Compiled by Walter Sorochan
Posted January 24, 2016.
This article summarizes the status of dietary supplement industry and the federal agencies supposedly regulating it. Attention to this topic was focused by a series of reports by Frontline. Frontline Report video, Jan 19, 2016
The information by Frontline in 2016 was not the first TV media to bring attention to the lack of dietary supplement control and ineptitude by the federal government agencies like the Federal Food and Drug Administration in protecting the public. There have been numerous observations reporting drug research that distorted research findings or distorting the outcome of health and food research using inappropriate research designs that resulted in reporting misinformation. Here are just a few of these reports:
The supplement industry came under attack in 2016 by FRONTLINE [Public Broadcast System ( PBS ) an investigative journalism that questions, explains and changes our world], The New York Times and the Canadian Broadcasting Corporation examine the hidden dangers of vitamins and supplements, a multibillion-dollar industry with limited FDA oversight.
There have been more than 400 recalls of supplements since 2008, mostly for products marketed for bodybuilding, weight loss and sexual enhancement, says Consumer Reports. Jaslow: Hidden dangers of vitamins 2012
“The FDA [Food and Drug Administration] does not do any review of dietary supplements before they come onto the market, and I think that all consumers need to understand this,” Stephen Ostroff, M.D., acting commissioner of the FDA, tells FRONTLINE. The regulations for supplements are very lax: Unlike medicines, supplements are not put through the same tests by government authorities to determine whether or not they are safe. The manufacturers are given the responsibility of making sure that they are safe; they have to make sure that the products are correctly labeled, that they meet minimum quality standards and that they have no impurities or contaminants. Apart from that, there is very little governmental intervention when it comes to supplements.
The FDA. said, on January 12, 2016, that its review of the available information on BMPEA “does not identify a specific safety concern at this time.” A spokeswoman for the agency reiterated that statement on January 14, 2016. But Dr. Pieter A. Cohen, an assistant professor at Harvard Medical School and the lead author of the new study on BMPEA, said that the agency was abdicating its responsibility to remove dangerous and adulterated products from the market. “Instead of protecting the public’s health and enforcing the law, they are digging in their heels,” said Dr. Cohen, who is also an internist at the Cambridge Health Alliance. “By not acting on BMPEA in the face of overwhelming evidence that it has no role in supplements and may pose serious health risks, the F.D.A. is sending a strong signal to all supplement companies: you may introduce hazardous new products with impunity.” O'Connor: Stop controversial supplements 2015
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA) USFDA: supplement regulation
Labeling, regulated by the FDA, does not really help distinguish between good and bad supplements. “It is a complete unknown when you are buying a dietary supplement, unless you have some proof of what is in that product — it could be anything,” Sarah Erush, Pharm.D., of the Children’s Hospital of Philadelphia tells FRONTLINE.
Supplements come in several forms, which include:
So, how can you take supplements without realizing it? A lot of processed food products, like fortified cereals for example, contain the same ingredients as supplements. Processing destroys the nutritional content in the food, so the manufacturers add synthetic nutrients so that they can claim that the product is healthy. Gupta: Supplement dangers 2015 Vitamins and minerals (when not consumed in food form) are classified by the Federal Drug Administration (FDA) as dietary supplements. Amino acids, botanicals, herbs, and substances such as enzymes, organ tissues and glandulars, and metabolites, are also classified as dietary supplements.
Difference between food & Supplements: the quality of nutrition in actual, fresh food varies greatly from the quality of nutrition in supplements. Supplements are made with synthetic nutrients that are made by manufacturing processes that do not resemble biological processes at all. They are not intended to replace the healthy food in your diet. Gupta: Supplement dangers 2015
Summary: there are several issues that need to be clarified, namely synthetic vs natural food supplements, vitamin bioavailability and co-factor impact on nutrients.
Synthetic vs natural food supplements: Many article writers, misinformed medical doctors and nutritionists claim that nutritional supplements are a waste of money and time and that these are not absorbed by the body. What these claims fail to clarify is the reason that synthetic supplements are bad.
The problem with vitamin-mineral supplements is that many vitamin and mineral supplements are chemically manufactured. Vitamin C is made from GMO corn [ synthesized as ascorbic acid ] while other B vitamins are made from toxic petroleum products in the laboratory synthetically with chemicals that do not come from their natural food sources. Thiel: Truth about vitamins
These supplements are made in a lab with the hope that these will mimic the way natural vitamins act in our bodies. Many synthetic vitamins lack the transporter substances and natural co-factors [ helpers ] associated with naturally-occurring vitamins and minerals. Most of these co-factor substances are unknown at this time. Wiki: other nutrients The result is that synthetic supplements are recognized by the body as toxins and excreted from the body.
Most of the essential co-factor substances are unknown at this time. We don't really know all the substances making up a natural vitamin, but the guess is that it could be 50 or more. As of 1996, over 3,800 different compounds had been identified in foods as having nutritional significance. Duke, James Textbook However, in a laboratory, twenty nutrients are about all that modern science can reproduce and put into a vitamin product made in a lab. Wiki: other nutrients The significance of this information is that we know very little about all the plant substances needed for health.
Vitamin bioavailability: Researchers in the past failed to account for the hidden co-factors in daily food that help ingestion of single vitamins, minerals and amino acids. Related to this failure was a failure to explain how the body functions and how nutrients really prevent certain disorders and diseases. For example, vitamin C when eaten as limes, was able to prevent scurvy in the days of sailing ships. Vitamin C had to have help from other co-factors, already present in other foods, to prevent scurvy, such as organic sulfur and calcium, although this has not been acknowledged by researchers. The false conclusion from such observation, that a single nutrient prevented a disease, carried over to viewing that a single nutrient could prevent a disease. Unfortunately, co-factors at that time were unknown. This single cause idea was also used in medicine to use a single substance to treat a medical problem; ignoring the need to treat the whole body as well as a single organ or tissue.
Likewise, niacin or vitamin B3 had to have help from other co-factors to prevent pellagra. Pellagra is a disease characterized by diarrhea, dermatitis and dementia. It occurs as a result of niacin [vitamin B-3] deficiency. Since tryptophan in the diet can be converted to niacin in the body, both of these need to be present to prevent pellagra. If left untreated, death is the usual outcome. But .... there may be unaccounted as yet other amino acid, vitamin and mineral co-factors. The best way to ensure that we get essential co-factors is from eating a balanced diet. But with mineral depleted soil, our food is fast becoming depleted in adequate and essential minerals. So, this link between nutrients and diseases will continue to be a dilemma until we identify all the co-factors in bioavailability. Since much of today's food is grown on depleted soils, we need to consider supplementing nutrient deficiencies by ingesting whole plant nutrient supplements. All nutritional supplements, especially when derived from whole plant foods, are good for the body as these have the plants enzymes essential for digesting the plants, as well as the essential co-factors in probably the proper dosage ratios.
Cofactors & Unknowns: The controversial comments about the shortcomings of previous nutritional research designs may be missing some really important information. Almost none of the research designs mention the impact that co-factors, whole-food complex, bioavailability and methylation may have on food ingestion, nutrition and wellbeing. None of previous researches identified the vitamins as organic or synthetic. Ignoring these determining factors when designing a research study would definitely alter the research results and result in misinformation. Sorochan: Cofactors 2015
Many research reports hide the nature of the vitamins that are used in their supposed double-trials
research and end up misinforming you and others about the real outcome of their tainted research.
Your feedback on this article is most appreciated. Thank you: E-mail author
Barron Jon, "Sympathy for the FDA," Natural Health Newsletter, 10/18/2010. Barron: FDA sympathy
Boghani Priyanka, "Can Regulators Keep Up with the Supplements Industry?" KBS Frontline, January 19, 2016. Boghani: supplement industry 2016
Childress Sarah, "Are Health Supplements Too Much of a Good Thing?" KBS Frontline, January 19, 2016. Childress: Health supplements 2016
Duke, James, Handbook of Chemical Constituents of Grasses, Herbs, and other Economical Plants, CRC Press, Boca Raton , 1992.
Editorial Board, "Distorting drug trials," The Guardian. Original article in Goldacre Ben, "Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes," BMJ, November 29, 2009. Goldacre: conflicts of interest
Goldacre Ben, "Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes," BMJ, November 29, 2009.Goldacre: conflicts of interest
Goldacre Ben, "Ghostwriters in the sky," The Guardian, September 18, 2010. Ben Goldacre: bad science
Goldacre Ben, "Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes," BMJ, November 29, 2009. Goldacre: conflicts of interest
Goldacre Ben, "Ghostwriters in the sky," The Guardian, September 18, 2010. Ben Goldacre: bad science
Gupta Sanjana, "The Hidden Dangers Of Supplements," IndianaTimes, June 4, 2015. Gupta: Supplement dangers 2015
Jaslow Tyan, "Consumer Reports: 10 hidden dangers of vitamins," CBS News, November 5, 2012. Jaslow: Hidden dangers of vitamins 2012
Moyer Melinda Wenner, "Nutrition: Vitamins on trial -After decades of study, researchers still can't agree on whether nutritional supplements actually improve health," Nature, 25 June 25, 2014. Moyer: Controversy over vitamins 2014
Newman Nathan,"Big Pharma, Bad Science," The Nation, July 25, 2002. Newman: Big Pharma, Bad Science
O'Connor Anahad, "Retailers to Stop Sales of Controversial Supplements," NewYork Tines, Well: ALTERNATIVE MEDICINE, April 9, 2015. O'Connor: Stop controversial supplements 2015
Sorochan Walter, "Cofactors and coenzynes," November 10, 2015. Sorochan: Cofactors 2015
Sorochan Walter, "Vitamin-Mineral Supplement update" Octover 1, 2013. Sorochan: Vit-Min Supplement update
Taddonio Patricia, "Supplements, What’s Really in the Bottle?" KBS Frontline, January 19, 2016. Taddonio: What's in bottle? 2016
Thiel Robert, "The Truth About Vitamins in Nutritional Supplements," Doctor's Research. Thiel: Truth about vitamins
UCLA, A newsletter for UC friends and advocates, January 08, 2002. a href="http://www.universityofcalifornia.edu/news/article/3849">UCLA observation
USFDA, "Dietary Supplements." USFDA: supplement regulation
Wikipedia, "B vitamins. Wiki: other nutrients
Worth Katie, "Five Questions To Ask When Considering Health Supplements," KBS Frontline, January 19, 2016. Worth: Questions about supplements 2016