Category : DSHEA Under Fire

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Brief Description of the Provisions of the Dietary Supplement Safety Act of 2010

New Requirements from Suppliers to Retailers

Suppliers and retailers regardless of size all along the chain of commerce are required to “obtain adequate written evidence” from the seller that the product is registered as required. That evidence must be retained in a file available for inspection.

Adverse Event Reporting (AER)

Requires reporting of all adverse events, not just serious adverse events. In addition, a compilation of non-serious AERs must be submitted annually, and records must be maintained for three years.

“Accepted Dietary Ingredients” List

Mandates creation by the Secretary of a list of “Accepted Dietary Ingredients” to replace the current “in commerce pre-DSHEA” test.

New Dietary Ingredients (NDI)

NDIs are considered adulterated unless there is a history of use or evidence of its safety. Registrants shall maintain a “scientifically reasonable substantiation file” available for inspection by the Secretary of Health and Human Services. Registration required 75 days prior to market.

Recall Authority

Provides immediate recall authority to the Secretary upon determination that a supplement “would cause serious, adverse health consequences or death, or is adulterated or misbranded.” Companies subject to a recall have the right to challenge the order in an “informal hearing” within 10 days. At their own expense, retailers must notify customers of such recalls.

Registration of Dietary Supplement Facilities

Dietary supplement facilities shall register with the Secretary (required information includes name, address of all facilities, trade names, list of supplements, their ingredients, and labels). Registration is annual.

The DEA Should Take Over All Sports Doping Enforcement

By James J. Gormley
original link: The Gormley Files

In February 2010 in New Orleans, three men were charged by the U.S. Drug Enforcement Administration (DEA) with drug-trafficking Ecstasy, or MDMA (3-4-Methylenedioxymethamphetamine), a synthetic chemical that can be derived from an essential oil of the sassafras tree.

If convicted, the defendants face a possible maximum sentence of 20 years in prison, a $1 million fine and at least three years of supervised release for each count.

MDMA is also one of the easiest illegal drugs to obtain. Its effects are similar to those of amphetamines and hallucinogens. First developed as an appetite suppressant in 1912, MDMA was used as a psychotherapeutic tool and also started to become available on the street is the late 1970s and early 1980s. It wasn’t until 1985 that Ecstasy was made illegal. It is classified as a “Schedule 1” controlled substance along with other narcotics like heroin, cocaine and LSD.

One reason Ecstasy can be especially dangerous is the lack of content control. Ingredients are hard to get and manufacturers of the drug often use substitutes, mixing other harmful additives with the already dangerous mix. This practice is so common that “drug test kits” are often sold with the drug so users can test for purity.Because of the uncertainties about the drug sources, pharmacological agents, chemicals used to manufacture them, and possible contaminants, it is difficult to measure the toxicity, consequences and symptoms that might be expected.

Herbal Ecstasy is another form of MDMA that is composed of ephedrine (ma huang) or pseudoephedrine and caffeine from the kola nut. Also sold in tablet form, Herbal Ecstasy can cause permanent brain damage and death. Though not currently classified as a controlled substance, Herbal Ecstasy shares many of the same qualities and effects as MDMA. Also known as Cloud 9, Herbal Bliss, Ritual Spirit, Herbal X, GWM, Rave Energy, Ultimate Xphoria and X.

Anabolic Steroids

Anabolic steroids are synthetically produced versions of the naturally occurring male hormone, testosterone. Both males and females have testosterone produced in their bodies: males in the testes, and females in the ovaries and other tissues. The full name for this class of drugs is androgenic (promoting masculine characteristics) anabolic (tissue building) steroids (the class of drugs).

Some of the common street names for anabolic steroids include: arnolds, gym candy, pumpers, ‘roids, stackers, weight trainers and juice. Currently, there are more than 100 different types of anabolic steroids that have been developed, and each requires a prescription to be used legally in the U.S.

Anabolic steroids can be taken orally, injected intramuscularly, or rubbed on the skin when in the form of gels or creams. These drugs are often used in patterns called cycling, which involves taking multiple doses of steroids over a specific period of time, stopping for a period, and starting again. Users also frequently combine several different types of steroids in a process known as stacking. By doing this, users, more properly abusers, believe that the different steroids will interact to produce an effect on muscle size that is greater than the effects of using each drug individually.

Another mode of steroid use is called “pyramiding.” With this method abusers slowly escalate steroid use (increasing the number of drugs used at one time and/or the dose and frequency of one or more steroids), reach a peak amount at mid-cycle and gradually taper the dose toward the end of the cycle. The escalation of steroid abuse can vary with different types of training. Bodybuilders and weight lifters tend to escalate their dose to a much higher level than do long distance runners or swimmers.

Senator McCain Files New Bill That Attacks Your Access to Supplements and Repeals Key Sections of the Dietary Supplement Health and Education Act

original link: The Delano Report

McCain’s bill is called The Dietary Supplement Safety Act (DSSA). It would repeal key sections of the Dietary Supplement Health and Education Act (DSHEA). DSHEA protects supplements if 1) they are food products that have been in the food supply and not chemically altered or 2) if they were sold as supplements prior to 1994, the year that DSHEA was passed. If a supplement fits one of these two descriptions, the Food and Drug Administration (FDA) cannot arbitrarily ban it or reclassify it as a drug.

These protections are far from perfect. They discourage companies from developing new forms of supplements. New supplements may be arbitrarily banned by the FDA or adopted by drug companies in a way that precludes their further sale as supplements.

McCain’s bill would wipe out even the minimal protections contained in DSHEA. 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.

Everyone knows that the FDA is friendly to drug companies (which pay its bills and provide good revolving door jobs) and hostile to supplement companies. Under this bill, this same Agency could quite arbitrarily ban any supplement it wished or turn it over to drug companies to be developed as a drug and sold for multiples of its price as a supplement.

We must prevent this bill from gaining traction! Protect your access to supplements by contacting your senators today and asking them NOT to co-sponsor the Dietary Supplement Safety Act but rather to oppose it.

McCain’s Dietary Supplement Safety Act (DSSA) appears to be supported by the US Anti-Doping Agency (USADA) which is funded by major league sports teams including baseball, football and others. The recent suspensions of NFL and other professional sports figures is much in the news, and the goal of the sports industry appears to be to shift the spotlight from their players to the supplements industry. In his comments, Senator McCain cited six NFL players recently suspended for testing positive for banned substances and purportedly exposed to these substances through dietary supplements.

The problem here of course is one of illegal sale and use of steroids. So why dismantle the supplement industry in order to control already illegal substances?

The FDA currently has complete and total authority to stop illegal steroids and, more broadly, to regulate dietary supplements. If the agency were doing its job, it could and would have prevented the sale of illegal steroids. The answer to this problem is not to give FDA more power. The Agency simply needs to do it’s job.

Why would a bill be offered to solve an illegal steroid problem that does not really address the steroid problem but instead gives the FDA complete and arbitrary control over all supplements? The answer is simple.

There are a lot of vested interests which are threatened by supplements. Drug companies do not like them because they represent a low cost, safer, and often more effective alternative to drugs. The FDA does not like them because supplements do not come through the FDA approval process and therefore do not support the FDA budget.

A Medical Doctor’s Open Letter Opposing the McCain Sponsored Dietary Supplement Safety Act (DSSA)

Dear Senator McCain:

Though I am a resident of New York, not Arizona, I suggest that someone in your staff reads my letter very carefully as I believe you are unwittingly sponsoring a bill with potentially onerous consequences, one that might if I read the information about it properly, lead to the death of hundreds of my patients fighting advanced, terminal cancer. I do not think, if I am correct in my interpretation, that you would want their death on your conscience.

As some background, I am a registered Republican, and in the past have donated many thousands to Republican causes including your re-election, even when it became clear to me the Party, including you, had strayed significantly from its mission of limited government, deficit reduction, and ultimately, protection of individual liberty. In terms of my professional activities, I am a former journalist (Time Inc), currently a physician and cancer researcher, who educated at three Ivy League schools (Brown undergraduate, Columbia post grad, Cornell for medical school). I finished a fellowship in cancer immunology under Robert A. Good, for ten years President of Sloan-Kettering, and the most published author in the history of medicine. Under Dr. Good’s direction, 29 years ago I began researching the use of diet, nutrients, and proteolytic enzymes against advanced cancer.

I am a serious scientist working seven days a week trying to help those for whom there is no other help. Though some consider my work “alternative” and though in the past my treatment has generated controversy since my therapy does not conform to the drug company model, I have been funded by very mainstream corporations and institutions including Procter & Gamble, Nestle, and the NIH. Congressman Dan Burton (R, Indiana) has long been a vocal supporter, and I have met with Senator Harkin at his invitation to discuss this treatment. My research has been featured in a lengthy profile appearing in the New Yorker Magazine (Feb 5, 2001) and more recently in the major best-selling book Knockout about innovative new approaches to cancer, written by the actress and writer Suzanne Somers. I appear regularly in the media, which increasingly has taken a very positive view of my work. In addition, my colleague Dr. Linda Isaacs and I recently published our first book in a projected series, The Trophoblast and the Origins of Cancer, that discusses in some detail the scientific support for our treatment approach. You can learn more about my background and therapy at our website: www.dr-gonzalez.com

In our New York practice, we are currently treating hundreds of patients diagnosed with terrible advanced cancer for whom no conventional options exist. Many are successfully battling their disease with our regimen of diet, nutritional supplements, and proteolytic enzymes—which are currently available legally as over-the-counter items. We use only high quality products, manufactured by my stringent specifications.

Though I suspect you and your staff created this new bill with the good intention of protecting the public, as I read information about the bill, it appears to give the FDA near-dictatorial control over the manufacture and availability of supplements, allow them at their own arbitrary discretion to remove legitimate nutritional supplements from the marketplace, file complaints against particular legitimate supplements at their whim, and impose drug testing standards on each supplement. Testing of a single product to meet FDA standards for marketing of a new drug alone can cost hundreds of millions of dollars. No supplement company to my knowledge has the resources to fight or meet such regulatory impositions. As an end result, ethical supplement companies as they currently exist would, again if I read the bill correctly, be forced to shut down.

I have read that you are motivated by recent scandals involving the doping of athletes with illegal steroids, certainly a terrible tragedy, and have been approached by various professional athletic organizations such as Major League Baseball. I believe these organizations are trying to shift blame from their athletes to the supplement industry. Regardless, the FDA already possesses power to investigate and punish companies marketing and selling steroids improperly—the issue at stake here—and requires no additional authority to do so. It certainly does not now need added control over properly manufactured and properly marketed supplements or food substances and the companies that provide these products, in order to regulate illicit steroid spiking.

I suppose, on the surface, the bill sounds innocent enough, requiring manufacturers to provide the FDA with ingredients, etc. But current Good Manufacturing regulations to my understanding already require that supplement companies must provide proof of ingredients and quality. This proposed bill, whatever your stated goal, appears to play into the FDA’s long standing animus against the supplement industry at large, which to date has some protection from capricious regulatory harassment under the Dietary Supplement Health and Education Act (DSHEA). I believe, based on years of study, that such FDA antagonism even against ethically manufactured supplements stems from its close working relationship with the drug company giants. Like the FDA, the drug industry has sought for years to have supplements removed from the over-the-counter marketplace and transformed into prescription drugs which they alone could control and market and for which they could charge enormous prices, as is the case with any other drug. You seem to have played right into this effort. In your press conference, you alluded to expected opposition to your bill from the supplement industry. I suspect such opposition will be small compared to the opposition of the American public at large. In past decades, as the FDA, working with the drug industry, tried to gain complete control over the supplement industry, repeatedly the American people have fought back in vigorous campaigns, in true American fashion expressing their opinions to their elected officials in Washington. But the regulatory agencies in Washington never give up their dream of removing most if not all supplements from the free marketplace and turning them into restricted and expensive drugs, all to the benefit of the pharmaceutical industry and to the ultimate detriment of the public.

Ethically manufactured nutritional supplements when used appropriately are extraordinarily safe with considerable health benefits. We see this in our own practice daily, even with the most advanced, deadly of diseases. Furthermore, nutrients—again when manufactured and used appropriately—have in my long experience none of the terrible side effects of prescription items or even over-the-counter drugs. For example, it is estimated that 10,000 Americans die each year from bleeding resulting from intake of aspirin or over-the-counter anti-inflammatory drugs, yet the FDA does nothing to ban these products, which bring in untold profits to the drug industry. Nor to my knowledge have you ever held a press conference expressing your outrage over thousands of Americans tragically dying from aspirin use each year.

Certainly everyone would agree that an unethical company marketing potent drugs as supplements should be prosecuted to the full extent of the law, but again, the FDA already has such authority. It hardly seems reasonable, as could now be possible should your bill pass, to punish and perhaps even eliminate an entire industry because of a few renegade manufacturers.

Your bill, furthermore, seems to unravel the Dietary Supplement Health and Education Act (DSHEA) that provides protection from regulatory harassment for the many legitimate small supplement companies. In a flurry of misguided efforts to protect consumers, the FDA should not be given what it has long sought, the ability to regulate and control —and eventually, possibly even bankrupt—the supplement industry, all to the benefit of the drug companies. I believe your bill would allow the FDA to do just that.

I am astonished that without much apparent thought of the consequences, you would consider introducing such legislation. The American people, by and large, want their nutritional supplements, and they want these products freely available without FDA interference. Yes, of course they also want scientifically sound and ethically manufactured products, but the FDA and FTC can already act against improperly marketed supplements and supplements deliberately contaminated with drugs. And a company determined to spike their products will do so whatever the additional regulations imposed.

We do not need yet another power grab in Washington, all intended for our alleged “good,” and to help protect us from ourselves. As a more personal note, I will tell you that hundreds of my very sick patients are very distraught about this bill since your press conference announced its introduction, angry that you, of all people, would sponsor legislation that might possibly eliminate their life-sustaining supplements from the marketplace, and essentially condemn them to death—all in the name of consumer protection. The mere possibility of such a turn of events has upset them enormously. I will also tell you that as we learn more about this proposed legislation, however you may position it, my patients are already considering mobilizing to support your opponent in every way possible, financially, as volunteers – even perhaps holding a “sit-in” at your offices for the benefit of the press. That is how seriously they are taking this situation. And let me assure you these people are not part of some supplement company conspiracy against safe manufacturing practices, they are Americans—many of them incidentally veterans —with terrible disease who do not want interference with their treatment choice. I can understand their dismay. Perhaps I am wrong in my interpretation, but if this bill were ever to pass, the repercussions do seem potentially disastrous, in ways far beyond your assurance that this issue is a “no-brainer.”

I would be happy to talk to anyone in your staff about the unintended consequences apparent in this bill. As I read the information, in my opinion it appears that ultimately it protects nobody except the drug industry and provides professional athletes with a convenient scapegoat. It certainly would not protect the American public that has over the decades repeatedly shown it wants free access to nutritional supplements without FDA interference. Certainly, it will not protect my patients, who, frankly, did not need to hear of this bill, the thought of which has added enormous stress to their lives as they daily fight their life and death battles.

Sincerely,
Nicholas J. Gonzalez, M.D.
www.dr-gonzalez.com

The Dietary Supplement Excuse

By James Gormley, Senior Policy Advisor for Citizens For Health
via www.thegormleyfiles.blogspot.com

[With the DSSA bill, S. 3002, now up for vigorous debate, it’s worth taking a look back to this article of mine from 2007, as most of the same issues still apply]

On November 15th, 2007, home-run legend Barry Bonds was indicted for allegedly lying under oath to a grand jury about his use of performance-enhancing steroids.

In the New York Daily News coverage of the story, Victor Conte, founder of the Bay Area Laboratory Cooperative (BALCO) that allegedly supplied numerous world-champion athletes with performance enhancers, was quoted as speculating that “Bonds could have tested positive due to a contaminated dietary supplement.”

Right. Perhaps Conte was borrowing an excuse from nearby San Diego. On October 31st, The Canadian Press reported that San Diego Padres’ center fielder, Mike Cameron, was suspended for 25 games after testing positive a second time for a banned stimulant. Cameron reportedly said that he thinks he took a tainted supplement.

On October 5th, Olympic gold medalist, Marion Jones-Thompson, pled guilty to charges of making false statements to federal agencies in connection with two investigations, one of which was related to the BALCO steroid cases.

A Checkered Past
According to the Seattle Post-Intelligencer, the BALCO timeline extends back as far as 1988, when Conte was providing free blood and urine testing and dietary supplements to a group of athletes he referred to as the “BALCO Olympians,” whom he joined at the 1988 Summer Olympics in Seoul, Korea.

After 1996, Conte formed what he called the ZMA Track Club, which, according to the Seattle Post-Intelligencer,“served as a marketing tool and claimed among its athletes Marion Jones and Tim Montgomery.” According to the paper, “Bonds’ arrival in 2000 signaled even greater opportunities.”

According to USA Today, 2002 was when the federal investigation of BALCO began, followed by a raid of BALCO’s offices in September 2003 and a 42-count indictment against four men (including Conte) alleging a conspiracy to distribute anabolic steroids and misbranded drugs, in addition to money laundering.

New Battle for Dietary Supplement Health and Education Act (DSHEA)

Senators McCain and Dorgan Let Down Dietary Supplement Consumers

On Thursday, Feb. 4, 2010, Senators John McCain (R-AZ) and Byron Dorgan (D-ND) introduced The Dietary Supplement Safety Act (DSSA) of 2010. This bill would amend DSHEA, undermining, if not entirely eliminating, consumer access to valuable dietary supplements, according to Jim Turner, Citizens for Health Board Chair.

Over the next week, Citizens for Health will report in detail on specific sections of the bill, which would reverse supplements’ 100 year long status as foods, create onerous requirements for supplements not applied to other foods or even to prescription drugs, and wipe out significant numbers of small supplement manufacturers and sellers.

“This bill, typical of Washington’s ‘destroy the economy, wipe out consumer rights, and undermine individual health’ mentality,” says Turner, “thoughtlessly reinforces the costly, unresponsive, dangerous policies that have created an unsafe and depleted food supply and a bankrupt health care system.”

This bill takes power, choice, and self-determination from consumers and gives it to government. Urge your Senators to avoid co-sponsoring it. The people of Arizona and North Dakota, who believe in consumer rights, safe and healthy food, and responsible government, deserve better Senators. McCain is up for re-election in 2010 and Dorgan has announced he is not running for re-election. Let’s make sure health freedom and dietary supplement advocates win these seats.

James S. Turner is a partner in the Washington, DC, law firm of Swankin and Turner, formed in 1973, and Board Chair of Citizens for Health, the consumer voice of the natural health community. From 1968 to 1971, Mr. Turner worked with Ralph Nader, and wrote The Chemical Feast: The Nader Report on Food Protection at the FDA (Grossman 1970).

In 1975, he successfully opposed the Federal Trade Commission proposal to ban the words “natural,” “organic” and “health food” from all commerce. In 1990, he lobbied successfully—with many others—for passage of the “Organic Food Production Act of 1990”. In 1994, he worked with the newly created Citizens for Health to pass DSHEA. Congress received one and a half million communications supporting DSHEA.

Turner also led the team that persuaded FDA to approve acupuncture needles (1996); campaigned successfully against the 1976 Swine Flu program, which the government stopped for being dangerous; lobbied to legalize health claims for food; and wrote Making Your Own Baby Food (Workman 1974, Bantam 1975, 2nd expanded edition Workman 1976).

He recently co-authored, with A. Lawrence Chickering, Voice of the People: The Transpartisan Imperative in American Life (da Vinci Press, 2008)

Boston Globe Wrong on Vitamins, Supplements

By Neil Levin via www.honestnutrition.blogspot.com

circulation

Dietary Supplements Are Regulated

In its Nov. 2 editorial, the Globe complained that the FDA is “powerless” to police dietary supplements and called for a repeal of the Dietary Supplement Health and Education Act of 1994. I suggest that the editors read the law and see what it is that they would lose by doing so.

Mandatory Good Manufacturing Practices (GMP) were authorized by this law. GMPs control the manufacturing of all supplements, requiring quality controls, identity and safety testing. Federal GMPs are currently being implemented. No one in their right mind wants this to go away right when it is just getting started. Federal pre-approval of all new dietary ingredients (NDIs) is also required by DSHEA. Isn’t that close to what the editors suggest when they want pre-market approval of all new supplements?

Adulterated products are already banned by this law. And steroids and steroid precursors are specifically banned under another more recent law that was supported by the dietary supplement industry. DSHEA bans misbranded products, such as those containing hidden drugs, and offers them absolutely no protection. In fact, the misbranded products that the editors complained about are actually defined as unlabeled drugs by the FDA, not as dietary supplements, so technically DSHEA does not even apply to them. Let’s leave out the evildoers who deliberately hide illegal drugs in bottles misbranded as dietary supplements. What does that leave us with?

The vast majority of dietary supplement companies responsibly follow the law and do not have poor quality products. There are rarely cases of serious injuries or deaths from dietary supplements when you take away the products that are really illegal drugs made by outlaws who don’t care about the law or their own customers’ health. Responsible brands follow the new FDA dietary supplement GMPs, checking all ingredients for identity and purity and looking for contaminants and known adulterants. They truthfully declare all ingredients and correct dosages on the labels. They monitor product usage for adverse events and report serious ones to the FDA when they occur. They are not the criminals counterfeiting illegal drugs disguised as dietary supplements.

What part of this cries out for such severe regulation that pre-market approval of new formulas is needed? How will new laws stop lawbreakers when their actions are already clearly illegal? Pre-market approval in Canada is a joke; many ingredients and formulas are not available there even though American citizens freely enjoy their use without serious issues. Some American manufacturers have already pulled out of the Canadian market, while others offer only small selections of their lines because of the bureaucratic hoop jumping required for government approval. If DSHEA is repealed, many safe legal products providing much-needed nutrients will disappear while the lawbreakers continue to do business, with a net harm to public health.

http://www.boston.com/bostonglobe/editorial_opinion/editorials/articles/2009/11/02/police_these_pills_and_powders/

Pfizer Broke the Law by Promoting Drugs for Unapproved Uses

pfizer

Nov. 9 (Bloomberg) — Prosecutor Michael Loucks remembers clearly when lawyers for Pfizer Inc., the world’s largest drug company, looked across the table and promised it wouldn’t break the law again.

It was January 2004, and the attorneys were negotiating in a conference room on the ninth floor of the federal courthouse in Boston, where Loucks was head of the health-care fraud unit of the U.S. Attorney’s Office. One of Pfizer’s units had been pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration had never approved.

In the agreement the lawyers eventually hammered out, the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses.

New York-based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company’s lawyers assured Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes.

What Loucks, who’s now acting U.S. attorney in Boston, didn’t know until years later was that Pfizer managers were breaking that pledge not to practice so-called off-label marketing even before the ink was dry on their plea.

On the morning of Sept. 2, 2009, another Pfizer unit, Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra, a drug approved only for the relief of arthritis and menstrual discomfort, for treatment of acute pains of all kinds.

Lawmaking and the GAO Report: A Dose of Reality

By James Gormley via www.thegormleyfiles.blogspot.com

At the end of 2007, the U.S. dietary supplement industry recorded sales of $23.7 billion, according to Nutrition Business Journal. With roughly 33,000 dietary supplements on the U.S. market, it’s no surprise that with today’s nutritionally challenged diet there were 192 million Americans using supplements in 2007, a number that is expected to keep growing.

In addition to wanting to provide a basic nutritional “insurance policy” offered by a multivitamin, people take nutritional supplements for a variety of health-promoting reasons. In a 2000 survey conducted by Yankelovich Partners and commissioned by the Natural Products Association (NPA), seven out of 10 Americans take supplements because they make them feel better.

With the December 22nd, 2006, enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (often called the Serious Adverse Event Reporting [SAER] Law) and the August 24, 2007 implementation of the final rule on Current Good Manufacturing Practices (often called the cGMPs of federal GMPs, 21 CFR Part 111) — along with complementary and innovative industry self-regulatory programs—consumers have arguably never been better protected.

Not so, says a new report from the U.S. Government Accountability Office (GAO), entitled Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.

Broadly, the GAO report recommends: “…that the Secretary of Health and Human Services direct the Commissioner of the FDA to request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients and to clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.”

“I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements […] The FDA clearly needs more resources to give consumers real protection,” announced Rep. Henry A. Waxman (D-CA) upon release of the report.

His colleague, Rep. John D. Dingell (D-MI), added: “FDA needs the resources and adequate authorities [sic] so the agency can start addressing this problem.”

Among the report’s many conclusions, the GAO notably recommends that the Secretary of the Department of Health and Human Services (HHS) “direct[s] the [FDA] Commissioner” to require dietary supplement companies to “report all adverse events related to dietary supplements.”

The SAER Law already well protects consumers and has already demonstrated its ability to provide a signal to the FDA for action. The number of serious adverse event reports is in the hundreds, as compared to the hundreds of thousands of deaths and millions of serious adverse events for drugs and foods.

Why then would the GAO report require the reporting of all dietary supplement adverse events when this is not required for foods or drugs? This simply does not make any sense.

On top of this, the FDA itself doesn’t even think this makes sense. In its response to the report, the FDA wrote: “[…] it is not clear that all the information would actually enhance product safety.”

Finally, to top it off, did you know that the GAO, in fact, works for Congress? The head of GAO, the Comptroller General of the United States, is appointed to a 15-year term by the President from a slate of candidates Congress proposes, so clearly its reports are developed to provide support for agenda-driven “requests” from Senators and members of Congress, including the ones who requested this report. Ergo, it’s not always, or necessarily, the independent watchdog it’s often thought to be.

Gormley Take-Away: Lawmakers grandstanding and the GAO report notwithstanding, dietary supplements are by far much safer than foods and drugs. What happened to the facts?