FDA Warns Companies Against Things that Help Fight Ebola

This is perhaps the best advertising money can’t buy. If you don’t already get these companies products, you might want to.

Remember it took the FDA 30 years to admit that vitamin C was helpful in combatting another virus…the common cold. BTW, I just started with doTerra. So if you want to get into that, please feel free to email me about it. Young Living has the MOST phenomenal product for helping with eye issues, it’s called Ningxia Juice and it has been tremendously helpful in halting ocular migraines. I can also help get you into that line, although I am not a member. Dr. Rima has been fighting the FDA longer than many of us have been alive. While I haven’t used their products, I think I am going to get some.

I guess I take the contrarian position to the US Federal Government’s agencies. If they are against it, there might very well be good reason to use it. If they recommend it, probably best to stay away from it. Also, my opinions, experiences, thoughts and existence have not been tested, approved, proven effective, nor sanctioned by the FDA.

Here’s the article:

FDA warns three companies against marketing their products as Ebola treatments or cures

 September 24 at 4:21 PM

The U.S. Food and Drug Administration sent letters to three companies this week, warning them against marketing their products as possible treatments or cures for Ebola. The letters, posted online on Wednesday, document multiple claims from the companies or their paid representatives that essential oils and other natural remedies can “help prevent your contracting the Ebola virus” and in at least one instance, “effectively kill the Ebola virus.”

There are currently no approved treatments, cures or vaccines for Ebola.

Natural Solutions FoundationYoung Living, and dōTERRA International LLC all produce products that were promoted on the Web as cures for a variety of ailments, all without FDA approval. The products in question, the letters note, are not FDA-approved drugs, yet their marketing makes the sort of claims that only approved drugs may make — that they can be used to treat, mitigate, prevent and cure diseases.

According to the three letters, those promotions — either on Web sites owned by the companies or on sites and accounts used by paid “consultants” promoting and selling the products — included Pinterest messages, Facebook postings and blog posts claiming products such as “CBD Organic Dark Chocolate Bars,” “Clary Sage” essential oils and the “Family Protection Pack” can do what has not yet been done: Treat, cure or prevent the deadly Ebola virus.

In one letter, to doTERRA, the FDA outlined the extent of those claims:

“Your consultants promote your above mentioned dōTERRA Essential Oil products for conditions including, but not limited to, viral infections (including ebola), bacterial infections, cancer, brain injury, autism, endometriosis, Grave’s Disease, Alzheimer’s Disease, tumor reduction, ADD/ADHD, and other conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Moreover, your consultants redirect consumers to your website, http://www.doterra.com, to register as a customer or member (i.e., consultant), and to purchase your dōTERRA Essential Oil products.”

According to the FDA, these promotions — especially ones related to Ebola — are inaccurate but not unexpected. “Oftentimes with public health incidences, like Ebola or even during H1n1, we see products that are marketed, often online, that claim to treat or cure the disease…without FDA approval,” FDA spokeswoman Stephanie Yao said in an interview, adding that “these sorts of things pop up” in almost any public health crisis.

In August, as the Ebola outbreak was accelerating in West Africa, the agency issued a preemptive warning to consumers, emphasizing that there is no FDA-approved vaccine or drug for the prevention or treatment of Ebola. The letters issued this week are something of a follow-up to that concern, Yao said, based on the results of online monitoring from the agency’s health fraud unit. The FDA will continue to monitor for similar claims.

Here is a sample of one such post, which was at the time this article was published available here:

Written by a paid consultant (referred to as a “member”) for Young Living, the post goes on to tout the possible benefits of a few oils sold by the company: “The Higley Essential Oil Reference guide mentions that the Ebola Virus can not live in the presence of cinnamon bark (this is in Thieves) nor Oregano. I would definitely add those two oils to whatever I was using.”

It adds: “I pray we don’t have to hear about this virus coming to the U.S. but if you travel outside of our country or know someone who goes to Africa or lives in Africa, maybe you could send them a care package of Young Living essential oils!”

In a statement provided to The Washington Post, a spokesman for Young Living said that the company was “cooperating fully with the FDA regarding its inquiry.” Young Living “members,” the statement continued, “are provided specific instructions on how to promote our products to their customers. In the coming days we will be contacting all our membership to ensure that they understand how to best use our products and remain compliant with regulatory directives.

“We have already contacted each of the Members cited in the FDA letter to help get them into compliance.”

One company targeted by the FDA, Natural Solutions Foundation, had materials on related Web sites promoting the company’s products as cures to several serious diseases and viruses, including Ebola.

On one YouTube video posted to the Natural Solutions Foundation account, the written text complains that the “WHO, FDA, the New York Times, etc., have gone on a rampage of disonformation [sic] to keep you in the dark about natural ways to dispose of dangerous microbes without damaging your beneficial bacteria.”

The video features Rima Laibow, the company’s medical director, claiming that the Natural Solutions product, Nano Silver, can “inactivate viruses like the HIV Virus, the Hepatitis B and C virus, Influenza viruses like H1N1, and Ebola virus.”

According to the FDA, all three companies have 15 days to respond to the documented violations and notify the agency of any corrective actions. If the companies are unable to correct those violations within 15 days, they’re required to explain why and provide a timeline for completion.

If they don’t take corrective action, the FDA could take any number of enforcement actions against the companies. Those include seizure, or possible criminal charges.

We’ve reached out to all three FDA-warned companies for comment.

The agency’s three letters are available here.

Abby Ohlheiser is a general assignment reporter for The Washington Post.

 

 

Study Indicates Glyphosate (Round Up) Doubles Chance of Lymphoma

With Amendment 1 on the ballot here in Missouri for August 5th, this is terrifically pertinent information. NO independent studies of long term exposure or ingestion have been done in the US!

Study: Glyphosate Doubles Risk of Lymphoma

Scientists at the International Agency for Research on Cancer have found what appears to be a strong link between pesticide exposure and a blood cancer called non-Hodgkin lymphoma.

Analyzing 44 individual research projects published since 1980, the scientists, writing in the International Journal of Environmental Research and Public Health, said that people exposed to the weed killer glyphosate, marked by Monsanto under the brand name Roundup, had double the risk of developing non-Hodgkin’s lymphoma. Those exposed to 2,4-D, another potent weed killer marketed by Dow Chemical, were 40 percent more likely to develop this disease.

The authors, scientists who work in the IARC Section of Environment and Radiation in Lyon, France, theorized that these pesticides were causing genetic mutations in white blood cells, thereby weakening the body’s immune system and ability to fight off disease.

Previous studies have observed that farmers with exposure to 2,4-D have experienced impaired immune systems.

Last month, EWG reported that research by scientists at the Arctic University of Norway had detected “extreme levels” of glyphosate on genetically engineered soybeans.

Crop scientists have genetically engineered soy to survive blasts of glyphosate so that farmers can use this chemical to get rid of weeds near crops. Over time these weeds have become resistant to glyphosate and grown hardier. In turn some farmers have resorted to spraying more of the pesticide to try to kill the tougher “super weeds.”

Genetic engineering’s early promise to reduce pesticide use now seems empty. The U.S. Department of Agriculture recently reported that herbicide use doubled—from 62 million pounds in 1996 to 128 million pounds in 2012. Glyphosate now represents more than 83 percent of the chemical pesticides used in the U.S. annually.

The IARC study was published April 23, as the U.S. Environmental Protection Agency was considering approving GE seeds of corn and soybeans engineered to withstand 2,4-D, a suspected carcinogen. If the EPA approves the new GE seeds and if 2,4-D is used to kill weeds on some of the 170 million acres of corn and soybeans grown in the U.S. annually, the USDA estimates that 2,4-D use is likely to triple, dramatically increasing people’s exposure to a pesticide that may cause cancer.

How can consumers reduce their exposures to these pesticides? When we eat GE foods, we are taking a dose of pesticides with them. Right now, we can’t tell which foods are genetically engineered. We have to guess. EWG believes people have the right to know which foods are genetically engineered. What can you do? Tell your elected representatives to support legislation to label GE foods.

Note from Food Revolution Network: Additional tools for reducing pesticide and GE food exposure are the Environmental Working Group’s Shopper’s Guide to Pesticides in Produce and the Institute for Responsible Technology’s non-GMO shopping guide.

No More Artisan Cheese for Americans

The FDA, Food Destruction Agency, has “clarified” their stance on cheese aged on wood. Short take, not allowed any longer in the US; and because of the lovely take over of all food granted them by the Corporate Board Members referred to as “Congress” under the Food Safety Modernization Act, no cheese imported to the US will be allowed to have been aged on wood either.

If you have thus far failed to see what is happening in this nation and across the world, I’ll sum it up for you. There will be no innovation and no creativity allowed. Our Heavenly Father’s creative attributes that He instills in us as we are created in His image is to be annihilated by rule, regulation, insurance premiums, or other “safety” measure.

This is an excellent article on the issue of cheese and the FDA. Don’t worry, whatever you desire to create/produce will be similarly regulated and destroyed…if it hasn’t already been regulated to death.

Game Changer: FDA Rules No Wooden Boards in Cheese Aging

A sense of disbelief and distress is quickly rippling through the U.S. artisan cheese community, as the federal Food and Drug Administration (FDA) this week announced it will not permit American cheesemakers to age cheese on wooden boards.

Recently, the FDA inspected several New York state cheesemakers and cited them for using wooden surfaces to age their cheeses. The New York State Department of Agriculture & Markets’ Division of Milk Control and Dairy Services, which (like most every state in the U.S., including Wisconsin), has allowed this practice, reached out to FDA for clarification on the issue. A response was provided by Monica Metz, Branch Chief of FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) Dairy and Egg Branch.

In the response, Metz stated that the use of wood for cheese ripening or aging is considered an unsanitary practice by FDA, and a violation of FDA’s current Current Good Manufacturing Practice (cGMP) regulations. Here’s an excerpt:

“Microbial pathogens can be controlled if food facilities engage in good manufacturing practice. Proper cleaning and sanitation of equipment and facilities are absolutely necessary to ensure that pathogens do not find niches to reside and proliferate. Adequate cleaning and sanitation procedures are particularly important in facilities where persistent strains of pathogenic microorganisms like Listeria monocytogenes could be found. The use of wooden shelves, rough or otherwise, for cheese ripening does not conform to cGMP requirements, which require that “all plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained.” 21 CFR 110.40(a). Wooden shelves or boards cannot be adequately cleaned and sanitized. The porous structure of wood enables it to absorb and retain bacteria, therefore bacteria generally colonize not only the surface but also the inside layers of wood. The shelves or boards used for aging make direct contact with finished products; hence they could be a potential source of pathogenic microorganisms in the finished products.”

The most interesting part of the FDA’s statement it that it does not consider this to be a new policy, but rather an enforcement of an existing policy. And worse yet, FDA has reiterated that it does not intend to change this policy.

In an email to industry professionals, Rob Ralyea, Senior Extension Associate in the Department of Food Science and the Pilot Plant Manager at Cornell University in New York, says: “According to the FDA this is merely proper enforcement of the policy that was already in place. While the FDA has had jurisdiction in all food plants, it deferred cheese inspections almost exclusively to the states. This has all obviously changed under FSMA.”

Ah, FSMA. For those of you not in the know, the Food Safety Modernization Act is the most sweeping reform of American food safety laws in generations. It was signed into law by President Obama on January 4, 2011 and aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

While most cheesemakers have, perhaps, begrudgingly accepted most of what has been coming down the FSMA pike, including the requirement of HACCP plans and increased federal regulations and inspections, no one expected this giant regulation behemoth to virtually put a stop to innovation in the American artisanal cheese movement.

Many of the most awarded and well-respected American artisan cheeses are currently aged on wooden boards. American Cheese Society triple Best in Show winner Pleasant Ridge Reserve from Uplands Cheese in Wisconsin is cured on wooden boards. Likewise for award-winners Cabot Clothbound in Vermont, current U.S. Champion cheese Marieke Feonegreek, and 2013 Best in Show Runner-Up Bleu Mont Bandaged Cheddar.

Wisconsin cheesemaker Chris Roelli says the FDA’s “clarified” stance on using wooden boards is a “potentially devastating development” for American cheesemakers. He and his family have spent the past eight years re-building Roelli Cheese into a next-generation American artisanal cheese factory. Just last year, he built what most would consider to be a state-of-the-art aging facility into the hillside behind his cheese plant. And Roelli, like hundreds of American artisanal cheesemaekrs, has developed his cheese recipes specifically to be aged on wooden boards.

“The very pillar that we built our niche business on is the ability to age our cheese on wood planks, an art that has been practiced in Europe for thousands of years,” Roelli says. Not allowing American cheesemakers to use this practice puts them “at a global disadvantage because the flavor produced by aging on wood can not be duplicated. This is a major game changer for the dairy industry in Wisconsin, and many other states.”

As if this weren’t all bad enough, the FDA has also “clarified” – I’m really beginning to dislike that word – that in accordance with FSMA, a cheesemaker importing cheese to the United States is subject to the same rules and inspection procedures as American cheesemakers.

Therefore, Cornell University’s Ralyea says, “It stands to reason that if an importer is using wood boards, the FDA would keep these cheeses from reaching our borders until the cheese maker is in compliance. The European Union authorizes and allows the use of wood boards. Further, the great majority of cheeses imported to this country are in fact aged on wooden boards and some are required to be aged on wood by their standard of identity (Comte, Beaufort and Reblochon, to name a few). Therefore, it will be interesting to see how these specific cheeses will be dealt with when it comes to importation into the United States.”

Ralyea continues: “While most everyone agrees that Listeria is a major concern to the dairy industry, it appears that some food safety agencies interpret the science to show that wood boards can be maintained in a sanitary fashion to allow for their use for cheese aging, while others (e.g., the US FDA) believe that a general ban of any wooden materials in food processing facilities is the better approach to assure food safety. At this point, it seems highly unlikely that any new research data or interpretations will change the FDA policies in place.”

In fact, many research papers do in fact conclude that wooden boards are safe. In 2013, the Wisconsin Center for Dairy Research published a paper on the subject, concluding: “Considering the beneficial effects of wood boards on cheese ripening and rind formation, the use of wood boards does not seem to present any danger of contamination by pathogenic bacteria as long as a thorough cleaning procedure is followed.” You can read the whole report on pages 8-9 by clicking on this link.

Interesting side note: Health Canada does not currently have any regulations prohibiting aging and ripening cheese on wood, so apparently if we want to eat most American or European artisan cheeses, we’ll need to drive across the border to do so.

So what’s next? The American Cheese Society has mobilized its Regulatory & Academic Committee to learn more about this issue, and to ensure its members’ interests are represented. The ACS promises to keep us apprised of developments. In the meantime, if you are a cheesemaker, and your operation is inspected and cited for the use of wooden surfaces, please contact the ACS office (720-328-2788 or info@cheesesociety.org).

 

Corruption in Science? You’re Kidding!

As anyone who follows the approval of FDA and USDA “science” knows, we no longer have much at all in the way of actual science. Instead we have black balling of those who don’t tote the corporate line, and science based studies that have nothing to do with legitimate science and the scientific method we are supposed to learn in school.

The following interview by Democracy Now! has clearly exposed the issue. Check it out:

Death by Regulation

I couldn’t possibly agree more with the author of the following article. He did a good job in going back through recent history and finding points that clearly show the insanity in which we now find ourselves regarding regulation of the simplest entrepreneurial effort.

The other day, Forbe’s, whom I take umbrage with over their continued support for GMO shill Henry Miller, did a good piece on the 1000 new businesses that sprang up in California due to the state allowing home food businesses to have a go at it without choking them to death with regulatory controls.

Less regulation is good for children and other living things…Unless of course it is lack of regulation over actual poisons like 24D.

My personal thoughts on this matter are that the regulatory system is effectively choking the spark of life out of us. It’s like replacing our inherent drive to create with the “Dao of Poo” summed up as, “Why bother?”

At any rate, here is the promised article. Hats off to the author, John Aziz!

By John Aziz | February 4, 2014
Yeah, it's tough out there kid.
Yeah, it’s tough out there kid. (Jim Weber/ZUMA Press/Corbis)
Over the last 30 years, it seems like it has gotten a little tougher for kids to start that most Norman Rockwell of ventures, the lemonade stand.

Back in the 1980s and 1990s there were a few instances of local governments shutting kids’ stands down for various reasons, although officials typically bowed to public pressure and allowed them to reopen.

In 1983, 6-year-old Ali Thorn’s lemonade stand in Belleair, Fla., was closed down after police received an anonymous complaint that her sign did not comply with city ordinances, but was quickly allowed to reopen.

In 1988, 9-year-old Max Schilling’s seven-foot high lemonade stand in Watchung, N.J., was shuttered after city officials claimed it was a permanent structure that sat too close to the street and threatened to fine him $500 a day. After a brief legal fight, Schilling’s stand was allowed to reopen.

In 1993, 12-year-old Sarah Knott and 13-year-old Margaret Johnson’s stand in Charleston, S.C., was shut down by police officers because they didn’t have a peddler’s license. However, after a public outcry, the city apologized to the girls and allowed them to continue.

More recently, though, local enforcement of lemonade stands seems to have grown stricter, or at least, more noticeable. The libertarian Freedom Center of Missouri has produced a map to show the locations of these incidents.

In 2010, 7-year-old Julie Murphy’s lemonade stand in Portland, Ore., was shuttered because she did not have a temporary restaurant permit, a license that carries a $120 fee, although that decision was later reversed with a Multnomah County chairman admitting that food inspectors may have overstepped their bounds, saying, “A 7-year-old selling lemonade isn’t the same as a grown-up selling burritos out of a cart.”

In 2011, in Midway, Ga., a lemonade stand run by Kasity Dixon, 14, Tiffany Cassin, 12, and Skylar Roberts, 10 was shuttered because they didn’t have a business license, a peddler’s permit, or a food permit, all of which would have cost them $50 a day to obtain for temporary use or $180 for the year. Despite national media attention and complaints from residents, the city wouldn’t back down.

And also in 2011, Caitlin and Abigail Mills’ girl scout cookie stand in Hazelwood, Mo., was closed for violating an ordinance banning the sale of items from a residential property. The girls’ family attempted to sue the city, but the case appears to have been dropped.

Let’s not overstate it, though. Lemonade stand-shutdowns are not reaching epidemic-like levels, and no one is going to cart off little Suzie to jail for selling cookies outside her house. That said, there is something absurd about shutting down lemonade stands, even if it’s still relatively rare.

The main risk of a tougher approach to children running food stands — and especially demanding that kids comply with costly licensing and strict city zoning laws — is that children will lose out on the entrepreneurial experience of running their first business, serving customers, and making money. If we want to have an entrepreneurial culture, where people innovate and take risks to build businesses, there has to be a certain amount of freedom and space for the young to learn these skills.

While navigating bureaucracy is definitely a useful entrepreneurial skill, expecting kids or their parents to fork out hundreds of dollars for a license to run their first business is punitive and anti-entrepreneurial. And every hour and dollar spent on inspecting or shutting down children’s lemonade stands on technicalities is an hour and dollar not spent on inspecting food safety in actual restaurants, food processing facilities, and stores — places where a lapse in food safety could expose hundreds or thousands of people to illness.

And while city zoning laws are useful for keeping heavy industry away from homes, selling lemonade or girl scout cookies is really a residential activity. Many of the world’s most famous businesses — Amazon, Apple, Disney, Google, Hewlett Packard — were started in garages. An entrepreneurial culture requires the freedom to start a business at home. If we stop businesses and businesspeople from developing, we lose the benefits that come down the road, like job creation and innovation (not that little Suzie’s lemonade stand will likely grow to rival Tropicana, but you get the point…).

The sooner cities and counties realize this, and stop wasting resources going after the entrepreneurs of tomorrow, the better.

###

FDA to Ban Transfats, but No Action on GMO’s…

In yet another case of avoiding the obvious, the FDA is blaming our obesity (skyrocketing levels since the massive infusion of GMO products) on transfats, and therefore, they are going to ban them. Next thing you know, there will be black market transfats. Potentially a CIA funded underground of trans peddlers could pop up and create yet another agency to deal expressly with outlawed food, or food like products. Why not just label GMO products and let people make their own decisions with actual knowledge? No, instead we’ll forcibly reduce salt, ban transfats, continue to attack real food, and tell you we’re protecting you and that GMO crops stave off starvation on food shortages….The Food Destruction Agency is working it’s science based principles, and they are the ones who said transfats were generally recognized as safe in the first place.

Whatever you do, do not trust the FDA on anything. This time they are accidentally right, but they are the ones who created the proliferation of transfats in the first place.

Government Power Grab: FDA To Ban Trans Fats

 Posted by Kristin Tate

695320912_1381547432OPINION:

The United States is over 17 trillion dollars in debt, the national unemployment rate is over seven percent, and one-sixth of the American population is on food stamps. But fixing those problems is just so hard! So, some courageous politicians have decided to spend time and money dictating what we should be allowed to eat. They do this in the name of “keeping us healthy.”

The Food and Drug Administration (FDA) has announced a plan to ban trans fats because they are a “threat to people’s health.”

The FDA is moving forward with this power-grab despite the fact that the amount of trans fats in the average American’s diet has declined rapidly in the last decade.

The food industry will be required to gradually phase out trans fats. Once they have been completely phased out, anyone who wants to use trans fats will be forced to get special permission from the FDA.

The FDA’s deputy commissioner for foods, Michael Taylor, said, “We want to do it in a way that doesn’t unduly disrupt markets.”

As of right now, the exact timeline for the phase-out has not been decided on.

Michael Jacobson, the director of the advocacy group Center for Science, said, “Six months or a year should be more than enough time, especially considering that companies have had a decade to figure out what to do… [The ban is] one of the most important lifesaving actions the FDA could take.”

The FDA claims that trans fats are horrible for your heart — worse than saturated fat — and can contribute to heart diseases.

This is true… But when did it become the government’s job to control what we eat? Have we become a complete nanny state?

Smoking can cause lung cancer — so why don’t we ban cigarettes? Too much sugar often leads to diabetes — let’s go ahead and ban sugar, too! Alcohol can contribute to liver failure — ban it!

You get my point. The government simply cannot ban everything that is a “threat to people’s health.”

America is supposed to be the Land of the Free. If people want to make poor food choices, they should be allowed to. Of course, it is unfair to make the rest of us pay for their heart disease and diabetes. This is why ObamaCare (the biggest government power-grab in a generation) must be overturned immediately. In a free country, government cannot dictate lifestyle choices, nor can it become the overprotective mommy and daddy of its citizens.

Freedom means having the right to make bad choices and then deal with the consequences ourselves.

Read more: http://benswann.com/government-power-grab-fda-to-ban-trans-fats/#ixzz2kLRuBacw
Follow us: @BenSwann_ on Twitter

Going After Supplements….Again

Seems Durbin just won’t be satisfied until everyone has to get their “nutrition” from his cronies:

The Dangerous Durbin Anti-Supplement Bill

October 30, 2013

dick durbin anti supplement billThe FDA can count on mainstream media to mislead the public. Let’s get the truth out and stop this bill. Action Alert!

Sen. Dick Durbin (D-IL)’s bill, S.1425, is meant to “improve the safety of dietary supplements by [requiring] manufacturers of dietary supplements to register dietary supplements with the Food and Drug Administration and to amend labeling requirements with respect to dietary supplements.” Sounds innocuous, doesn’t it? But as we reported in August, this is nothing but a smokescreen—a naked power grab for the FDA and an attempt to regulate safe dietary supplements as if they were dangerous FDA-approved prescription drugs.

A recent article in Newsday quotes “a top agency official” (probably FDA’s Division of Dietary Supplement Programs director Dan Fabricant, who is quoted extensively in the article) as saying that 70% of supplement companies have violated FDA’s manufacturing rules over the last five years—with the clear implication that such manufacturing violations somehow puts the American public at risk. There is no mention of the nature, context, or seriousness of these alleged violations, and no link to any official reports or documentation.

The article declares that the number of adverse events caused by supplements “outstrips” those triggered by prescriptions drugs. This is totally false. The Newsday article’s author, Delthia Ricks, tells us that approximately “6,300 people nationwide complained about adverse reactions to dietary supplements between 2008 and 2012, according to FDA statistics. But the actual number may be more than eight times higher, some experts say, because most people don’t believe health products can make them sick.” This “eight times higher” claim has no basis in fact, and no documented source. Even if it were true, this number is far less than for prescription drugs.

The 6,300 figure averages to 1,575 per year, which is extremely low considering that 157 million Americans—half the US population—take supplements. This is in comparison to 526,527 adverse events for prescription drugs, 275,421 of which had “serious outcomes,” including death.

Why would we want to let the agency regulate supplements as if they were drugs when the drugs they approve cause over 400 times the adverse events than supplements do? When the Government Accountability Office (GAO) looked at the number of adverse events for supplements at the request of Senator Durbin, it was unable to uncover anything alarming, as we reported back in March.

On the contrary, the GAO report showed that FDA-approved drugs caused 80% of Poison Control fatalities. More than 100,000 calls to Poison Control Centers, 56,000 emergency room visits, 2,600 hospitalizations, and nearly 500 deaths each year are attributed to acetaminophen (Tylenol) alone!

The Newsday article goes on to describe, in detail, the FDA’s authority to regulate the vitamin supplement industry, noting the agency’s inspection of supplement company facilities, and its ability to issue product warnings, recalls, and seizures and levy steep fines against companies that run afoul of FDA regulation. Inexplicably, the article then quotes Dan Fabricant as saying, “There is little the FDA can do to exercise more power over supplement safety without an act of Congress,” and concludes that FDA has “limited power” to regulate supplements. In what universe does that statement make sense?

The only way it makes sense is if mainstream media pieces like this Newsday article are viewed as propaganda: a concerted alliance between the media, the FDA, and legislators like Sen. Durbin to weaken the public’s determination to keep dietary supplements freely available. Lest this sound too conspiratorial, we need to remember that drug advertising is what keeps much of print media alive in these days of online competition.

The theme of adverse events is very much echoed in Durbin’s legislation. His bill requires that the FDA, together with the Institute of Medicine (IOM), compile a list of dietary ingredients (supplements) that might lead to adverse events, or are otherwise deemed risky in some way—based on completely arbitrary or nonexistent standards. Given the FDA’s profound bias against supplements, and the skewed, anti-science recommendations of the IOM’s vitamin D report, these are hardly trustworthy sources of guidance!

By the way, speaking of IOM and adverse events, why does the IOM absolutely refuse to study adverse events from vaccinations? In this case it holds that adverse events are meaningless because not studied, but then refuses to study them.

Returning to supplements, the FDA already has complete authority to keep them safe—it’s just a matter of enforcement, as the FDA’s Fabricant himself said when he worked for the Natural Products Association: “The barriers to enforcement are simple: [FDA] money, manpower, and will.” (You’ll note he doesn’t say “more regulation”!) He also made the distinction between the “legal, safe and healthy dietary supplement industry” and “the seedy, fly-by-night, unsafe world of illegal steroids,” and called on FDA, DEA, and other appropriate agencies to work together to enforce the laws that already exist. Most of the violations cited in the Newsday article are examples of bad manufacturing practices, which are already illegal and subject to FDA enforcement action. All the FDA has to do is enforce existing rules.

Another element in Durbin’s legislation is a greater restriction of health claims: he has said his bill is designed to stop “mislabeling products and making health claims that have no scientific basis.” This is more nonsense.

The vast majority of supplement health claims have plenty of scientific basis—just not the random-controlled trials (RCT) that Durbin and the FDA want. And there’s a very good reason for this: most natural products companies cannot afford to spend up to a billion dollars on RCTs, because in most cases that natural product can’t be patented, so the companies could never hope to make back their investment. In addition, many supplements should be taken with co-factors and so should not be studied in isolation like a drug.

Durbin knows all this. The demand for RCTs is just a backdoor way to get rid of most supplements entirely.

In the past, Dan Fabricant did not support greater restrictions of health claims. In response to IOM’s recommendation that dietary supplement health claims should be subject to the same scrutiny as pharmaceuticals, Fabricant said, “Trying to see foods through the same lens as isolated pharmaceuticals is impractical from a policy standpoint.” He also noted that many widely used general claims about how nutrients work, such as “calcium builds strong bones,” can’t be subjected to the same clinical evaluation as pharmaceutical drugs.

In other words, the FDA’s Fabricant said exactly what we’ve been claiming all along—that supplements are safe and the FDA needs no expanded powers—before he changed employers!

Action Alert! Please write to your senators immediately and tell them to stop Sen. Durbin’s frontal attack on your right to use supplements dead in its tracks! We don’t need this new legislation—all we need is for existing laws to be fully enforced. We need our access to nutritional supplements to be protected. Please write your senators today!

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