Life Extension Magazine May 2014
Alliance for Natural Health Protecting Your Supplements against Government Censure
By Craig R. Smith
If he had his way, one senator would remove most of your nutritional supplements from the market. But Life Extension® and the Alliance for Natural Health USA (ANH-USA) are working hard to stop him.
ANH-USA is part of an international organization dedicated to promoting sustainable freedom of choice in healthcare through good science and good law. Since 1992, they have worked to shift the medical paradigm from an exclusive focus on surgery, drugs, and other conventional techniques to an integrative approach incorporating functional foods, a healthy diet, dietary supplements, and lifestyle changes. To ensure consumers’ rights, ANH-USA lobbies Congress and state legislatures, acts as a government watchdog, files comments on proposed rule-makings, and educates the public, the press, and other decision-makers.
Richard “Dick” Durbin, the senior US senator from Illinois and the Senate Majority Whip since 2007, recently said on National Public Radio1 that all he wants is for supplements to be safe and effective. No one would disagree with that. But behind the soothing and frankly deceptive words, he actually wants to treat supplements like drugs.
Drug companies may spend up to an average $5.8 billion per drug to win FDA approval.2 Drug companies can pay these enormous sums because their products are synthetic and therefore patentable. Once patented and approved, a drug becomes a monopoly and can be sold at any price, even for hundreds of thousands of dollars per patient.
As readers of Life Extension® magazine are well aware, food and supplements are typically safer than drugs and may even be more effective in keeping you healthy. In part this is because they are natural and therefore not patentable. The bottom line is clear to Durbin: require that billions be spent on each supplement for approval, and presto, no more supplements. The best thing about this stealthy approach is that not even the average legislator, much less the public, would understand that supplements could be at risk for extinction as we now know them.
Each year there are over 487 times more adverse event reports for FDA-approved prescription drugs than there are for supplements, and 446 times more serious events for drugs than supplements.3 Yet, Durbin thinks that supplements are endangering the public? The adjacent graph makes the difference obvious.
A Deceptive Bill
In 2011, the senator introduced a bill he called the Dietary Supplement Labeling Act. He said his bill was designed to stop “mislabeling products and making health claims that have no scientific basis” and “marketing supplements with impure or incorrectly identified ingredients.”4 He knows—or should know—that all those things are already against the law!
Since the purpose of this bill was clearly not the one stated, what was its purpose? It seems that this was an attempt to move us one step closer to a full FDA approval system for supplements. That, of course, would make supplements insanely expensive, like drugs, if you could get them at all. If supplements are not yanked from the market—as they could be if the FDA doesn’t “approve” them—or turned into drugs, the high prices would kill demand and drive supplement companies out of business. The drug industry would be waiting, ready to pick up the pieces and make their current monopoly position even tighter.
Durbin’s bill required that the FDA, together with the government’s Institute of Medicine (IOM), compile a list of dietary ingredients (read: supplements) that could possibly lead to adverse events or are otherwise deemed risky in some way. Dietary supplement manufacturers would have to put mandatory warnings on labels for any ingredient on this list.
What the FDA and the IOM have in common is that both agencies know very little about supplements but are nevertheless deeply biased against them.
In the FDA’s case, this may be because of all the fees that the agency gets from drug companies.5 Or because many of the agency’s outside panelists are paid by drug companies.6 Yet these are the people whom Senator Durbin wants to give complete arbitrary power over supplements!
As for the Institute of Medicine (IOM), look at their recent report on vitamin D.7 They threw out most of the scientific research.7 The IOM is hardly the authority to determine which supplement is safe and which isn’t!
Creating lists of “bad” ingredients or “bad” doses based on completely arbitrary or non-existent standards is a slippery slope. It could be used as a hammer by the FDA to go after supplement companies. It could easily lead to European-style standards being applied here in the US. In Europe, if a beta carotene capsule contains more beta carotene than is in around one-third of a large carrot, it is banned.8
Current law already requires that all dietary supplement products show ingredient lists. Health claims already have to be pre-approved by the FDA according to the Nutrition Labeling and Education Act.9 Supplements must be manufactured under Current Good Manufacturing Practices to ensure that the ingredients are safe and at the levels they claim them to be.10 Accurate disclosure of the contents in the dietary supplement package is required under the Fair Packaging and Labeling Act. And almost all supplement manufacturers have a list of all their products and ingredients available to the public on their websites. In other words, everything the bill mandates is already being accomplished under laws now on the books!
Durbin Meets His Match
That’s where Alliance for Natural Health (ANH-USA) enters the picture. The moment the Durbin bill was introduced, ANH-USA sent Action Alerts to its members and to the hundreds of thousands of readers of the Pulse of Natural Health, its weekly newsletter. It also contacted important allies such as Life Extension® to be sure that an even larger number of messages were sent.
While consumers contacted their senators calling for the defeat of this bill, ANH-USA kept up the pressure through lobbying on Capitol Hill. In the end, the pressure was so great that the bill became a hot-potato, and no one would touch it. The bill died in committee.11
That same year, Durbin decided to try a different approach to get the same results. He proposed an amendment to an appropriations (budget) bill, 12 which is a sneaky way of getting controversial laws passed without too much attention. The amendment wanted the FDA to follow the recommendations of a report containing some of the same provisions that were in Durbin’s anti-supplement bill! Happily, because of the pressure ANH-USA and its allies were able to bring to bear, Durbin’s sneaky amendment didn’t make it into the appropriations bill.
One month later, however, Sen. Durbin and his frequent collaborator in the House, Rep. Henry Waxman (D-CA) were back at it. They asked the Government Accountability Office (GAO) to review adverse event report data13—but only for supplements. If consumer safety was really Sen. Durbin’s motivation, why didn’t he and Rep. Waxman also ask the GAO to review adverse event reporting data for vaccines and drugs, which have far more reported adverse events?
Fast forward to May of 2012. The FDA Safety and Innovation Act was considered “must-pass” legislation, and without notice, Senators Durbin and Blumenthal offered a new anti-supplement amendment14 to the bill. Once again, ANH-USA issued an emergency Action Alert, and readers sprang into action, sending more than 100,000 messages in less than twenty-four hours. Congress listened, and Sen. Durbin’s anti-supplement amendment was soundly defeated by a vote of 77 to 20.14
In March of 2013, the GAO report on adverse event reports15 requested by Sen. Durbin and Rep. Waxman was finally issued. It left both legislators with egg on their face. The report they hoped would say supplements are dangerous only proved how incredibly safe supplements are—and says, “…the greatest challenge for identifying potential safety concerns from AERs [adverse event reports] is the small number of AERs [adverse event reports] that FDA receives related to dietary supplements.”15
You’d think that would be the end of it, but you’d be wrong. Shockingly, in August of 2013, Sen. Durbin reintroduced his misleading anti-supplement bill 16—the one he couldn’t garner enough support for in 2011. Its language is identical to that of his previous bill, and would deal the same deadly blow to nutritional supplements. ANH-USA and its allies are battling on Capitol Hill once again.
Two Powerhouses, Working Together
ANH-USA celebrated its twentieth anniversary last year. It has over 250,000 members nationwide—and it is only because of them that the organization is able to be so successful.
Thanks to its members and allies like Life Extension, ANH-USA is changing the politics of medicine. Most critically, ANH-USA has played an important role in passing significant legislation that directly benefits the natural health approach while blocking legislation that threatens it.
ANH has also filed lawsuits to accomplish the same aims. To date, they have filed nine precedent-setting lawsuits against the FDA, which have established qualified health claims for saw palmetto, omega-3 fatty acids, fiber, vitamin E, vitamin B, and selenium. One of their early suits was the landmark case of Pearson v. Shalala—and because they won, there is now widespread public knowledge about the importance of consuming enough folate (a B vitamin) during pregnancy to prevent neural tube defects.17 Prior to this legal victory, supplement manufacturers were not permitted to let consumers know about this important nutrient relationship, and many consumers were in the dark.
Life Extension is one of ANH-USA’s most important allies. With the support of grassroots activists and organizations like Life Extension, ANH-USA has had a number of major victories for consumers.
- Incorporated an explicit statement into HIPAA that the practice of alternative medicine is not fraud—a critical protection for alternative healthcare practitioners.
- Led the effort to establish the National Center for Complementary and Alternative Medicine in 1998. It’s part of NIH, undertakes research, does training, and disseminates data to the public and professionals.
- Worked with Reps. Chaffetz and Polis to introduce the Free Speech about Science Act, which will permit food and supplement companies to cite peer-reviewed scientific research in support of a product’s health benefits. It is hard to believe, but all too true, that free speech protections do not extend to food or supplement companies to make truthful statements about scientific research.
- Organized an emergency response to a major threat to dietary supplements in Congress: Sen. McCain’s Dietary Supplement Safety Act. ANH-USA members sent more than 200,000 messages to Congress opposing the bill, and the organization took out a full-page ad in Roll Call, the Capitol Hill newspaper, which highlighted misleading remarks from Sen. McCain on the Senate floor. In just three weeks, Sen. McCain took the almost unheard-of step of withdrawing support for his own bill, which subsequently died without a vote.18
- Defeated a sneak amendment to the Wall Street Finance Reform bill from Rep. Waxman that would have greatly expanded the Federal Trade Commission’s power to restrict supplements.
- Sent messages to Congress opposing Sen. Leahy’s Food Safety Accountability Act, which would have established ten-year prison terms for violating FDA regulations. This resulted in Leahy’s office reaching out to ANH-USA to develop compromised language requiring proof of actual harm for prosecution.
- Filed petitions to ban the use of the toxic chemical BPA in cash register receipts and children’s dental devices.
- Petitioned the USDA and FDA to study GMOs, and supported state bills to demand GMO labeling. These petitions are a necessary prelude to lawsuits.
- Organized a coalition of dietitians and nutritionists to oppose the American Dietetic Association’s ties to junk food companies and anti-competitive legislation, and launched ReallyEatRight.org to bring to light the ADA’s attempts to establish a monopoly on nutritional advice through state and national legislation.
- Openly opposed draft guidance on New Dietary Ingredients (NDI) that threatened to remove 29,000 dietary supplements from the market—and became the only consumer organization invited to the FDA’s bargaining table.
- Helped amend the Drug Quality and Security Act of 2013 which would have given the FDA power to regulate large compounding facilities. ANH-USA worked with Congress—across party lines—to protect important ingredients such as compounded bioidentical estriol and time-released medications, and make sure non-standardized dosages remain available to be tailored to the individual.
ANH-USA monitors legislation and regulatory activity on the state, federal, and international levels daily. This is in addition to court action, since the court system has a critical role in protecting integrative medicine and a consumer’s right to choose.
The organization’s executive and legal director is Gretchen DuBeau. A lifelong environmentalist and devotee to closely related natural health and healing, Gretchen is an attorney who practiced environmental law and policy for five years before joining ANH to work on natural and sustainable health issues. She is joined by Liz Ardagna, membership director; Nandini Gopinadh, legislative and policy analyst; and Beth McCabe, director of public affairs. ANH’s International and European office is led by Dr. Robert Verkerk, a widely acclaimed expert in agricultural, environmental, and health sustainability.
In the year ahead, ANH-USA will continue to fight for consumers’ rights to free access to healthy food and nutritional supplements—as well as the right to information about them. ANH-USA currently keeps close tabs on Sen. Durbin’s Dietary Supplement Labeling Act of 2013,16 the zombie bill that refuses to stay dead. If this bill passes, supplements would either be pulled from the market, or would see their prices rise so high that no one could afford them. Countless supplement companies would be driven out of business.
This need not happen. ANH-USA is asking Life Extension magazine® readers to take action on it! By going to ANH-USA.org/LEF, you’ll be taken to a page with more information and a form that will let you effortlessly send a message to your senators, asking them to oppose Sen. Durbin’s bill.
And while you’re at it, you can also subscribe to ANH-USA’s weekly e-newsletter, The Pulse of Natural Health, on the front page of the organization’s website at ANH-USA.org. There you can keep abreast of the latest politics affecting your ability to make health choices.
One last thing: an incredibly generous donor has offered to match all donations to ANH-USA from Life Extension readers—up to $100,000. What that means is that if Life Extension readers collectively donate $50,000 to AHN-USA, this donor will contribute another $50,000—up to $100,000.
Just go to ANH-USA.org/LEF and you’ll be able to support ANH-USA’s important work in protecting your supplements painlessly—and powerfully. Donations of any amount are greatly appreciated, no matter how small.
If you have any questions on the scientific content of this article, please call a Life Extension® Health Advisor at 1-866-864-3027.
- Available at: http://www.npr.org/2013/11/08/243950746/navigating-dietary-supplement-regulations. Accessed February 12, 2014.
- Available at: http://www.manhattan-institute.org/html/fda_05.htm. Accessed February 14, 2014.
- Available at: http://www.crnusa.org/CRNPR10_CRNquestionsaccuracyofherbalstudy020110.html. Accessed February 14, 2014.
- Available at: http://www.washingtontimes.com/news/2011/aug/9/mislabeling-supplements-does-a-disservice/. Accessed February 14, 2014.
- Available at: http://www.fda.gov/ForIndustry/UserFees/. Accessed February 14, 2014.
- Available at: http://www.cbsnews.com/news/reports-emails-show-alleged-pay-to-play-between-drug-companies-fda/. Accessed February 14, 2014.
- Available at: http://www.anh-usa.org/institute-of-medicine-report-on-vitamin-d-is-wrong-wrong-wrong/. Accessed February 14, 2014.
- Available at: http://anh-europe.org/campaigns/freedom-health-choice. Accessed February 14, 2014.
- Available at: http://www.health.gov/dietsupp/execsum.htm. Accessed February 14, 2014.
- Available at: http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm. Accessed February 14, 2014.
- Available at: http://www.naturalproductsinsider.com/news/2012/05/durbin-s-anti-supplement-amendment-defeated.aspx. Accessed February 14, 2014.
- Available at: http://thomas.loc.gov/cgi-bin/bdquery/z?d112:SN01310:@@@L&summ2=m&m. Accessed February 14, 2014.
- Available at: http://www.hpm.com/pdf/blog/DurbinWaxmanGAODSLtr.pdf. Accessed February 14, 2014.
- Available at: http://capitolwords.org/date/2012/05/24/S3536-2_food-and-drug-administration-safety-and-innovation/. Accessed February 14, 2014.
- Available at: http://www.gao.gov/assets/660/653113.pdf. Accessed February 14, 2014.
- Available at: http://thomas.loc.gov/cgi-bin/query/z?c113:S.1425.IS:/. Accessed February 14, 2014.
Available at: http://scholar.google.com/scholar_case?case=4761224701982503702. Accessed February 14, 2014.
- Available at: http://www.anh-usa.org/wp-content/uploads/2010/03/Senator-Hatchs-Letter-to-Senator-McCain1.pdf. Accessed February 14, 2014.
- Available at: https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page= UserAction&id=1627. Accessed February 14, 2014.