Annual USA sales of nutritional supplements top $23 billion, but where's the quality control?

June 27, 7:04 PMSacramento Nutrition ExaminerAnne Hart

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Pet food and human nutritional supplements have something in common: both are multi-billion dollar businesses in the USA. But where’s the quality control and lab testing with free information accessible to consumers on either of those industries?

USA annual sales of nutritional supplements exceed $23 billion. But the Food and Drug Administration (FDA) is spread thin and doesn’t have the money, resources, or staff to test all the supplements.

 In comes the private testing labs to fill the gap by testing and then selling reports on the test results. But the labs charge consumers fees to read those lab reports on the quality of various nutritional supplements and related skin-care products.

Shouldn't the lab charge fees to distributors that directly sell the nutritional supplements to the public online or from stores instead of charging consumers fees to find out whether there is lead or other heavy metals in specific brands of supplements? That information should be in a free online database or in public libraries so anyone can instantly find out whether specific supplements or packaged health foods such as various brans contain lead, arsenic, aluminum, mercury, or other toxins.

The FDA can't tell you whether there are insects in that package of cereal or bulk bag of quinoa you just bought from a health food store. Someone should be able to let the public know whether specific supplements have toxic metals. And the information should be free to the consumer with the store owners and manufacturers paying the fees to the testing labs and report-generating firms. The point is this information should be free to consumers that buy the products.

Margaret A. Hamburg, is the new commissioner of the Food and Drug Administration. She has a job cut out for her: reorienting the FDA into the key federal agency that protects public health. Today a House committee considers a new bill.

If passed, the legislation would give FDA broader powers to regulate food safety. Will House leaders pass the bill this year? The bill would place greater responsibility on the food industry to prevent food-borne illnesses. If the bill passes, it would require the FDA to significantly expand its inspection and oversight of the food and drug industry. But where’s the money coming from to oversee the testing of nutritional supplements and make sure they’re safe for consumer’s consumption?

Even if the bill passes in the House, if the FDA still finds itself short on resources to test supplements, how can consumers help? Can consumers ally themselves with the labs doing the independent testing of the supplements and also get the manufacturers on board?

Can the government, manufacturers, consumers, and testing labs all work together as a team focused on consumer health? Volunteers following safety research and testing are different from manufacturers following the money. Do we get students involved in public interest research groups dedicated to validating safety studies of supplements? On whose side are the manufacturers whose goal is to make sure consumers keep buying the products after independent testing?

Are manufacturers supplying the testing labs with the exact same products consumers are buying rather than samples full of substitutions submitted for testing? Testing labs are doing right by buying the products available to consumers.

Besides nutritional supplement sales in the USA, many people order Ayurvedic supplements from India and other countries to use as alternative treatments instead of prescribed drugs for common ailments of aging such as enlarged prostate, or to escape side effects of prescription drugs. Others are buying minerals for family use that contain too high levels of lead.

Somebody has to make sure that there is no more than 0.5 micrograms of lead in your daily dose of magnesium, that your herbs are not full of toxins or heavy metals, and that your rice bran is safe from arsenic or vermin contamination. Why is it that when an herb such as olive leaf extract is ordered from a specific vitamin company outside California, that it comes in the mail with a warning note that it may contain carcinogenic products?

Trade associations say the new FDA rules protect consumers by ensuring that companies can be seized and their owners sent to jail if they sell adulterated nutritional supplements to the public. But independent labs that test the same supplement products that consumers buy inform consumers that the FDA doesn’t scrutinize nutritional supplements in the same way that the FDA acts toward over-the-counter and prescription drugs.

Only serious problems with nutritional supplements are required to be reported to the FDA. Is the safety of your family’s nutritional supplements largely in the hands of independent testing labs such as ConsumerLab.com, unless you have access to specific scientific journal reports?

The FDA estimates that more than 50,000 safety problems a year are related to supplement use. Consumers can read information published by the Institute of Medicine, an independent science panel that advises the government. Four years ago the Institute of Medicine studied the quality and safety of dietary supplements and found low product reliability. Who’s protecting the consumer if laws aren’t tightened?

There’s a group that protects consumers called the Council for Responsible Nutrition. Maybe it’s time for a consumer’s quality control volunteer group that’s not spread too thin to make sure that adulterated products are brought to the attention of the consumer as well as the FDA. Such a group could act as a bridge between the independent testing lab, the consumer, and the FDA.

According the the Council for Responsible Nutrition's site, "The Council for Responsible Nutrition (CRN), founded in 1973 and based in Washington, D.C., is the leading trade association representing dietary supplement manufacturers and ingredient suppliers. CRN companies produce a large portion of the dietary supplements marketed in the United States and globally."

The  Council for Responsible Nutrition has member companies that manufacture popular national brands as well as the store brands marketed by major supermarkets, drug store and discount chains. According to the site, "These products also include those marketed through natural food stores and mainstream direct selling companies."

In addition to complying with a host of federal and state regulations governing dietary supplements, the 70+ manufacturer and supplier members of the Council for Responsible Nutrition also "agree to adhere to voluntary guidelines for manufacturing, marketing and CRN’s Code of Ethics."

Where's a group for responsible nutrition run by members that are consumers rather than manufacturers to oversee the manufacturers? You have a government agency, the FDA with limited resources, and you have a group of manufacturers. What about forming a group of consumers that would watch the government agency, the independent testing labs, and the manufacturers?

What such a group would need to do is to start a free informational clearinghouse that can help consumers find products not contaminated. It’s time for manufacturers to become involved together with consumers and with the independent testing of the same products consumers buy.

That's why labs that test supplements such as Consumer Lab.com report that they buy the same packaged product that consumers buy. Still, you need a group representing the consumers to validate and verify what labs, manufacturers, and government actually do.

So far, that's left to universities that test products as part of research and report findings in medical journals. And a consumer's group needs to watch those sources as well, since some research studies carried out in universities are funded by the manufacturers. Basically you have to ask who's watching the watchers and reporting independently and objectively to consumers.

When consumers ask where herbs or ingredients in supplements originate, manufacturers, in some cases tell the consumer that they don’t reveal the source of their herbs or other ingredients. Industry will tell you that contaminants in supplements are the exception.

According to the Associated Press article published June 9, 2009, “Tests show many supplements have quality problems” by Marilynn Marachione, AP Medical Writer. “One quarter of supplements tested by an independent company over the last decade have had some sort of problem. Some contained contaminants. Others had contents that did not match label claims. Some had ingredients that exceeded safe limits. Some contained real drugs masquerading as natural supplements.”

Although in 1997 FDA passed laws that allowed the FDA to write quality control rules for products sold in the USA, that law lagged behind all these years until finally being adopted this year. What’s missing from the rules are standardized laws or rules that gives directions to the companies that test the manufacturer’s products and tells them what to do in order to prove what is in a manufacturer’s product.

If the supplement manufacturers substitute other ingredients when a product is tested, the laboratory could be fooled. The FDA rules in place now don’t have standardized limits on a wide variety of toxins that are showing up in nutritional supplements and herbs that are sold to the public. For example, independent testing labs found lead in magnesium supplements sold to the public.

There aren’t enough limits on toxins such as lead in nutritional supplements. Any new FDA rules still don’t change the fundamental way supplements such as minerals, vitamins, and herbs are sold to the public.

Are you getting tired of finding lead in your magnesium citrate powder and in your ginkgo pills? Are you fed up with the arsenic in herbals? Maybe it’s the insects in your baby's food that annoys you. Or could it be the prenatal vitamins reported in scientific journals to be short on what’s reported on the label?

When you complain, you’re told that toxic metals and parasites are part of nature and that’s why they’re found in ‘natural’ products. Worse yet, are news articles that mention studies but are too space-challenged to give you the name of the study so you can look it up online or in a university or public library scientific journal.

The question is not whether the vitamins make you healthier, but whether they’re safe. You don’t really know what’s in that container. All you can do now is rely on private labs that consumers have to pay to access information, unless you go directly to the researchers and read reports already published in scientific journals.

FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed.

The U.S. Food and Drug Administration (FDA) is enforcing the laws that protect consumers from illegal products marketed through the Internet that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus. Manufacturers need to remember that it is against the law to advertise any product that says on the label that the product is intended to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus (or any other disease) that have not been cleared, approved, or authorized by the FDA.

That means if you advertise with a label on an orange saying that the vitamin C in that orange will cure scurvy, it's against the law because your food item now becomes a drug. And only a drug is supposed to mitigate, prevent, treat, or cure a disease or affliction. And the orange has not been approved by the FDA as a drug. So you can't say it can cure or prevent any affliction.

That's how supplements are sold as foods, not drugs (because only drugs can treat or cure). Supplements contain the notation on labels that read, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Yet everyone knows consumers buy supplements to prevent or treat what ails them in order to escape the sometimes adverse, allergic, or dizzying side effects they've had from prescription drugs. The reason people buy supplements is to have a better quality of life. Consumers also want a safer quality of supplements and foods. People buy supplements also out of fear.

Consumers want improved quality control of the non-drug nutritional supplements they buy. And they want to know why in some nutritional supplements drugs have been found by independent testing labs instead of the natural food-derived ingredients that are printed on the label.

For more detailed information, see the FDA's report, New Dietary Ingredients.  To help consumers in their search to be better informed, FDA is providing the following sites: Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information (includes information on how to evaluate research findings and health information on-line) and Claims That Can Be Made for Conventional Foods and Dietary Supplements, (provides information on what types of claims can be made for dietary supplements). Regarding ingredients required to be listed on a label, see Federal Register Final Rule - 62 FR 49826 September 23, 1997.    

How Would You Like to Have a Say in the New Food Pyramid?

Shouldn't an impartial, qualified third party design the Food Pyramid? The Department of Agriculture, for example, is in charge of designing and updating the Food Pyramid that appears all over the USA in most school textbooks, on signs displayed in healthcare centers, and prominent in publications on nutrition.

The function of the Department of Agriculture is to promote the agricultural products of the USA and to offer guidance to consumers. Here, the issue and conflict of interest is caught between the responsibility of the Department of Agriculture to offer nutrition-related guidance and the Department of Agriculture’s economic interest.

The conflict of interest is one of commitment. Is the Department of Agriculture committed to supporting its own agricultural-economic interests or committed to offering unbiased nutritional guidance? Who should be in charge of designing the Food Pyramid?

When a consumer looks at the latest revision of the Food Pyramid, the first item noticed is the lack of guidance on what particular food items should be emphasized, and which items should be eaten in very small amounts. What’s controversial about the new Food Pyramid is that information is missing about what foods should be eaten more and which foods should be eaten less. See the 2010 food guidelines at The Dietary Guidelines for Americans site.

According to the site, The Dietary Guidelines are jointly issued and updated every 5 years by the Departments of Agriculture (USDA) and Health and Human Services (HHS). They provide authoritative advice for people two years and older about how good dietary habits can promote health and reduce risk for major chronic diseases.

How to Provide Your Comments to the Dietary Guidelines Committee

The 2005 Dietary Guidelines remain the current guidance until the 2010 Dietary Guidelines are published. You even can  provide comments to the Committee. Written public comments can be submitted continuously throughout the 2010 Dietary Guidelines revision process.

To submit or view written public comments, at the bottom of The Dietary Guidelines site, there's a 'submit' icon. When you provide your original comments to the Committee, don't make any comments or attach any documents that would violate copyright laws. As far as the design of the Food Pyramid, a small figure that could be interpreted as doing exercise has been added to the current Food Pyramid that has appeared since 2005.

Do you want that figure changed for the 2010 Dietary Guidelines? The public has some say in the matter. So leave any comments at The Dietary Guidelines site, if you have some great suggestions.

Instead of illustrating what foods to emphasize, the still current (but only until 2010) Food Pyramid that first appeared in 2005 directs the eyes to a figure walking uphill. At first glance, the consumer may understand exercise is good, but how much? No guidance is given as exercise is individualized.

Which food items should be emphasized? This too, must be individualized, customized, and tailored to one’s metabolism and even one’s genetic signature—about which the average consumer probably would not immediately think when briefly glancing at the Food Pyramid. However, the mission of every new Food Pyramid is to give guidance on nutrition.

Another question is: how does the Food Pyramid guide those on special diets? Economic trends are what influence the design of nutrition programs. Conflicts of interest between economic, political, and scientific forces may shape the design of studies, charts, tables, and research.

When will the food industry remove the dangerous neurotoxin, MSG from packaged, canned, and restaurant food? Will restaurants also reduce the amount of salt they dump into soups and other foods?

Monosodium glutamate (MSG) is mistakenly used as a taste enhancer on usually overcooked or 'tired' foods that don't have left enough flavor because they've been stored a long time. Up to  40 percent of the USA population is allergic to MSG. See the articles, studies, and bibliography for reference on adverse reactions related to MSG in food at the Truth in Labeling site. Also see the article, "Monosodium Glutamate: Poison the Body to Better the Taste," at the World Wide Health Center Net site.

According to the Truth in Labeling site, "On March 13, 2009, President Obama stated, in part, that the nation’s decades-old food safety system is a 'hazard to public health.' While nominating Margaret Hamburg, M.D., the former New York Health Commissioner, for the position of FDA commissioner, he also indicated that he would be creating a Food Safety Working Group to coordinate food safety laws throughout government and to advise him on how to update them."

There are healthier, natural alternatives to MSG. Lemon, orange, cherry, or lime juice would be a better flavor enhancer. Even cooking with a small amount of organic wine (without added sulfites) is safer. MSG secretly addicts the consumer to the food by tricking the brain into thinking the food is more flavorful as it hits the taste buds on the tongue. The hidden goal is to make sure the consumer will return to the product or restaurant and order the same food again.

Instead of MSG, as a flavor enhancer, use natural, fresh food flavors, stock, or add a small amount of healthier spices, vegetables, or fruit juices without overpowering the aroma and flavor of the food. MSG is dangerous to the central nervous system. A long list of books have been written about its neurotoxicity. For your reference, a bibliography of 62  studies on the toxicity of MSG are listed at the bottom of the article, "This is What the Data Say About Monosodium Glutamate Toxicity and Human Adverse Reactions," compiled by Adrienne Samuels, Ph.D. May 2009.

You'll find MSG in salad dressings, a variety of restaurant foods, in several types of canned soups and vegetables, in various types of prepared fish or meat products, and in some bottled or canned savory sauces. Read the label before you buy the product because it's often hidden in foods you'd never think would contain MSG.

Why is MSG still listed at safe by the FDA? Will the Department of Agriculture and the FDA ever share information and connect, commit, and communicate better regarding what additives are being put in most foods? Related research is abundant.

Now you have a sounding board. Your comments will be accepted by the Department of Agriculture's Dietary Guidelines site regarding the new Food Pyramid coming out in 2010. What do you think the new guidelines might tell consumers? What would you tell the Committee?

On one side of the issue, (which would make a great debate) the Department of Agriculture is thought of by some academics and critics to be in need of a crisis public relations campaign because of its focus on nutritional politics and economics causing conflicts of interest. That main conflict is between giving guidance and serving economic interests.

From the other side of the issue, consumers see a new Food Pyramid emphasizing exercise instead of emphasizing which particular foods should be consumed in larger or smaller amounts. The main issue is: Should the same group that designs nutritional visuals offering public advice also be required to promote and publicize huge numbers of agricultural products of the USA? Or should the promotion of USA-grown agricultural products be handed to a marketing and advertising agency?

Other political issues in nutrition focus on the competition between vegetables and fruits grown in the USA and the competing proliferation of edible imports from other lands seen in the larger, chain supermarkets. Issues also include questions as to what pesticides that are banned in the USA were used in other lands, or what type of bacteria may be on the green onions or sprouts from a location commonly using human waste as fertilizer.

A division of labor appears to be what consumers hope will avoid those conflicts of interest. As to the new Food Pyramid, current information about what products and produce are healthiest to emphasize and in which amounts are what consumers and nutritionists would like to see.

Politics are dependent upon economic forces driving the various interest groups and agencies in power. Controversies arise when interests clash. Whether public interest groups clash over nutrition guidance or cultures clash over habits, behind the conflict of interest is the politics of economics.

Another important political issue in the field of nutrition is the debate about which types of food are healthiest. The food table published by the government’s Department of Agriculture includes carbohydrates, fats, and proteins.

The reason why fat becomes a political issue is because not enough information is provided in the newest food table published by the Department of Agriculture concerning which sources of proteins, fats, dairy products, and grains are healthiest. 

 Here is a list below of some of my other articles on nutrition and health. Usually, at least one new article is added daily. Check the archives at my home page for additional articles.   

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