on the label, while one of the multiproducts had only 50% of the claimed amount of this important vitamin. Given what we know about the importance of folic acid in prevention of spina bifida and other neural tube defects, these inferior products should concern all health care professionals.
In a separate study of 32 coenzyme Q10 (CoQ10) supplements tested by ConsumerLab.com, the content ranged from no detectable quantity in one product to 175% of the claimed amount in another. Thus, simply by changing brands, a consumer could go from 0% to 175% of the labeled amount of CoQ10.
Similarly, it is easy to find reports of botanical products that do not meet label specifications. In a recent study published in the Canadian Journal of Clinical Pharmacology, 54 commercial St. John's wort products were tested for the marker compound hypericin. Only two products tested within 10% of the stated label amount, and on average, most products contained only half of the labeled amount of hypericin.
In addition to concerns about the quality of botanical products, a daunting task facing pharmacists and consumers is choosing a product from among the vast number of brands in the marketplace. A recent paper describes a survey of 20 retail stores in a large metropolitan area for products containing the herbs Echinacea, St. John's wort, Ginkgo biloba, garlic, saw palmetto, ginseng, goldenseal, aloe, "Siberian ginseng" (eleuthero), and valerian. For these 10 herbs, consumers had a choice of 880 products and could select from 241 different brands. For example, there were 143 garlic products (33 brands), 138 Ginkgo biloba products (34 brands), and 130 St. John's wort products (34 brands). This survey did not analyze the products for labeled amount but did find that a substantial number of products were not labeled properly and showed a wide variation in label information in regard to plant part ingredients and recommended serving size. In some cases, experienced pharmacists on the survey team were not able to discern ingredient information from the labels. The authors posed the rhetorical question, "If pharmacists trained to interpret pharmaceutical product descriptions are unable to understand the labels for some of these products, how can a layperson make sense of them, much less compare products with a benchmark or with one another or convey this information to their physician?"
The USP verification program for dietary supplements is an attempt to help pharmacists and consumers answer this and other questions regarding dietary supplement quality.
How the Verification Program Works
USP will not accept a product into its verification program if the product contains an ingredient with known safety concerns. However, USP does not comprehensively address the issue of safety. No single program or organization could be expected to completely address this issue because it has broad implications, including drugnutrient interactions, contraindications, and side effects. To thoroughly tackle these issues would require the combined resources of government, industry, and educational institutions. Despite these obstacles, USP has developed a process by which its Dietary Supplement Information Expert Committee evaluates the safety of ingredients so as to prevent those with known safety concerns from entering the verification program. Examples of dietary supplements that have been excluded from the verification program include ephedra, kava, comfrey, chaparral, and the Chinese herb aristolochia.
In the complex, technical world of dietary supplement manufacturing, finished product testing is not enough to ensure the overall quality of dietary supplements. The verification program's principal distinguishing element is the premise that good manufacturing practices (GMPs) are the most essential elements needed to produce a quality product. The program verifies that GMPs are being used by thoroughly examining the manufacturer's quality systems, conducting an on-site audit of compliance with USP's General Chapter <2750> Manufacturing Practices for Dietary Supplements, reviewing quality control and manufacturing product documentation, and performing extensive laboratory testing of products prior to verification.
Once the dietary supplement is granted use of the USP verification mark, USP periodically conducts random off-the-shelf tests on verified products to ensure that they continue to meet the strict program standards, and the organization performs periodic manufacturing site audits to ensure continued compliance with <GMPs>.
Impact of the Verification Program
The verification program has had a significant impact on the quality systems and manufacturing practices of participating companies. Examples include:
• Additional testing for undesirable contaminants.
• Reformulation of products that fail to dissolve.
• Reformulation to ensure the formulation provides 100% of label claim throughout the shelf life of the product.
• Characterization and quantification of botanical marker compounds.
• Implementation of stability study protocols to establish appropriate expiration dating.
• Labeling changes to ensure an accurate list and appropriate quantitative claims for ingredients.
Significance of the USP Verification Mark
The USP verification mark can be used only by manufacturers that are participating in the program, whose manufacturing and quality control facilities have been audited and checked, whose manufacturing documentation has been reviewed, and whose products have been tested by USP for conformance to USPNF standards.
If a product submitted to USP for verification meets the standards of the program, it will be awarded the USP verification mark. FIGURE 2 shows the trademark symbol used to indicate that a product has been verified by USP. The USP mark helps assure consumers, health care professionals, and supplement retailers that the product:
• Has labeling that is accurate.
• Contains the ingredients stated on the label, in the designated amount or strength.
• Meets stringent standards for product purity and passes federal requirements for limits on contaminants, such as heavy metals, pesticides, and microbes.
• Has been manufactured properly and complies with USP and proposed FDA standards for good manufacturing practices, by using safe, sanitary, well-controlled procedures.
Products bearing the USP Verified mark have been available since the beginning of 2003 and can be found in most major drug, food, and discount retailer stores and selected health food stores. It is estimated that by the end of 2004, 20% to 25% of the mass-marketed vitamin and mineral supplements displayed the USP Verified mark.
More information about the program, including participating companies and verified products, can be found at www.uspverified.org.
USP also has a continuing education program which can be presented to pharmacy state associations and other organizations whose members would benefit from learning more about the USP verification process as well as how USP standards can be used to select dietary supplements. More information about this program can be found at the Web site above.
References to cited research can be obtained by contacting the authors at jxs@usp.org.
To comment on this article, contact editor@uspharmacist.com.
Vol. No: 30:06 Posted: 6/15/2005
December 2006
Consumer Reports (expert, independent, non profit) also published a story that may be of interest here as well:
Here is the Consumer Reports article from 2004:
May 2004
Dangerous supplements: Still at large
If you can buy it at a clean, well-lighted store, if it's “all natural,” it's not going to do you serious harm, right? That's what many Americans assume about dietary supplements. But while most supplements are probably fairly benign, Consumer Reports has identified a dozen that according to government warnings, adverse-event reports, and top experts are too dangerous to be on the market. Yet they are. We easily purchased all 12 in February 2004 in a few days of shopping online and in retail stores.
These unsafe supplements include Aristolochia, an herb conclusively linked to kidney failure and cancer in China, Europe, Japan, and the U.S.; yohimbe, a sexual stimulant linked to heart and respiratory problems; bitter orange, whose ingredients have effects similar to those of the banned weight-loss stimulant ephedra; and chaparral, comfrey, germander, and kava, all known or likely causes of liver failure. (For a complete list of the “dirty dozen,” see
12 supplements to avoid.)
CR Quick Take:
A CR investigation found that many dangerous supplements can easily be purchased in stores and online. Many of these supplements have been banned in other countries. Why can't the U.S. Food and Drug Administration ban these products now?
We found that regulatory barriers created by Congress, supplement-industry pressure, and a lack of resources at the FDA have resulted in major risks for consumers.
• These widely available dietary supplements (see 12 supplements to avoid) may cause cancer, severe kidney or liver damage, heart problems, or even death. They should be avoided by consumers.
• These supplements are sold under a profusion of names, making it difficult for consumers to know what they're purchasing.
• Most also appear in combination products marketed for a broad array of uses, such as aphrodisiacs, athletic-performance boosters, and treatments for anxiety, arthritis, menstrual problems, ulcers, and weight loss.
U.S. consumers shelled out some $76 million in 2002 for just three of these supplements: androstenedione, kava, and yohimbe, the only ones for which sales figures were available, according to the Nutrition Business Journal, which tracks the supplement industry.
The potentially dangerous effects of most of these products have been known for more than a decade, and at least five of them are banned in Asia, Europe, or Canada. Yet until very recently, the U.S. Food and Drug Administration had not managed to remove a single dietary supplement from the market for safety reasons.
After seven years of trying, the agency announced a ban on the weight-loss aid ephedra in December 2003. And in March 2004 it warned 23 companies to stop marketing the body-building supplement androstenedione (andro).
Despite these actions against high-profile supplements, whose dangers were so well known that even industry trade groups had stopped defending them, the agency continues to be hamstrung by the 1994 Dietary Supplement Health and Education Act (DSHEA, pronounced de-shay). While drug manufacturers are required to prove that their products are safe before being marketed, DSHEA makes the FDA prove that supplements on the market are unsafe and denies the agency all but the sketchiest information about the safety record of most of them.
“The standards for demonstrating a supplement is hazardous are so high that it can take the FDA years to build a case,” said Bruce Silverglade, legal director of the Center for Science in the Public Interest, a Washington, D.C., consumer-advocacy group.
At the same time, the FDA’s supplement division is understaffed and underfunded, with about 60 people and a budget of only $10 million to police a $19.4 billion-a-year industry. To regulate drugs, annual sales of which are 12 times the amount of supplement sales, the FDA has almost 43 times as much money and almost 48 times as many people.
“The law has never been fully funded,” said William Hubbard, FDA associate commissioner for policy and planning. “There's never been the resources to do all the things the law would command us to do.”
The agency has learned that it must tread carefully when regulating supplements. The first time it tried to regulate the dangerous stimulant ephedra, in 1997, overwhelming opposition from Congress and industry forced it to back down.
As a result, the FDA is sometimes left practicing what Silverglade calls “regulation by press release”--issuing warnings about dangerous supplements and hoping that consumers and health practitioners
read them.
There are signs of hope. The FDA has said that if the ban on ephedra holds up against likely legal challenges, it plans to go after other harmful supplements. Legislation has been introduced to strengthen the FDA's authority under DSHEA and give the agency more money to enforce the act.
But the supplement marketplace still holds hidden hazards for consumers, especially among products that aren't in the headlines. “Consumers are provided with more information about the composition and nutritional value of a loaf of bread than about the ingredients and potential hazards of botanical medicines,” said Arthur Grollman, M.D., professor of pharmacological sciences at the State University of New York, Stony Brook, and a critic of DSHEA.
A question of safety
Supplement-industry advocates say the ephedra ban demonstrates that DSHEA gives the FDA enough power to protect consumers from unsafe products. “I don't think there's anything wrong except that FDA has only recently begun vigorous and active enforcement of the law,” said Annette Dickinson, Ph.D., president of the Council for Responsible Nutrition, a major trade association for the supplement industry.
But critics of DSHEA think the ban illustrates the extremes to which the FDA must go to outlaw a hazardous product.
When the agency initially tried to rein in ephedra use in 1997, after receiving hundreds of reports of adverse events, it sought not an outright ban but dosage restrictions and sterner warning labels. The industry mounted a furious counter-attack, including the creation of a public-relations group called the Ephedra Education Council and a scientific review from a private consulting firm, commissioned by Dickinson's trade group, that concluded ephedra was safe. After the U.S. General Accounting Office said the FDA “did not establish a causal link” between taking ephedra and deaths or injuries, the agency was forced to drop its proposal.
SUFFERED seizure
Gretchen Fitzgerald, age 21, Fort Collins, Colo.
PROBLEM She took Xenadrine EFX “thermogenic” diet pills to boost her energy while studying for final exams, believing they were safe because they were labeled ephedra-free. After three weeks of taking the product she had a seizure. The neurologist consulted told her the bitter orange in the Xenadrine was the probable cause. Xenadrine’s manufacturer did not return our phone calls. Since going off the Xenadrine, Fitzgerald has had no further problems.
The industry continued to vigorously market and defend ephedra. Metabolife International, a leading ephedra manufacturer, did not let the FDA know that it had received 14,684 complaints of adverse events associated with its ephedra product, Metabolife 356, in the previous five years, including 18 heart attacks, 26 strokes, 43 seizures, and 5 deaths. It took the pressure of congressional and Justice Department investigations to get the company to turn over the complaints in 2002. Then Steve Bechler, a pitcher for the Baltimore Orioles, died unexpectedly in 2003 while taking another ephedra supplement, Xenadrine RFA-1. With sales suffering from the bad publicity, manufacturers began to replace ephedra with other stimulants such as bitter orange, which mimics ephedra in chemical composition and function.
“All of a sudden Congress dropped objections to an ephedra ban andstarted demanding the FDA act,” said Silverglade.
To amass the necessary scientific evidence that it hoped would satisfy the demanding standard set by DSHEA, the FDA took aggressive action: It commissioned an outside review from the RAND Corporation, analyzed adverse-event reports, and pored over every available shred of scientific evidence.
“We’ve gone the whole nine yards to collect and evaluate all the possible evidence,” Mark McClellan, commissioner of the FDA, said in announcing the ban. “We will be doing our best to defend this in court, and if that’s not sufficient, it may be time to re-examine the act.”
Drugs vs. supplements
In an October 2002 nationwide Harris Poll of 1,010 adults, 59 percent of respondents said they believed that supplements must be approved by a government agency before they can be sold to the public. Sixty-eight percent said the government requires warning labels on supplements’ potential side effects or dangers. Fifty-five percent said supplement manufacturers can’t make safety claims without solid scientific support.
They were wrong. None of those protections exist for supplements--only for prescription and over-the-counter medicines. Here are the major differences in the safety regulations:
Testing for hazards. Before approval, drugs must be proved effective, with an acceptable safety profile, by means of lab research and rigorous human clinical trials involving a minimum of several thousand people, many millions of dollars, and several years.
In contrast, supplement manufacturers can introduce new products without any testing for safety and efficacy. The maker’s only obligation is to send the FDA a copy of the language on the label (see
Supplement labels).
“Products regulated by DSHEA were presumed to be safe because of their long history of use, often in other countries,” said Jane E. Henney, M.D., commissioner of the FDA from 1998 to 2001. “As their use dramatically increased in this country after the passage of DSHEA, the presumption of safety may have been misplaced, particularly for products other than traditional vitamins and minerals. Some, like ephedra, act like drugs and thus have similar risks.”
The only exceptions to this “presumption of safety” are supplement ingredients that weren’t being sold in the U.S. when DSHEA took effect. Makers of such “new dietary ingredients” must show the FDA evidence of the products’ safety before marketing them. The FDA invoked that rarely used provision in its action against androstenedione. After years of allowing andro to be marketed without restriction, the agency declared that it was “not aware” that the supplement was used before DSHEA, so it couldn’t be sold without evidence of safety.
Disclosing the risks. Drug labels and package inserts must mention all possible adverse effects and interactions. But supplement makers don’t have to put safety warnings on the labels, even for products with known serious hazards.
We bought a product called Relaxit whose label had no warning about the kava it contained, even though the American Herbal Products Association, an industry trade group, recommends a detailed, though voluntary warning label about potential liver toxicity on all kava products.
Ensuring product quality. Drugs must conform to “good manufacturing practices” that guarantee that their contents are pure and in the quantities stated on the label. While DSHEA gave the FDA authority to impose similar standards on supplements, it took until 2003 for the agency to propose regulations--as yet not final--to implement that part of the law.
Contaminants, too, regularly turn up in supplements. In 1998 Richard Ko, Ph.D., of the California Department of Health Services reported that 32 percent of the Asian patent medicines he tested contained pharmaceuticals or heavy metals that weren’t on the label. In 2002, the FDA oversaw a voluntary manufacturer recall of a "prostate health" supplement called PC SPES that, according to tests by the California department, contained a powerful prescription blood thinner, warfarin.
Reporting the problems. By law, drug companies are required to tell the FDA about any reports of product-related adverse events that they receive from any source. Almost every year, drugs are removed from the market based on safety risks that first surfaced in those reports.
In contrast, supplement makers don’t have to report adverse events. Indeed, in the five years after DSHEA took effect, 1994 to 1999, fewer than 10 of the more than 2,500 reports that the FDA received came from manufacturers, according to a 2001 estimate from the inspector general of the U.S. Department of Health and Human Services. (Other sources of reports included consumers, health practitioners, and poison-control centers.) Overall, the FDA estimates that it learns of less than 1 percent of adverse events involving dietary supplements.
THE ‘NATURAL’ MYSTIQUE
Many makers market their supplements as “natural,” exploiting assumptions that such products can’t harm you. That’s a dangerous assumption, said Lois Swirsky Gold, Ph.D., director of the Carcinogenic Potency Project at the University of California, Berkeley, and an expert on chemical carcinogens. “Natural is hemlock, natural is arsenic, natural is poisonous mushrooms,” she said.
A cautionary example is aristolochic acid, which occurs naturally in species of Aristolochia vines that grow wild in many parts of the world. In addition to being a powerful kidney toxin, it is on the World Health Organization’s list of human carcinogens. “It’s one of the most potent chemicals of 1,400 in my Carcinogenic Potency Database,” Gold said. “People have taken high doses similar to the doses that animals are given in tests, and they both get tumors very quickly.”
KIDNEYS FAILED
Beverly Hames, age 59, Beaverton, Ore.
PROBLEM Hames went to an acupuncturist in 1992 seeking a “safe, natural” treatment for an aching back. She got a selection of Chinese herbal products, at least five of which were later found to contain aristolochic acid. By mid-1994, she had symptoms of kidney failure, and in 1996 she underwent a kidney transplant. She must take anti-rejection drugs (below) for life. The herbs’ distributor said his Chinese suppliers had substituted Aristolochia for another herb without his knowledge.
The dangers of aristolochic acid have been known since at least 1993, when medical-journal articles began appearing about 105 patrons of a Belgian weight-loss clinic who had suffered kidney failure after consuming Chinese herbs adulterated with Aristolochia. At least 18 of the women also subsequently developed cancer near
the kidney.
These findings prompted the FDA to issue a nationwide warning against Aristolochia in 2001 and to impose a ban on further imports of the herb. But in early 2004, more than two years after the import ban went into effect, Consumer Reports was able to purchase products online that were labeled as containing Aristolochia.
In 2003, Gold identified more than 100 products for sale online with botanical ingredients listed by the FDA as known or suspected to contain aristolochic acid.
Donna Andrade-Wheaton, a former aerobics instructor in Rhode Island, learned those facts too late to save her kidneys. After taking Chinese herbs containing Aristolochia for more than two years, she suffered severe kidney damage; her kidney tissues were found to contain aristolochic acid. In late 2002, at age 39, she underwent a kidney transplant.
Andrade-Wheaton is suing both the acupuncturist who gave her the herbs and several companies that manufactured them. The acupuncturist declined to discuss the case on the record, and the manufacturer did not return our phone calls.
There’s another widespread and false assumption about natural supplements: that they’re always pure, unprocessed products of the earth. Because DSHEA permits the marketing of concentrates and extracts, supplement makers can and do manipulate ingredients to increase the concentrations of pharmacologically active compounds.
That’s especially true of the many weight-loss supplements designed for “thermogenic” stimulant effects--boosting calorie expenditure by revving the metabolic rate.
On one Internet shopping tour, for instance, we bought a product called Thermorexin--”the Hottest new Thermogenic on the market!” Its label says it contains, among its 22 ingredients, 30 milligrams of theophylline derived from a black tea extract and the stimulant bitter orange. Sold as Theo-Dur and other brands, theophylline is a prescription drug and an effective asthma treatment, but most doctors seldom prescribe it because it can cause seizures and irregular heartbeats at relatively low doses.
Larry Berube, president of Anafit, Thermorexin’s manufacturer, based in Orlando, Fla., described how the product’s combination of ingredients was developed: “Once we find out that the FDA says it’s OK, we put them together in the lab, run our tests, and do our trials, and if it comes up good, we capsulate it, put it online and in the stores and sell it,” he said.
Those tests involved asking fitness professionals to use the supplement, and measuring their heart rate and blood pressure, Berube said. The company doesn’t use a control group, he said. Then “we go to the fitness discussion boards and let trainers and people know we have a new product and do they want to try it,” he said. “And then they try it, and they report back.” Berube said he has not heard of any bad reactions to Thermorexin.
KIDNEYS FAILED
Donna Andrade-Wheaton, age 40, Cranston, R.I.
PROBLEM Andrade-Wheaton’s acupuncturist prescribed more than a half dozen Chinese herbal supplements to treat health conditions, including endometriosis. At least one of the products listed Aristolochia as an ingredient, even after the FDA issued a nationwide Aristolochia safety warning in 2001. She underwent a kidney transplant in September 2002 and must take anti-rejection drugs (below) for life.
Copyright © 2000-2006 Consumers Union of U.S., Inc. No reproduction, in whole or in part, without written permission.
So I guess the prerequisites for safely taking supplements are:
1) Start by asking your Doctor for advice
2) Choosing supplements with the USP mark
-- All else is gambling with your health.
Take care, and be safe.
