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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.

Health Freedom Nation: Consumers Take Control

By James J. Gormley, The Gormley Files

Courtesy of NOW Foods

Consumers and the health-food industry may have stopped S. 3002 in its tracks, but S. 510 and other threats to health freedom remain. Nevertheless, a new slate of bills, along with a re-invigorated health-freedom movement, offer new hope for the future.

Since the health-food movement’s earliest origins in New Hampshire in the 1790s, there have been many champions of health freedom. The one who immediately springs to mind, at least for me, is Frank Murray, who happened to be my first boss before I became editor of Better Nutrition magazine in 1995.

In 2006, Frank was the recipient of the Natural Product Association (NPA) President’s Award for “long-time contributions to the natural products industry.”

He was for many years editor of Health Foods Retailing, the health-food industry’s very first trade publication and the official magazine of the NPA for 50 years, from the late-1930s until the mid-1980s.

More Than One Slingshot
A bestselling health-book author, Frank has been one of the industry’s most articulate, enthusiastic and tireless crusaders, having stood arm-in-arm with Milton Bass, Max Huberman and NPA in successful opposition to the Vitamin Volstead Act from 1966 through 1976, when the Proxmire Vitamin Bill was signed into law.

His book, More Than One Slingshot, which was written for the association, tells the history of the health food industry from its origins in the late 1890s up through the early 1980s.

The book has this great, dated cover that I love, one which depicts David and Goliath, a popular representation of the battle between the health-food industry and the U.S. Food and Drug Administration (FDA).

Today, in early 2010, we face many of the same threats to health freedom even if the names of the bills and the players have changed.

Today’s Threats to Health Freedom
In March of 2009, Sen. Richard Durbin (D-IL) introduced S. 510, the Food Safety Modernization Act, a bill that would hand over extensive, unwarranted powers to an agency, the FDA, that has shown that it cannot objectively and properly fulfill its mission regarding dietary supplements since it constantly works to undermine the Dietary Supplement Health and Education Act of 1994 (DSHEA) through coordinated suppression of supplement companies and health information regarding products sold by legitimate manufacturers.

As this bill was reviled by consumers and farmers across the country, it appeared to fall by the wayside, that is until Sen. John McCain introduced S. 3002, the Dietary Supplement Safety Act of 2010.

Senate Bill 3002 was said to be about athletics ? trying to protect athletes from spiked or doped supplements (although one would think the athletes would know what they were taking, especially if they themselves ordered these products from shifty chemists and fly-by-night pharmacists), but it included a whole host of anti-supplement provisions that almost made S. 510 pale by comparison.

A firestorm of consumer outrage ensued: many tens of thousands of letters were sent to the Senate thanks to powerful grassroots advocacy campaigns organized by Citizens for Health, the Alliance for Natural Health and the NPA. In early March, Sen. McCain decided to withdraw his support of the bill, with the caveat that certain provisions should be carried over to S. 510, most of which are already in S. 510 as it now stands.

Consumers, and the natural products industry, must be especially vigilant now and throughout 2010 ? regarding S. 510 so that the bad provisions in this bill are dropped or drastically revised, and that nothing even worse from the dry-docked S. 3002 winds up being added to S. 510.

Tomorrow’s Health Freedom Opportunities
As to bills that offer a ray of hope, there are currently three main ones: H.R. 4913, H.R. 3394 and H.R. 3395.

On March 23rd, Rep. Jason Chaffetz (R-Utah) and Rep. Jared Polis (D-CO) introduced the Free Speech about Science Act (H.R. 4913); since then, Rep. Dan Burton (R-Indiana) has signed on as a co-sponsor. The bill allows producers of healthy foods and dietary supplements to cite legitimate scientific studies on the health benefits of their products.

Rest of article can be read here

Update: Sen. McCain Response Letter To Sen. Hatch About S. 3002

Parts of the McCain Dorgan bill (S. 3002) are now being added to the Food Safety Bill (S.510), rather than trying to pass on its own. This letter presents four points which leave in tack several of the objections to the original McCain Dorgan bill that must be opposed. Citizens is opposing these additions to the Food Safety bill until the precise language is developed and can be evaluated. Citizens also opposes the Food Safety Bill as currently drafted because it endangers significant food safety advances of the past thirty years such as organic, locally grown, honestly labeled food; perpetuates the regulatory policies that have led to an unsafe industrial food supply; and offers no new approaches to creating real food safety. In short, the Food Safety bill, like the Health Reform bill, is a patch work of government mandates and directives that fail to achieve their announced purposes while perpetuating the very problems their supporters claim to address.

Hatch Letter

We Need Your Help

Dear Friend,

Today, you have the right to choose which vitamins, herbs, and supplements are best for you and your family. But your freedom to choose these products and your access to alternative and complementary treatment is under attack in Congress. Please donate to Citizens for Health today so that we can protect your rights and keep you informed.

Citizens for Health has a successful track record empowering consumers and defending your rights in law and policy. In 1994, we helped educate consumers and coordinate over 2.5 million letters to Congress supporting The Dietary Supplement Health and Education Act (DSHEA). Consumers won that hard-fought battle thanks to millions of people like you, who believe in their right to obtain and take dietary supplements.

We need your help again. Two weeks ago, Senators McCain and Dorgan introduced a bill called “The Dietary Supplement Safety Act ” which, if passed, will repeal key sections of DSHEA. Among other things it would give the FDA full discretion and power to compile a discreet list of supplements allowed to remain on the market while banning all others. You can learn more and sign our action request at http://www.citizens.org/?page_id=1868

Your donation today will help us educate and activate millions of people and protect your rights. We are posting frequent updates about the McCain and Food Safety bills at www.citizens.org, and will keep you informed.

The McCain bill, along with The Food Safety Bill (S. 510), represent a systematic attack on individual rights that directly impact how and what we choose to eat, prevent & treat disease and, promote our individual and family’s well-being. Indeed, in FDA hands, the authority created by these bills is likely to make both food and supplements less safe, less effective and much more costly.

Please donate online today at: www.citizens.org/?page_id=1779

Thank you for your support and solidarity!

Jim Turner

McCain Defends Supplements Reform Bill

By Shane Starling via www.nutraingredients-usa.com

Republican Senator John McCain of Arizona has issued a statement criticizing “lobbyists” of falsely attacking the Dietary Supplement Safety Act of 2010 he introduced at the beginning of the month, which seeks to amend DSHEA in several fundamental ways.

In the statement, McCain said: “Opponents have stated that the legislation would seek to limit consumers’ ability to purchase dietary supplements, vitamins, or prescription drugs. That is completely false…. If you take a vitamin now, this bill will in no way restrict your ability to take that vitamin.”

Senator McCain’s Bill requires companies to report non-serious adverse events to the Food and Drug Administration (FDA); gives immediate recall rights over products suspected of contamination; creates an Accepted Dietary Ingredients list in place of New Dietary Ingredients provisions and demands all facilities to register on a list annually.

It has drawn heavy criticism from industry which criticized it for being unnecessary, reactionary, regressive and potentially destructive of a healthy industry and the Dietary Supplement Health and Education Act (DSHEA) that governs it.

Senator McCain however said his Bill had been miscast and stated: “Opponents also claim the bill establishes a new regulatory structure for dietary supplements. That is completely false.”

Responding, the Alliance for Natural Health-US (ANH-US) said: “The broad regulatory framework for supplements at the moment is provided by DSHEA. McCain’s bill guts the protections provided by DSHEA and gives the FDA complete and arbitrary authority. If that isn’t a new regulatory structure, what is?”

The ANH-US pointed to Association of Poison Control Centers statistics that showed there were no dietary supplements-related deaths in 2008, the last year on record, despite claims from McCain that, “people have died from taking dietary supplements… and thousands have had to be hospitalized…”.

The bill can be found here.

Robust enforcement needed

Criticism of the Bill included that from founder and executive director of the American Botanical Council, Mark Blumenthal, who stated:

“It is understandable why legislators and others might feel the need to hold hearings and propose additional legislation to attempt to prevent or correct some of the problems in the dietary supplement industry.This includes the need to address problems of poor quality, intentional adulteration, exaggerated and unsubstantiated claims, and other excesses that exist in some pockets of the industry.”

He said the fact DSHEA had not in 15 years been, “adequately, uniformly, fully, and robustly enforced” fuelled the creation of such a Bill, but observed, “what is really needed is robust enforcement of existing laws and regulations, not more laws.”

A host of major sporting bodies including the National Football League (NFL) and Major League Baseball (MLB) have thrown their weight behind the Bill after Senator McCain said one of the motivations for introducing it was to combat contamination of sports supplements.

US Anti-Doping Agency chief executive officer Travis T Tygart stated: “The McCain bill is a fair and balanced approach that provides significant protections for all consumers of dietary supplements, while at the same time avoids placing unreasonable burdens on legitimate companies in the industry. We are grateful to Senator McCain for his strong leadership on this public health issue and urge other members of Congress to support this bill.”

Alternative Remedies At Risk

Via www.examiner.com

Alternative remedies such as natural health supplements using vitamins and herbs, natural herbal remedies and holistic treatment are at risk. Coast-to-Coast just released a taped interview about the bill yesterday. Senator John McCain proposed The Dietary Supplement Safety Act (DSSA ), February 4, 2010, to put the Federal Drug Administration (FDA) in charge of regulating natural health supplements.

Alternative remedies bill

Alternative remedies are protected because they are classified as food. However, the new bill reduces potency a product with 1/2 carrot’s worth beta carotene for example and provides a list of acceptable ingredients.

FDA in charge?

This is the same FDA that allows dangerous prescription drugs on the market with long lists of side-effects. Watch any commercial on television that has 15 seconds on therapeutic effects of the drug and 45 seconds on side-effects including 4 hour erection and “sudden death.” Charles Krauthammer, Washington Post.

New natural health supplements at risk

The new bill even requires minor adverse effects from natural health supplements to be reported which is believed opens the door of harassment and allowing the FDA to pull products from shelves they deem appropriate. “A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless there is a history of use or other evidence of safety.”

This wording means new ingredients can be squashed. The difference between regulation of drugs and natural health supplements is astounding. What is suggested is drugs are safe and food is not. If alternative remedies are to be protected, many feel this bill needs to be stopped.

Protect alternative remedies by contacting legislators

To do so, contact your representatives and ask they do not vote for the Dietary Supplement Safety Act (S. 3002). Then contact your friends and ask them to do the same. The John Birch Society offers a very easy-to-use form to do both.

If complementary and alternative medicine is to remain viable and to continue to buy vitamins, then legislators need to know about this bill. Vitamins and herbs, nutrition products and natural health supplements are at risk for continued use as alternative remedies.

Citizens for Health Advocate of the Month

Citizens for Health Advocate Natalie Hajdu recently attended a town hall meeting with John McCain.

Here’s what she had to say:

“Senator John McCain was campaigning in Payson so I opted to find out more information on this bill and what it would do to the lives of people who depend on supplements and our company. Senator McCain said he would protect his constituents who this bill would affect, such as myself. My hope is that he follows through.”

Please turn up your volume on your computer to listen to Natalie’s question and McCain’s response.

Senator Mikulski Response Letter To A Citizens.org Reader

The following letter was sent by Senator Mikulski of Maryland to one of our readers. We thought you’d like to see her perspective. Maybe all you folks in Maryland could apply some more pressure?

——————————————————————————————————-

Dear Ms. O’Leary:

Thank you for getting in touch with me about the use of dietary supplements. It’s good to hear from you.

I understand your concerns about the Dietary Supplement Safety Act of 2010 (S. 3002). This legislation would expand the Food and Drug Administration’s (FDA) oversight of dietary supplements by giving the FDA the power to conduct thorough testing of any dietary supplement to ensure its safety before the product reached the market. The FDA also would be able to recall any supplements that are found to be unsafe. S. 3002 is currently pending in the Senate Committee on Health, Education, Labor and Pensions. I am a member of this committee and will keep your concerns in mind as we continue to consider this legislation.

I know that many people rely on dietary supplements to enhance their health. I believe we have already done a great deal in Congress to enhance FDA oversight. In the past, I supported the Dietary Supplement Health and Education Act because I saw the need for better regulation of the use and marketing of these supplements. That measure, which is now law, holds manufacturers responsible for ensuring that their supplements are safe before they reach the market. I also supported the Food and Drug Administration Modernization Act, which prohibits manufacturers from making unsubstantiated health claims about their products. It is vital that we strike a balance between the need to protect consumers from fraudulent products and the need to ensure access to dietary supplements.

Thanks once again for writing. Please let me know if I can be of assistance in the future.

Sincerely,

Barbara A. Mikulski

United States Senator

Anti-Supplement “Perfect” Storm Building in Washington

By James J. Gormley, VP and Sr. Policy Advisor, Citizens for Health
Via The Gormley Files

As if Senate Bill 3002 (S. 3002) were not more than enough to deal with, according to The Hill Rep. John Dingell (D-Mich.) is criticizing the Senate for not moving on Senate Bill 510 (S. 510).

Unfortunately, The Pew Charitable Trusts has been assisting with a coordinated lobbying effort to press Senate leaders to bring the bill to the floor. Sandra Eskin, director of Pew’s food safety campaign, told The Hill that she is “cautiously optimistic” that a vote can occur in the first half of March, before the Senate’s next recess week starts on March 29.

Regan LaChapelle, a spokeswoman for Sen. Harry Reid (D-Nev.), told The Hill that the majority leader hopes to bring the bill to the floor either during the current work period or the next, which runs from April 12 to May 28. “It’s on our list of legislative priorities,” she said. “It could be in March or the next work period. Obviously we have many issues to address.”

House Republicans were split on H.R. 2749, with 54 supporting it and 122 opposed. GOP members who backed it include Reps. Michele Bachmann (Minn.), Joe Barton (Texas), Dave Camp (Mich.) and Greg Walden (Ore.).

After the House bill passed, Rep. Frank Lucas (R-Okla.) told The Washington Post: “The federal government will tell our farmers and ranchers how to do something they’ve been doing since the dawn of mankind. It goes too far in the direction of trying to produce food from a bureaucrat’s chair in Washington, D.C.” Twenty House Democrats opposed the bill.

Now moreso than in recent memory, it is critical that we all stay tuned to these issues, keeping an eye out for our continuing posts and opportunities for action on S. 3002 and S. 510 — and whatever else floats down the Potomac that threatens DSHEA, our supplements and our health-food stores!