August 1, 2012

12 Min Read
Consumer Reports Identifies 10 Supplement 'Hazards'

HARLAN, IowaConsumer Reports took another swipe at the dietary supplement industry with its September 2012 cover article "Vitamins & Supplements: 10 Dangers that May Surprise You." The magazine said it identified 10 hazards distilled from interviews with experts, published research and its own analysis of adverse event reports (AERs) submitted to FDA.

However, John Shaw, executive director and CEO, Natural Products Association (NPA), said Consumer Reports was using this as an opportunity to fear monger.  He called the article "another smear campaign against dietary supplements." He said data from the government shows supplements have an excellent safety record, especially considering the millions of supplements sold annually. "Nothing in Consumer Reports should convince anyone to stop taking their supplements," he said.

Steve Mister, CRN president and CEO, Council for Responsible Nutrition (CRN), noted that while it's never good for the industry to have these kinds of negative articles, the article has constructive aspects. "It is certainly hyped, over sensational and an easy jab at the industry, but there are some positive shout outs to the industry," he said, noting it gave advice CRN normally gives consumers, such as talking to health care practitioners about supplements, reading product labels, researching using objective websites and avoiding products that make overpromising claims.

Duffy MacKay, N.D., vice president, scientific and regulatory affairs, CRN, noted that many supplement consumers are savvy and going to realize the hazards posed in the article don't apply to them. "Consumers have found companies they know and trust, and they feel the benefits of the products they take," he said. "When they see this rhetoric about avoiding tainted products, avoiding mixing some supplements with prescriptions and avoiding overdosing, the half of Americans that take supplements, are going to realize that this doesn't relate to them. If you're doing those things, this article doesn't raise red flags for you."

The 10 "hazards" pointed out by Consumer Reports were:

1. Supplements are not risk free

The article reported FDA has received more than 6,300 supplement AER reports from 2007 to April 2012. These reports described more than 10,300 serious outcomes including 115 deaths and more than 2,100 hospitalizations, 1,000 serious injuries or illnesses, 900 emergency room visits and some 4,000 other important medical events, according to Consumer Reports.

The article noted FDA gets far more reports from prescription medication, but quoted Pieter Cohen, M.D., internist at Cambridge Health Alliance in Massachusetts, who said the benefit of prescriptions outweigh those of supplements. He said drugs save lives, but supplement "rarely, if ever" save lives.

The article also quoted Daniel Fabricant, Ph.D., Director of FDA's Division of Dietary Supplement Programs, as saying FDA suspects most supplement problems never come to the agency's attention.

The article also said current laws make it difficult for FDA to order a problem product off the market.  Mister disagreed, however. "FDA has recall authority, the ability to issue seizures and injunctions (as we've seen recently in GMP cases), the ability to remove products that present a significant risk of illness or injury (as it did with ephedra), the ability to demand companies reformulate products as it did a few years ago with hydroxycut."

2. Some supplements are really prescription drugs

Fabricant said supplements spiked with prescription drugs are the biggest threat to consumer safety. Since 2008, more than 400 products have been recalled for this reason. Most of these products fall into the bodybuilding, sexual enhancement and weight loss categories, according to the article. Many products contained same or similar active ingredients as prescription drugs, such as silenafil (Viagra), tadalafil (Cialis) and sibutamin (Meridia, a weight loss drug that was withdrawn from the market because it increases the risk of hear attacks and stroke).

Mister said adulteration is a serious problem for those consumers who unwittingly take drugs they think are supplements, but that doesnt mean the problem is widespread.

3. You can overdose on vitamins and minerals

"Unless your health care provider tells you that you need more than 100-percent of the recommended daily intake (RDI) of a particular nutrient, you probably don't," the article says, adding megadoses of fat-soluble vitamins A, D, E and K can "cause problems."

Consumer Reports makes the obvious points that nothing is risk-free and too much of anything is not necessarily a good thing," said Cara Welch, senior vice president of scientific and regulatory affairs, NPA. "Furthermore, it relies on disputed and inaccurate studies to draw the wrong conclusions. Consumers deserve better."

MacKay noted RDIs are public health numbers that target the entire population. "It's a conservative number to make sure everyone is meeting their needs," he said. "There is all sorts of individuality within that. In speaking with nutritionists/dietitians/health care providers and looking at the diet, you will find many cases that would change an individual recommendation and push it higher than an RDI."

MacKay added vitamin and mineral overdose is almost nonexistent. "Acute poisoning of vitamin and minerals just doesn't happen," he said. "The bigger concern is the long-term higher intakes, and upper limits (ULs) are there to instruct people on the doses to avoid."

4. You can't depend on warning labels

Consumer Reports told readers iron is the only supplement that requires a warning label. However, some companies choose to add warnings to other supplements. Consumer Reports said all 15 iron supplement they reviewed carried the required warning label. Of the 233 other warning labels they reviewed, the magazine said most were general warnings, but others offered drug interaction and health condition warnings.

Mister was quoted in this section of the article as saying some companies offer an overabundance of caution, but other companies don't warn consumers of things that aren't likely to be a concern.  

Mister explained to INSIDER that product warning labels are largely driven by product liability litigation. "Companies end up developing warning labels based on wanting to protect consumers and avoid private litigation," he said. "The law appropriately allows a great deal of flexibility there."

5. None are proven to cure major diseases

Consumer Reports said supplements are not allowed to claim they cure, diagnose, mitigate, treat or prevent diseases per U.S. law.  The article noted FDA has sent dozens of warning letters to companies for such claims since 2007.

Supplements are foods, not drugs," Shaw reminded. "If a product makes disease claims or includes a drug, then its not a supplement. The legitimate supplement industry, who we represent, wants the criminals selling these illegal drugs out of business."

Mister added, "Most consumers understand that supplements are just that; they supplement the diet. They are not intended to be substitutes for drugs. They don't call them dietary substitutes."

6. Buy with caution from botanicas

Botanicas, stores that sell traditional medicinal plants, are often found in Hispanic neighborhoods, according to the article. Consumer Reports said it sent a Spanish-speaking reporter to one in New York who obtained "incomplete information and bags of mystery herbs." The reporter asked for advise on treating type 2 diabetes, high blood pressure and impotence. The magazine said healers at the botanica gave herbs and instructions, but said all lacked scientific evidence.

MacKay called botanicas "gloried flee market settings with unqualified people giving advice," and said  most consumers go to a store with a brand and reputation to protect, buy from brands they know and trust, and speak to a health care provider about what they are taking and why.

Shaw added, Misleading stories like this one are especially unfortunate because they can hurt the mom and pop stores that sell natural products and supplements in communities across America. Tens of thousands of Americans depend on this industry for jobs. They are dedicated to supporting the healthy lifestyles of millions of people."

7. Heart and cancer protection: not proven

The article said recent evidence shows omega-3s may not reduce the risk of heart disease and antioxidants may not reduce cancer risk. And it mentioned the recent study that reported calcium supplementation increased heart attack risk.

However, Welch pointed out the American Heart Association (AHA) recommended a diet high in omega-3s and supplementation for those who cannot get enough from their diet. "In addition, the federal government itself has approved health claims for supplements, such as associating vitamin D and calcium intake with a reduced risk of osteoporosis."

Mister said Consumer Reports offers incomplete information on the research.  " They get some of these studies wrong because they go for the high-impact headlines." he said, pointing out the omega-3 study the article references had flaws, which CRN addressed when it was released. 

"In the science area, they dedicate two paragraphs to cover an area that has thousands of clinical trials, both on calcium and omega-3s," MacKay noted. "With calcium for example, the Institutes of Medicine (IOM) has reviewed the science and recommended 1,000 to 1,300 mg for women from food and supplements. To write two paragraphs and point out one study that says there's a problem is disingenuous to science."

In a letter it submitted to Consumer Reports, the Global Organization for EPA and DHA Omega-3s (GOED) requested the magazine revise the section on omega-3s and publish a correction in the next issue.

The organization said the article's conclusion that  fish oil doesn't help the heart based on a flawed study is inaccurate and irresponsible. "Consider that the list of long-chain omega-3 recommendations from professional scientific organizations and governments continues to grow because the cardiovascular benefits associated with EPA and DHA are so compelling," the organization wrote.

GOED also took issue with the article saying most people can get enough omega-3s by eating fatty fish.  "For 2005, in the United States alone, scientists from the Harvard School of Public Health estimated that low omega-3 polyunsaturated fatty acid intake accounted for 72,000-96,000 deaths from cardiovascular disease (PLoS Med. 2009 Apr 28;6(4):e1000058)," the organization wrote. "Clearly, there is a disconnect when you include as part of your mission 'to empower consumers to protect themselves,' yet you blatantly mislead them by not presenting the totality of the scientific evidence, as well as downplaying the benefits of omega-3s."

8. Chocking

The article said choking was a serious symptom that showed up in AERs with more than 900 reported cases. However, the article quoted a doctor as saying actual chockingwhen a pill goes down the windpipeis rare. He said pills are likely irritating the esophagus, causing a muscle spasm. He added more water usually fixes the problem.

Shaw said someone could choke swallowing anything, not just supplements. "This is another example of fear mongering by Consumer Reports, and using this issue as an argument against taking supplements is insulting to consumers."

9. Some natural products are anything but

Consumer Reports said vitamins can be synthetically produced, and noted the warning letters FDA sent to 10 manufactures of DMAA. The article said FDA warned the companies that synthetic DMAA is not a legal dietary ingredient.

Mister pointed out that DMAA is a complicated issue that can't be explained in a couple of paragraphs. "DMAA has a lot of other issues around it, only the first of which is if it's sourced from geranium," he said. Then, he said there are questions about how companies source their DMAA (from geranium or synthetically produced) and what kind of safety studies they have. "Then, it gets into the whole new dietary ingredient (NDI) issue, which is not even what this piece pretends to be about," he said. "It's a matter of trying to take a complicated issues and boiling it down."

10. You may not need supplements at all

The article said a good diet eliminates the need for supplements, and it offered its take on five top-selling supplements. It said few people are deficient in vitamin A and B vitamins, and said exposing one's self to sun and eating vitamin D-fortified foods can reduce the need for a vitamin D supplement. It said some evidence shows vitamin C may improve cold symptoms and vitamin E may increase mortality. And studies on multivitamins, the report said, have not shown a great benefit.

Mister said CRN disagrees with the multivitamin conclusion because large clinical trials are lacking. "We disagree when they say that large clinical trials have found they don't work. That is incorrect because there isn't that much data out there."

Welch noted research shows supplements can address nutritional deficiencies and improve overall health. "Getting an adequate amount of nutrition from the diet is ideal, but unfortunately, many Americans are not getting the nutrients they need from the foods they eat."

INSIDER's Take

Consumer Reports is a known antagonist of the dietary supplement industry. In 2010, the publication released a cover story about " 12 dangerous supplements," which was an update from a 2004 list of "dirty dozen" supplements. Industry members argued most of the supplements on the lists were uncommon and the entire list accounted for less than 1 percent of the supplement market. INSIDER senior editor Steve Myers explored this issue in the article " The Media Holography." In January 2012 Consumer Reports issued a correction after it used an inadequate test to determine fish oil products weren't fresh.

The magazine seems to use these supplements-are-bad stories to get people to buy the issue and click on the story online. About once a year, Consumer Reports attacks the industry. However, as Mister and MacKay pointed out, there are some truths in the article.

But, as a whole, the article has a negative take on the supplement industry.  It's up to supplement manufactures to educate their consumers about the benefits of supplements and how to choose products that don't pose the 10 "hazards" Consumer Reports highlighted. Smart customers will understand that the magazine is sensational to grab readers, and most likely, this article won't affect supplement sales.

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