The best possible outcome I could see here in this supplement debacle is that all companies start performing and providing the results of very rigorous testing.
The products that are of primary concern for us taking supplements in the UNITED STATES are mostly limited to those labeled as "dietary supplement" products. You do realize that a "dietary supplement" sold in the United States is regulated like a food product...and there are PLENTY of restaurants I would NEVER eat at simply due to the ingredients they use...then, of course, I need take into consideration the workplace in which the meals are manufactured; and whether or not the employees are disgruntled or not...so if my food drops onto the floor, what would the employee/management do? If they throw it away, then they will have to make me another veggie burger at a profit loss from the burger, and the employees time; or they can just scrape off the dead cockroach, place it on the same bun, then serve it to me...who would notice, right? But hey, that's a profit loss! I bet in many cases, employees and management simply look the other way as they don't want their pocketbook to suffer. If Piracetam is regulated in a similar fashion, why wouldn't Piracetam be vounerable to such contamination? Especially since these products come from countries with much weaker economies than the United States; where a chemist's time cost 1/8 an American's wage; and the ingredients used might not be the same as a drug for human use. Ever notice why many nootropics don't have a company of manufacture on the COA? Well, that's because they are often manufactured in CHEMICAL FACTORIES where plastics, varnishes, etc. are made. There are a speciific set of chemicals used to manufacture a drug for HUMAN use...and another set used to manufacture CHEMICALS (such as insect replellent and Windex) you probably don't want your supplements made by the same lab that makes your Windex or Lysol! To learn more about these standards visit the ICH site:
http://www.ich.org/c.../276-254-1.htmlFrom this page:
http://www.naturalpr...and of and GMPsMaking Sense of GMPs
09/01/2000
The History of GMPs for Dietary Supplements
The Dietary Supplement Health and Education Act of 1994 (DSHEA) authorized but did not require the FDA to adopt new federal regulations for GMPs for dietary supplements. Under DSHEA, the FDA can issue GMP regulations for dietary supplements that are modeled after food GMPs. A number of organizations developed a model for the regulations and passed it to FDA in late 1995. The sponsors were the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association (NNFA) and the Utah Natural Products Alliance (UNPA).
"In DSHEA, Congress ordered FDA to model any specific GMPs for supplements on food GMPs," Ullman said. "The food GMPs [as opposed to pharmaceutical GMPs] had less rigorous steps to take against impurity--not every batch needs to be tested and record retention isn't as rigorous."
It's pretty freaky the amount of contaminated dietary supplements going around the market. Even in spices!
Childhood Lead Poisoning in 2 Families Associated With Spices Used in Food Preparation
Alan D. Woolf, MD, MPH*,, and Nicholas T. Woolf||
* Pediatric Environmental Health Subspecialty Unit, Boston, Massachusetts
Division of General Pediatrics, Children's Hospital, Boston, Massachusetts
Department of Pediatrics, Harvard Medical School, Boston, Massachusetts
|| Lexington Christian Academy, Lexington, Massachusetts
Although most cases of childhood lead poisoning are caused by contaminated paint and dust in older homes, a variety of unusual sources of lead exposure are occasionally found. We report here 2 families whose children were poisoned by lead-contaminated spices that were purchased in foreign countries, brought to the United States, and then used in the preparation of the family�s food. Six children (2�17 years old) in a family from the Republic of Georgia were poisoned by swanuri marili (lead content: 100 and 2040 mg/kg in separately sampled products) and kharchos suneli (zafron) lead content: 23 100 mg/kg) purchased from a street vendor in Tbilisi, Georgia. The second family had purchased a mixture of spices called kozhambu (lead content: 310 mg/kg) while traveling in India. Both the parents and their 2-year-old child subsequently suffered lead poisoning. The young children in both families required short-term chelation to bring their blood lead levels down to a safer range. Clinicians should be vigilant for all sources of lead contamination, including spices, when whole families are found to have elevated blood lead levels despite a confirmed lead-safe home environment. Families traveling abroad should be aware of the potential health risks associated with the purchase and use of spices that have not been tested for purity.
"Herbal poisoning exposures reported to poison centers increased by 344% after passage of the Dietary Supplement Health and Education Act, with 24412 exposures reported in 2003."
(1).Journal of Pharmacy Practice, Vol. 18, No. 3, 188-208 (2005)
DOI: 10.1177/0897190005277217
� 2005 SAGE Publications
Herbal Product Contamination and Toxicity
Susan C. Smolinske, PharmD, DABAT
Children�s Hospital of Michigan Regional Poison Control Center, Wayne State University, College of Medicine, Department of Pediatrics, Detroit, Michigan
Herbal poisoning exposures reported to poison centers increased by 344% after passage of the Dietary Supplement Health and Education Act, with 24412 exposures reported in 2003. Increased toxicity is speculated to be related to lack of child-resistant packaging, new issues of contamination, proliferation of multiple ingredient products, excessive concentration of active ingredients, and discovery of new drug-herb interactions. This review addresses contamination issues such as heavy metals, pharmaceuticals, homeopathic remedies, microbes, insects, environmental chemicals, and mis-identification of one plant for another. Toxicity issues covered include carcinogenicity, delay in seeking medical treatment when using herbs to treat serious illness, toxic components, hypersensitivity reactions, hepatotoxins, nephrotoxins, epileptogenic compounds, cardiac toxins, gastrointestinal toxins, and hematologic toxins. Common drug-herb interactions are discussed. The pharmacist plays an important role in patient education and evaluation of potential toxicities related to herbal supplements.
Lead is a commonly found contaminant that can drasically lower human IQ; even at low enough doses where it is considered "safe" (at or equal 10 �g per deciliter in blood).
http://content.nejm....act/348/16/1517Volume 348:1517-1526 April 17, 2003 Number 16
Intellectual Impairment in Children with Blood Lead Concentrations below 10 �g per Deciliter
Richard L. Canfield, Ph.D., Charles R. Henderson, Jr., M.A., Deborah A. Cory-Slechta, Ph.D., Christopher Cox, Ph.D., Todd A. Jusko, B.S., and Bruce P. Lanphear, M.D., M.P.H.
Background Despite dramatic declines in children's blood lead concentrations and a lowering of the Centers for Disease Control and Prevention's level of concern to 10 �g per deciliter (0.483 �mol per liter), little is known about children's neurobehavioral functioning at lead concentrations below this level.
Methods We measured blood lead concentrations in 172 children at 6, 12, 18, 24, 36, 48, and 60 months of age and administered the Stanford�Binet Intelligence Scale at the ages of 3 and 5 years. The relation between IQ and blood lead concentration was estimated with the use of linear and nonlinear mixed models, with adjustment for maternal IQ, quality of the home environment, and other potential confounders.
Results The blood lead concentration was inversely and significantly associated with IQ. In the linear model, each increase of 10 �g per deciliter in the lifetime average blood lead concentration was associated with a 4.6-point decrease in IQ (P=0.004), whereas for the subsample of 101 children whose maximal lead concentrations remained below 10 �g per deciliter, the change in IQ associated with a given change in lead concentration was greater. When estimated in a nonlinear model with the full sample, IQ declined by 7.4 points as lifetime average blood lead concentrations increased from 1 to 10 �g per deciliter.
Conclusions Blood lead concentrations, even those below 10 �g per deciliter, are inversely associated with children's IQ scores at three and five years of age, and associated declines in IQ are greater at these concentrations than at higher concentrations. These findings suggest that more U.S. children may be adversely affected by environmental lead than previously estimated.
Source Information
From the Division of Nutritional Sciences (R.L.C.) and the Department of Human Development (C.R.H.), College of Human Ecology, Cornell University, Ithaca, N.Y.; the Departments of Environmental Medicine (D.A.C.-S.) and Biostatistics and Computational Biology (C.C.), University of Rochester School of Medicine, Rochester, N.Y.; the Division of Epidemiology, Statistics, and Prevention, National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, Bethesda, Md. (C.C.); the Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle (T.A.J.); and Cincinnati Children's Environmental Health Center, Children's Hospital Medical Center, Cincinnati (B.P.L.).
Address reprint requests to Dr. Canfield at the Division of Nutritional Sciences, College of Human Ecology, Cornell University, Ithaca, NY 14853, or at rlc5@cornell.edu.
Contamination has been found in many "dietary supplement" products that are available at your local health food store. From consumerlab.com:
http://www.consumerl...lts/ginseng.aspSpecific types of ginseng may be helpful in diabetes control, the prevention of respiratory infections, sexual enhancement and other uses. But ConsumerLab.com has found problems in many ginseng supplements over the years. In this newest Review, six products failed to pass testing due to lead contamination, lack of ingredient, or inadequate labeling. One product had less than 10% of its claimed amount of ginsenosides despite its "EXTRA STRENGTH" label. A major store brand product was contaminated with lead.
Seven products passed the testing, along with four products tested through ConsumerLab.com's certification program. And two products similar to products that passed are identified. Testing focused on Asian ginseng (Panax ginseng) (also called Korean or Chinese ginseng) and American ginseng (Panax quinquefolius).
Included in the report are Ginsana (Alan James Group, LLC), Imperial Elixir (GINCO International), Kinetana (Biogenesis Nutraceuticals, Inc), Royal King (Herba Natural Products Inc.), Hsu's Root to Health (Ginseng Enterprises, Inc.), Hi-Ener-G (Windmill� Health Products) as well as products from by CVS Pharmacy, Paradise Herbs, Pharmanex, Puritan's Pride, Spring Valley, Vitamin World, Walgreens, Sundown, Swanson, ActionLabs, and TruNature.
Green tea and Selenium, and Lycopene supplements sold in the US also can't match their label claim or are otherwise contaminated as well:
http://www.consumerl...ne_selenium.aspCertain foods and nutrients are associated with a reduced risk of cancer. Many of these are anti-oxidants, scavenging free radicals that can otherwise damage cells. Supplements containing three popular ingredients � green tea, lycopene or selenium � were purchased and tested. [See separate reports on this site for other ingredients used for cancer prevention: folate, garlic, isoflavones, vitamin C, vitamin D, and vitamin E.]
But problems were detected in three green tea products: Two were contaminated with lead and another contained only 71% of its claimed level of EGCG, a key compound in green tea. One selenium supplement contained only 38% of its ingredient.
Brands covered in the review include those from Bluebonnet, Canadian Sun, Country Life, GNC, Food Science of Vermont, Futurebiotics, Herbal Select, Jarrow, KAL, Life Extension, Metabolic Maintenance, Nature's Answer, Nature's Bounty, Pharmanex, Puritan's Pride, Schiff, Vitamin World, and Whole Foods.
Other scientific research conducted on dietary supplement products sold in the USA:
A study of ginseng products found tremendous variability, with as little as 12% and as much as 328% of the active ingredient in the bottle, compared to the information on the label
(Am J Clin Nutr. 2001. 73. 1101-1106). A study of 59 Echinacea products from retail stores analyzed by thin layer chromotography showed that 6 contained no measurable Echinacea and only 9 of the 21 preparations labelled as standardized extracts actually contained in the sample the content listed on the label. Overall, the assay results were consistent with the labelled content in only 31 of the59 preparations
(Arch Intern Med. 2003. 163. 699-704). When the FDA announced in 2003 a proposed rule to establish good manufacturing practices for supplements, the FDA cited data that 5 of 18 soy and/or red clover supplements contained only 50-80% of the quantity of isoflavones stated on the label, and 8 of 25 probiotic products contained less than 1% of the live bacteria claimed on the label.
Additional quality issues include contamination of some herbs with other botanicals, micro-organisms, microbial toxins, fumigating agents, pesticides, heavy metals, or prescription or over the counter drugs.
In 1998 the California Department of Health reported in a letter published in the New England Journal of Medicine that 32% of Asian patent medicines sold in that state contained undeclared pharmaceuticals or heavy metals, including ephedrine ( a stimulant), chlorpheniramine (an antihistamine), methyltestosterone (an anabolic steroid), phenacetin (a pain killer), lead, mercury, and arsenic
(N Engl J Med. 1998. 339. 847). A study in which 500 Asian patent medicines were screened for the presence of heavy metals and 134 drugs found that 10% were contaminated
(Bull Environ Contam Toxicol. 2000. 65. 112-119). A study in which all unique Ayurvedic herbal medicine products were purchased from all stores within 20 miles of Boston City Hall found that 14 of 70 products (20%) contained heavy metals and that if taken as recommended by the manufacturer, each of these 14 products could result in heavy metal intakes above published regulatory standards
(JAMA. 2004. 292. 2868-2873). Adulteration of imported Chinese dietary supplements sold in Japan is responsible for 622 cases of illness, 148 hospitalizations, and 3 deaths
(Report of the Japanese Ministry of Health, Labor, and Welfare. September 20, 2002).A 2002 Bastyr University study of 20 probiotic supplements found that 16 contained bacteria not listed on the label, 6 contained organisms that can make people sick, and 4 contained no live organisms.
PC-SPES was removed from the market in 2002 after it was determined that it was adulterated with the prescription blood thinner, warfarin.
Edited by nootropikamil, 29 April 2007 - 09:27 PM.
