Category : Supplements

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NOW Foods Responds to “Dangerous Supplements” Article

Courtesy of NOW Foods

The September 2010 Consumer Reports article entitled “Dangerous Supplements” highlights 12 dietary supplements the authors claim are potentially dangerous. This article has led to numerous news stories that have aired on national TV programs. However, supplement maker NOW Foods believes these stories contain inaccurate and misleading information. This may well discourage consumers from availing themselves of the benefits that nutritional supplements convey, and needlessly raise the specter of danger.

Consumer Reports and the related media stories refer to the supplement industry as operating with little FDA [U.S. Food and Drug Administration] oversight. The reality is that the supplement industry is regulated by the FDA, with manufacturers being audited by the FDA to ensure they meet cGMP requirements (Good Manufacturing Practices). The FDA also regulates labels: all claims must be truthful and not misleading, all ingredients must be listed on the labels, and companies must have documentation to prove claims that must be maintained. Any new supplement ingredient introduced must go through a vetting process with the FDA before it can be legally marketed, similar to the FDA drug approval process in terms of demonstrating safety.

Numerous FDA commissioners have stated that they do have ample authority to regulate the supplements industry – they just don’t have the resources. This is why the industry has long, and very loudly, supported legislation to give FDA more resources to crack down on the fringe companies that do not follow the laws regulating the industry. Also, the FDA has the legal authority to remove from the marketplace any dietary ingredient that they determine to be dangerous.

Supplements have a proven track record of safety, in fact a much better track record than pharmaceuticals, over-the-counter (OTC) medicines and even common foods. For example, the most recent annual report of the American Association of Poison Control Centers published in the Journal of Clinical Toxicology reported zero accidental deaths from dietary supplements. Consumers should be more concerned about acetaminophen adverse events, which cause a large number of deaths (estimates vary widely, but usually range between 3,500 and 10,000), liver failures and ER visits annually.

Additionally, most of the herbs listed in the article are not widely available, and certainly not sold by the vast majority of the industry. To broadly characterize dietary supplements as dangerous on the basis of a handful of products that they claim may be potentially unsafe, is sensationalism that discredits the proven safety record of this product category and fails to recognize that millions of Americans choose to take supplements every day because they derive significant benefits from them.

In a related article, Michael McGuffin, the head of the American Herbal Products Association (AHPA) had this to say.

Supplement Caucus Capitol Hill Briefing


WASHINGTON—The Congressional Dietary Supplement Caucus (DSC) held a briefing on June 23 to inform our representatives about the important role of supplements in the shifting from reactive health care to a more preventive and wellness system. Held in conjunction with the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), the luncheon briefing featured a presentation from David Grotto, RD, LDN, founder and president of Nutrition Housecall, and advisory board chair for the Produce for Kids® and PBS Kids™ health initiatives, who stressed dietary supplements are an important part of a well-rounded nutrition program, particularly for those who don’t get all their nutrients from food alone.

“We know that a healthy diet and lifestyle, along with appropriate dietary supplements, can really make a difference in helping to mitigate health problems, such as heart disease, cancer and stroke” Grotto said, adding many people have “lost touch” with the purpose of food and are not meeting the Dietary Guidelines. “We don’t always necessarily eat the best every day of the week, so it does make sense to include some responsible dietary supplements along with that.”

Rep. Jared Polis (D-Colo.), DSC co-chair, also spoke to attendees about the role of supplements in health and wellness, noting education on healthier lifestyles and diet can ultimately lead to reduced health care costs. “Supplements used properly help prevent disease and promote good health as part of an overall healthy lifestyle,” he said, noting “scientific evidence strongly suggests that the use of daily dietary supplements would be an effective way to address nutritional gaps” in deficient populations.

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‘Mixed bag’ Ruling from European Court on French Vitamin Case

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An important ruling was handed down by the European Court of Justice on 29th April 2010. 

The ruling relates to a case brought by the vitamin company, Solgar, and a range of other food supplement interests challenging decisions by France to set highly restrictive maximum levels for vitamins and minerals prior to the European Commission’s planned EU-wide harmonisation of Maximum Permitted Levels (MPLs).

Read the full ruling.

In a nutshell, the European Court of Justice has further cemented a fundamentally flawed approach to risk management, which is in the process of being developed for EU-wide implementation by the European Commission.  There is however, the glimmer of a silver lining, at least around parts of the Court’s judgement.  Probably the brightest light comes from the Court’s decision to bar either national governments or, by inference, the European Commission, from implementing excessively low maximum levels without demonstrating any “genuine” or “real” risks to human health.  We feel that this ‘supreme view’ from the highest court in Europe could pave the way for preventing disproportionate bans on particular molecular forms of nutrients that are known to be safe (and beneficial) at supplemental doses currently used.

Following is a more in depth response by ANH to the ruling.

The ruling is a mix of good and bad.

What’s bad about it?

Unsurprisingly, the ECJ ruling reinforces the principles for the establishment of maximum permitted levels (MPLs) that are written in to Article 5 of the Food Supplements Directive (2002/46/EC).

However, these principles on which MPLs are to be set have not been established using proper scientific methods, nor have they been validated against real data on beneficial or harmful intakes.  But of course the ECJ judges are not scientists and they are simply following the law, not appreciating its scientific weaknesses.

For more about the scientific weaknesses, please see:

Verkerk RH, Hickey S. A critique of prevailing approaches to nutrient risk analysis pertaining to food supplements with specific reference to the European Union. Toxicology. 2009 Dec 23. [Epub ahead of print]

Verkerk RH. The paradox of overlapping micronutrient risks and benefits obligates risk/benefit analysis. Toxicology. 2010 Feb 24. [Epub ahead of print]

The most disconcerting aspect of the ruling is that it sets the scene for highly restrictive MPLs, and even outright bans on nutrients if MPLs are computed at the zero level.

And what’s good about it?

The plus side of the ruling is that the ECJ has picked the plaintiffs’ question about the anomaly of fluoride and the French authorities decision to issue a zero level, based on the fact that it is  not possible to predict intakes from other sources, and total intake from sources other than supplements might exceed the known upper safe level (UL). While this makes total sense for fluoride in supplements, which can cause significant harm particularly in children, it does not make sense for many other types, or molecular forms, of nutrients for which harm at supplemental levels has never been demonstrated.

Another useful element of the ruling (paragraph 55) is that it puts the onus on national authorities to prove that any restriction of dosages is based on an ability to demonstrate a “real risk” to public health. This is a reiteration of the point made by the ECJ in our own case of 2005 (paragraph 73). This principle will obviously also apply to the the Commission’s proposed harmonised imposition of MPLs and could set the scene for legal challenge if the levels are excessively restrictive for a given molecular form of a nutrient for which no risk at that level can be demonstrated.

In paragraph 61, the court paves the way for labelling to be used as a means of protecting specific, minority groups within the population, such as children, pregnant women, etc. While the ruling specifically applies to national rules implemented by Member States prior to the EU-wide harmonisation of MPLs, the ECJ’s ruling will likely have a legal impact on the approach to harmonisation as being considered presently by the European Commission.

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You Depend On Your Health Freedoms – And We Depend On YOU

We at Citizens for Health are working around the clock to alert you about threats to the health freedoms we currently enjoy; to provide opportunities to fight back against those threats; and to organize the natural health community into a force for expanding our rights as consumers. Some of the more recent threats to these rights have focused on limiting access to the supplements we rely on to maintain our health, expanding the FDA’s regulatory authority over food (including supplements), and the censorship of the truthful, science-based information we need to make informed decisions about our health.

Over the past few weeks you’ve received a number of action alerts about these, and other, issues. Thanks to the thousands of you who have responded to these alerts and participated in our grassroots efforts to preserve your health freedom rights, some of these threats have been held at bay. However, we must remain vigilant and organized – those opposed to your rights as a consumer will exploit any opportunity to advance their oppressive agenda. Citizens for Health is on the front lines of this fight and we won’t rest until we are all free to make our own informed decisions about maintaining our health and about what we eat and drink. Such diligence requires resources, and that is why we need to urge you to turn the same commitment and zeal you’ve shown in responding to our action alerts toward supporting our work in another way.

Today, more than ever, we need your financial support in order to continue our role as the watchdog on issues affecting the natural health consumer. It’s no secret that opponents of health freedom – from pharmaceutical companies seeking to discredit the science behind supplements to the enshrined medical establishment eager to increase its stranglehold on consumers nationwide – have vast resources to dedicate to maintaining the status quo. However, we have an important resource they don’t – you.

Currently, we are the only consumer-based grassroots advocacy organization representing the interests of the natural health consumer, and our ability to do what we do is directly related to the budget that is available to us. With the recent barrage of attacks aimed at the natural health community, it’s more important than ever to develop a war chest of resources that will help us protect these valuable rights.

The success we’ve enjoyed in defending your rights would not have been possible without the generous financial help from our supporters going back to 1993 and our campaign to pass DSHEA. Click here to help us ensure similar success for years to come by making a donation today, and please give as generously as you can. Donations of any amount are greatly appreciated.

Thank you so much for what you’ve already done to make our work possible,

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We Want To Hear From You

By Jim Turner, Chair of Citizens for Health

Over the next two or three weeks, as Congress begins focusing its attention on several issues that affect natural health and organic food consumers, we at Citizens want to be careful of your time and resources.

We would like to hear from you about how frequently you want to hear from us. If you suffer from TMI (too much information) from us let us know. We’ll cut back on what we send you. In the mean time here are some issues you will be hearing about from us:

• The most sweeping reform of food safety in fifty years is about to hit the Senate floor. Unfortunately it is very likely to pass even though it lacks effective measures to address many serious concerns about food safety such as:

– feeding of slaughter house waste to animals

– the use of antibiotics and hormones in feed to promote animal growth

– the spread of GMO’s (genetically modified organisms in food)

– the presence of pesticide residue in food

– the failure to require labeling of food that use radiation, GMO’s antibiotics, hormones, and pesticide residue in their manufacture.

Each of these failings leaves a serious potential source of food born disease unaddressed. We will inform you as aspects of the food safety debate as this legislation moves through the Senate, the House Senate Conference and toward the President’s signature. Specifically we want to inform you of the efforts of some advocates who are proposing changes to the bill which we support. Here are two of them:

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Food Safety Bill’s Ban on BPA Resisted

By Lyndsey Layton, Washington Post Staff Writer

The food industry and major business groups, including the U.S. Chamber of Commerce, are threatening to withdraw support for a long-pending bill to improve food safety, saying they are upset by a proposed amendment that would ban bisphenol-A, a controversial chemical, from food and beverage containers.

The bill is the Senate version of legislation passed overwhelmingly by the House last year. It is designed to give the Food and Drug Administration vast new regulatory authority over food production and place greater responsibility on manufacturers and farmers to produce food free from contamination. It had broad bipartisan support and backing from the White House, and it was expected to come to the Senate floor before the Memorial Day recess.

But in a letter to Sens. Tom Harkin (D-Iowa) and Mike Enzi (R-Wyo.), the chairman and ranking minority member on the Senate Health, Education, Labor and Pension Committee, the business groups said last week that they oppose an amendment by Sen. Dianne Feinstein (D-Calif.) that would ban bisphenol-A, or BPA, from food and beverage containers.

“We will not support food safety legislation that bans or phases out BPA from any food and beverage container,” said Scott Faber, vice president for federal affairs for the Grocery Manufacturers Association, which represents food companies and retailers.

BPA is used in thousands of consumer goods, including compact discs, dental sealants, and credit card and ATM receipts, but health advocates say they are most concerned about BPA’s presence in plastic food containers, bottles and the epoxy linings of metal cans because it can leach into food and beverages. It is found in the urine of more than 90 percent of the U.S. population, according to federal estimates.

More than 200 studies have connected BPA to a range of health concerns, including cancer and developmental and reproductive problems. Some U.S. states and cities have banned its use in certain products, primarily in items for young children that come into contact with food. Many companies have voluntarily removed BPA from their products or required suppliers to provide BPA-free options.

The FDA said in January that it had “some concern” about possible health effects linked to BPA but did not have enough reason to restrict its use and would study the question over 18 to 24 months. The Environmental Protection Agency says that it, too, wants to study the matter. And the National Institutes of Health are spending $30 million over the next two years, also examining whether BPA poses a health risk.

“We trust the FDA to complete a safety assessment for BPA, and we don’t think the Senate should short-circuit and undermine the FDA,” Faber said.

But Janet Nudelman, director of program and policy at the Breast Cancer Fund, said: “There’s really no question that BPA is a food safety issue. The food safety bill is absolutely the right place to move this forward.”

Feinstein and Rep. Edward J. Markey (D-Mass.) introduced a bill last year to ban the chemical from baby bottles, sports water bottles, reusable food containers, infant formula liners and food can liners. Feinstein is using that as a model for an amendment to the food safety bill, her staff said.

“I feel very strongly that the government should protect people from harmful chemicals,” Feinstein said in a statement released by her office. “BPA should be addressed as a part of the food safety overhaul.”

BPA was developed in the 1930s, and commercial uses exploded in the 1950s after scientists discovered its ability to make plastics more durable and shatterproof. A ban would create significant problems for many food manufacturers who do not have BPA-free alternative packaging, Faber said.

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Proposed FDA Food Safety Bill Modified to Protect Natural Supplements

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According to information reported by the Alliance for Natural Health, a Congressional bill designed to overhaul food safety regulations has been modified to exempt food supplements from regulations included in the bill. The FDA Food Modernization Act (S. 510), which has been a source of concern for supplement sellers and consumers, had included language which implied that U.S. trading partners would have to “harmonize” with Codex Alimentarius. The Codex is an international set of regulations that would affect access to many supplements, as it establishes uniform regulations that would supersede national laws governing foods and supplements. Already, a number of European countries and Canada have enacted regulations that greatly restrict the sale and purchase of herbal and nutritional supplements. Supplements under these provisions are addressed more like pharmaceutical drugs, which require extensive time and enormous expense to get government approval.

Fears that S. 510 would limit access in America to natural supplements led health freedom advocates to lobby Senators such as Orrin Hatch (R) and Tom Harkin (D) to modify the legislation. The new language inserted in the bill states that “Nothing in this section shall be construed to affect the regulation of dietary supplements.” This language is not present in the already passed House of Representatives version of the FDA Food Modernization bill. The final draft of the bill may soon be voted on by the Senate, and although the current version appears to protect dietary supplements there is no guarantee that a final version which integrates the House and Senate versions of the bill would retain this protection.

The Senate bill S. 510 was initially sponsored by Senator Richard Durbin (D). Natural health advocates have been vocally concerned with this bill as well as a legislation introduced by Senator John McCain (R), which more directly challenged existing limits on the FDA’s regulations covering the natural supplement industry. Although the McCain bill appears to have been dropped from the current legislative agenda, there are concerns that the agenda of imposing tyrannical restrictions on supplements will be renewed or brought forward in more covert ways. Advocates of the new legislations claim that laws are needed to protect the public from product hazards. However, critics counter that sufficient safety regulations already exist and just need to be properly enforced.

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