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NEWS: Deborah Josefson Popping a multivitamin daily can keep disease at bay BMJ 2002; 324: 1544a [Full text]

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How to get vitamins in an unregulated industry

Michael T. Grubic, Shirley Burris, Betty Nixdorf   (29 June 2002)

Re: How to get vitamins in an unregulated industry

Anssi H. Manninen, Luke R. Bucci, Weider Nutrition International, Inc., USA.   (2 July 2002)

Re: How to get vitamins in an unregulated industry II

Anssi H. Manninen   (5 July 2002)

Re: Re: How to get vitamins in an unregulated industry II

Michael T Grubic   (12 July 2002)

How to get vitamins in an unregulated industry 29 June 2002
Michael T. Grubic, Nutritional Consultant 320 S. Market Ave, Mount Joy, PA 17552, Shirley Burris, Betty Nixdorf Send response to journal: Re: How to get vitamins in an unregulated industry	The article on the benifits of taking multi-vitamins to prevent disease has a fatal flaw. Since the vitamin/supplement industry is for the most part unregulated, it is extremely difficult for the public to know if the vitamins in the label of a particular brand of supplements actually includes these in the pills nor does it insure that the amounts represent what is in each pill. Numerous organizations have tested and proven that large percentages of store-bought brands of supplements are lacking in dependability. In addition, there are no regulations to require that manufactures prove that the nutritional elements in the pills are actually bio- available. The simply pass through or take too long to break down into small enough particles to be of any use. Then you also have the natural versus synthetic argument. There are very few supplement manufacturers that produce their products using near-prescription medicine manufacturing and testing procedures. These are some of the main reasons the medical practioner hs a difficult time recommending supplements. Most are undependable. While I have found such companies, it took a lot of research that the public will not perform. They will continue or begin to take vitmins thinking they are being protected only to find out when it is too late that they were decieved. This will classify me as having a "competing interest" in that the results of my research caused me to become an Independent Distributor of one of these companies.
Re: How to get vitamins in an unregulated industry 2 July 2002
Anssi H. Manninen Department of Physiology, Medical School, University of Oulu, Finland, Luke R. Bucci, Weider Nutrition International, Inc., USA. Send response to journal: Re: Re: How to get vitamins in an unregulated industry	Dietary supplements are most definitely regulated, and any reports that the industry is unregulated are untrue. The Federal Food Drug & Cosmetic Act prohibits misbranding and adulterations of food, drugs, and dietary supplements. DSHEA provides procedures for making claims about dietary supplements and how they affect the structure and function of the body. Further, the FDA reviews all statements made in labeling. Usually, with only a few exceptions, the vitamins in pills are utilized and handled by the body just as efficiently, or more so, than the vitamin forms found in foods. One exception is vitamin E. The natural forms, called d-alpha-tocopherols, are absorbed and utilized twice as well as the synthetic forms, denoted by dl-alpha tocopherol. There might also be some differences in utilization between synthetic and natural beta carotene (vitamin A precursor), vitamin Ds and vitamin Ks.
Re: How to get vitamins in an unregulated industry II 5 July 2002
Anssi H. Manninen Send response to journal: Re: Re: How to get vitamins in an unregulated industry II	http://www.crnusa.org: Friday, February 16, 2001 Contact: Annette Dickinson 202/872-1488 Multivitamins Pass Tests With Flying Colors WASHINGTON- February 16, 2001 An independent testing lab recently tested 27 multivitamin products to determine whether products are delivering what the label claims they provide. Almost all the multivitamins passed with flying colors. Only one instance is cited of a product failing to meet the label claim. Also, none of the products had unacceptable levels of lead. Products that passed included national brands such as One A Day, Centrum, Nutrilite, Geritol, Theragran-M, Stuart Prenatal, and Poly-Vi-Sol, plus a number of store-brand multivitamins including those marketed by Kmart, Walgreen, and Safeway. Of course, in this limited sample, many brands were not tested. The tests were performed by ConsumerLab.com. Since the fact that almost all of the multivitamins passed the key test might not be considered "hot news," ConsumerLab attempted to create a more compelling story by focusing on the "upper limits" recently recommended by the Institute of Medicine of the National Academies. ConsumerLab says it is "startling" that some products contain nutrients in excess of the newly established upper limits. "There is nothing startling or unsafe about the levels of nutrients found in these multivitamins," said John Hathcock, Ph.D., Vice President for Nutritional Science and Regulatory Affairs for the Council for Responsible Nutrition (CRN). "The upper limits established by the Institute of Medicine are intakes that are not only safe, but safe by a comfortable margin. They are not regulatory limits." The Food and Drug Administration establishes the reference values for nutrient intake to be used in all nutrition labeling, for conventional foods as well as dietary supplements. Since 1973, the FDA reference amount for vitamin A has been 5000 IU for children 4 years of age or older, and for adults. The reference amount for children 2 or 3 years of age has been 2500 IU. These values have served as the basis for safe and beneficial levels of vitamin A in children’s and adults’ multivitamins as well as fortified breakfast cereals for the past 37 years, with no evidence of any problem. "Products with a proven safety record have not suddenly become unsafe merely because the latest report issued by the Institute of Medicine in January 2001 recommends somewhat lower limits for vitamin A for some age groups. The report will obviously be taken into account when FDA revises the existing regulations," said Annette Dickinson, CRN’s Vice President for Scientific and Regulatory Affairs. (NOTE: The Institute of Medicine’s recommended upper limits for vitamin A for young children are: 2000 IU for children 1-3 and 3000 IU for children 4-8. Upper limits for older children and for men and women range from 5700 IU to 10,000 IU.) All foods containing added vitamins or minerals are required by the Food and Drug Administration (FDA) to contain 100% of the amount claimed on the label, whether the products are dietary supplements or breakfast cereals. In order to accomplish this, it is necessary to add more than 100%, because vitamins are not stable, and they deteriorate over time. FDA regulations permit appropriate excesses to be added at the time of manufacture, to compensate for this. In its evaluation, ConsumerLab wrongly criticizes some products for containing more than 100% of the recommended amounts of some vitamins, implying a safety issue where none exists. "It is unjustified and counterproductive for ConsumerLab to imply that there is any safety issue involved in consuming vitamins at the levels reported in these products," said Dr. Hathcock.
Re: Re: How to get vitamins in an unregulated industry II 12 July 2002
Michael T Grubic, nutritional consultant 17552 Send response to journal: Re: Re: Re: How to get vitamins in an unregulated industry II	It would be wonderful if it were true, but unfortunately the FDA does not have the resources to ensure quality. Here are a few examples: (I have not verified any other than #1) 1) Feifer AH, Fleshner NE, Klotz L. Department of Surgery, Division of Urology, Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada. PURPOSE: We determine the analytical accuracy and reliability of commonly used nutritional supplements for prostate disease by comparing the amounts of active ingredients of several brands of vitamin E, vitamin D, selenium, lycopene and saw palmetto. We also compared the amounts of active compound in different lots of the same brand to determine the consistency of the manufacturing process. MATERIALS AND METHODS: Samples purchased at pharmacies and specialty stores were sent for independent chemical analysis. The measured dose was compared to the stated dose on the product label. Analysis of variance was performed to test for significance in interlot reliability. RESULTS: Vitamin E (7 samples) and selenium (5) were within a range of -41% to +57% and -19% to +23% of the stated dosage, respectively. All vitamin D brands (4 samples) were within 15% of the stated dose. Saw palmetto (6 samples) were within a range -97% to +140% of the stated dosages with 3 containing less than 20% of the stated dosages. Lycopene brands were between -38% and +143% of stated dosages. Among the reliability assays 1 of 3 brands of vitamin E, 1 of 2 brands of selenium and 1 of 2 brands of saw palmetto demonstrated statistical differences in interlot dosage (p <0.0055, approximate 20% to 25% differences in dose). The 1 assayed form of vitamin D was reliable between lots. CONCLUSIONS: Commonly used nutritional supplements for prostate disease vary widely in measured dose. Saw palmetto demonstrated tremendous variability with some samples containing virtually no active ingredients. In contrast, the more regulated substances we measured, such as vitamins and minerals, demonstrated less variation. 2) "Many brands of St. John's Wort may be lacking in an active ingredient. A new study published in the American Journal of Health-System Pharmacy tested eight brands of St. John's Wort, a popular dietary supplement used for depression, and found wide variations in their amounts of hyperforin, and important active ingredient. Only two contained enough of the ingredient to be clinically therapeutic." 3) Regarding BIOAVAILABILITY (which means....do the nutrients in the product get absorbed into the bloodstream AND is there published, clinical evidence to prove it?) A simple test on Vitamin E showed the following results: Five brands of 200 I.U. Vitamin E were tested for delivery to the blood stream. The results were: Brand 1 = 0.15 units absorbed, Brand 2 = 15.0 units absorbed, Brand 3 = 1.0 units absorbed, Brand 4 = 67.0 units absorbed, Brand 5 = 200.0 units absorbed (this was Shaklee) 4) PRODUCT STABILITY is a big issue. Here's an example: Acidophilus and Bifidus products are being highly promoted today. BUT the following is a university study showing the amount of active bacteria found when microflora products were randomly selected and tested off the store shelf: The label claimed the following numbers "At the time of manufacture": Obviously the body will benefit only from what gets delivered to the intestines. Label Claim Microanalysis Results: Brand 1: 2 billion/NONE, Brand 2: 100 million/1,500 only, Brand 3: 250 billion/30 million, Brand 4: 1 million/NONE, Brand 5: 500 million/500 million 5) In January 2000, the University of Guelph did an investigative report and found the following: They tested JAMIESON, Imperial Ginseng, Red Dragon Brand (on the label it said "Premium Ginsengs of the Chinese Emperors") They were 500 mg capsules. Two test lots were done: Lot #1 = 0.3 mg active ginsenosides per 500 mg capsule, Lot #2 = NO active ginsenosides per 500 mg capsule The results are obvious - this product is pretty useless. 6) In 1998 the U.S. Department of Agriculture Report randomly selected 43 Ginseng-labeled products and tested them for active ingredients. The results: 39 of 43 had NONE. THAT IS 91% 7) In January 2000, the University of Guelph reported on Garlic tablets tested: 100% of all Garlic tablets tested DID NOT meet the label claim for "Allicin" -the medicinal ingredient in Garlic. 33% had NO ACTIVE ALLICIN at all. 8) This was a 1999 CLTV report on St. John's Wort. 70% of products tested contained fewer active ingredients than the industry standard. 10% contained NO ACTIVE INGREDIENTS. 9) This was the same 1999 CLTV report on Ginkgo Biloba. 50% of Ginkgo Biloba products tested contained fewer active ingredients than the industry standard. 25% contained NO ACTIVE INGREDIENTS. The following is from Dr. Steve Chaney who established and teaches nutrition in the Univ. North Carolina Medical School. A study at Duke University examined 12 bottles of one popular supplement. These samples showed they contained 60% or less of the amount of nutrients claimed on the label!