Sympathy for the FDA - If You Will
Recently, the FDA has been on a tear, going after companies for making medical claims for non-pharmaceutical products. This is something the FDA does every now and then -- kind of like a locust plague -- predictable that it will happen, unpredictable as to exactly when it will be. Here are just a few examples of the latest assault:
- On September 28th, the FDA issued warning letters to three companies that manufacture and market mouth rinse products accusing them of making claims that their products remove plaque above the gum line or promote healthy gums. According to the FDA, "These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated." The three companies/products involved are Johnson & Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corporation (CVS Complete Care Anticavity Mouthwash), and Walgreen Company (Walgreen Mouth Rinse Full Action).
- On September 9th, the FDA notified Enriching Gifts International that their products -- Plant Enzymes, Sterol Max, Pro Biotic with FOS™, Metabolic Complete™, Heart Algae™, Lightning Colloidal Silver™, and Aloe Ace Max™ -- were being promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. In their letter, the FDA went on to explain that the therapeutic claims on the company web sites established the products as drugs because they promoted them for use in the "cure, mitigation, treatment, or prevention of disease."
- On October 1st, the FDA posted an announcement recommending that people avoid consuming a product known as the Miracle Mineral Supplement (MMS) on the grounds that it was effectively bleach. As the FDA announcement said, "Some distributors claim MMS mixed with citric acid is an antimicrobial, antiviral, and antibacterial liquid that is a remedy for colds, acne, cancer, HIV/AIDS, hepatitis, H1N1 flu, and other conditions. But FDA experts say they aren't aware of any research that shows the product can effectively treat any illnesses." In addition, the announcement stated that "FDA experts say MMS is dangerous, and they're advising consumers to stop using the product immediately."
This spate of announcements raises several questions:
- Why now? Why is the FDA taking on these products and claims at this particular time, especially considering that these products have been available and making similar claims for years.
- Are the company claims true or not? And in the case of Miracle Mineral Supplement, is it safe, or is it dangerous as the FDA claims?
- Does the FDA care if the claims are true, or is there a different issue involved here?
- And finally, why is the title of this newsletter, "Sympathy for the FDA -- If You Will?"
At first glance, it might seem that with 10,000 employees, the FDA is a bloated bureaucracy capable of watching and punishing every single supplement company in the United States that fails to toe the party line -- at least that's the way it sometimes seems to those of us in the world of alternative health. But once you look at the responsibilities that Congress has assigned to the FDA, you quickly realize that they are dramatically understaffed. Specifically, Congress has made the FDA "responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health." This is an exact quote from the FDA website as to what their purview is.
One of the first things you might notice on this list is that nutraceuticals and herbal supplements do not even rate a mention in their list of responsibilities. Why? Quite simply, total sales for all herbal supplements in the US are about $4 billion a year. That sounds like a lot until you realize that just one single statin drug, Lipitor, produced $12.4 billion dollars in revenues for Pfizer in 2008 alone! Supplement sales/companies are like an annoying gnat to the FDA. And remember, the FDA's kingdom includes not just drugs, but also cosmetics, veterinary/pet products, and the nation's food supply. Again, although important to us, alternative health is a low priority to the FDA, one they are loathe to expend resources on. The bottom line is that it's easy to see that 10,000 agents aren't close to enough to truly monitor even one aspect of their primary responsibilities -- the food supply, for example -- let alone waste them on supplement companies (and mouthwashes, as cited above).
That means that the FDA has to function like a terrorist organization. They must rely on fear and uncertainty to assert their will -- especially when it comes to low priority items. In effect, they let a huge number of supplement companies get by with stretching and breaking the law for extended periods of time, and then when they least expect it, make a public show of assaulting a small handful of unlucky victims. The word then goes out through the grapevine that the threat from the FDA has risen to "red," at which point most companies start self-regulating, start "cleaning up their act" so to speak. In fact, the natural products industry has developed several large associations that actually work to support the FDA and government legislators in their work. The guiding principle seems to be a bit like Little Shop of Horrors -- if we serve the beast through self-regulation and informing on transgressors, then maybe it will leave our law-abiding members alone. It's an approach, but it may also be a deal with the devil. Only time will tell.
In the meantime, because its resources are insufficient, the FDA relies more on fear and intimidation than on actual oversight to control its empire. And this is especially true in the world of alternative health. And yes, Listerine and the other mouth rinse products are not alternative health products, but their marketing claims are fully in line with things regularly seen in the alternative health industry, so the FDA treated them in the same manner.
Are the claims true?
Before we answer this question, there's something you must understand. Proving the claims are true, even if they are, may not be to a company's advantage. Prove that a supplement actually produces a medical benefit, and it no longer qualifies as a supplement. It's now a medicine, subject to a whole different set of regulations, costly manufacturing requirements, and sales restrictions. If you get your product labeled a cancer cure, you might no longer be able to sell it except by prescription through authorized channels, which are completely dominated by medical doctors and the pharmaceutical companies and their sales reps. And what doctor is going to prescribe an herb over a drug that they've been paid hundreds of thousands of dollars to promote throughout their state? So alternative health companies play a delicate game -- alluding to benefits, without actually stating them so they can continue to sell their products to the public at large.
It also should be noted that it is the FDA that determines what claims are true and can therefore be promoted. For example, it is the FDA that determined that Prozac, Paxil, and Effexor can be sold as "antidepressants" despite studies that indicate they work no better than a placebo for most patients who take them. In fact, exercise works better than Zoloft according to a number of studies. And yet, the FDA allows these drugs, with all their harmful side effects, to be sold as medicines, complete with label claims -- but nothing for numerous herbal ingredients despite multiple studies backing their efficacy.
With that in mind, let's look at the claims.
I don't have time to cover all three mouthwashes cited by the FDA, so let's take one, Listerine Total Care Anticavity Mouthwash, and see what the story is. The big no-no according to the FDA is Listerine's claim that the product, "Fights Unsightly Plaque above the Gum Line." The FDA goes on to state, "No mouthwash with sodium fluoride as the active ingredient has been included or proposed for inclusion in any monograph for the antiplaque/antigingivitis indications claimed for Listerine Total Anti-cavity Mouthwash." Ergo, "As formulated and labeled, Listerine Total Anticavity Mouthwash is not generally recognized as safe and effective for the antiplaque indications in its labeling." But this is true only if one ignores the "inactive" ingredients in the Listerine formula. In fact, a long term study published in the Journal of the American Dental Association demonstrated that rinsing twice daily with Listerine Antiseptic mouth rinse is as effective at reducing plaque and gingivitis in areas between the teeth as flossing once daily. And this is hardly unique to Listerine. Most any good mouthwash with antibacterial properties will produce the same results. Bottom line: despite the FDA's refusal to accept them, the claims by the mouthwash companies are true. The problem is that the antibacterial ingredients in the rinses are considered inactive ingredients that therefore have no ability to combat bacteria at all.
Ahh, perhaps you're thinking, "Yes, but maybe the studies supporting these so-called antibacterial ingredients don't come up to the FDA's rigorous standards." And I would respond, "Do you mean like the rigorous standards they applied when approving the safety studies supporting the release of Vioxx and Avandia?"
Enriching Gifts International
The FDA letter to Enriching Gifts primarily chastises them for connecting benefits that may be associated with individual ingredients in their formulas with the formulas themselves. For example, the FDA cites the company for saying, "BROMELAIN [ingredient in product] ... • fights arthritis ... • fights cardiovascular problems, such as blood platelet aggregation, phlebitis, varicose ulcers, peripheral venous disease, blood clots, and heart attacks ... • fights viruses and bacteria ... • fights cancer and activates a tumor-fighting substance in the body called tumor necrosis factor (TNF)." And yet there are numerous studies to support each and every one of these assertions about bromelain. The FDA just chooses not to recognize them -- or hasn't got around to evaluating them.
Incidentally, the issue of bromelain brings up another key issue working against approval of non-proprietary ingredients: simple economics. It now costs anywhere from 110 to 800 million dollars (depending on whose numbers you use) to get a new drug approved. This makes economic sense if you have exclusive rights to the drug and can expect to earn several billion dollars a year from them for the life of the patent. But spend several hundred million as a company to get bromelain certified for its ability to "fight arthritis" and what is it worth? Because you can't patent bromelain, any company in the world can now pop bromelain into a pill and market it for arthritis relief based on your studies. And since they didn't have to "invest" several hundred million getting it approved by the FDA, they don't have to build those costs into their product. They can easily undercut your prices and drive you out of business. The bottom line is that in the world of alternative health all economic incentives are to keep ingredients such as bromelain listed as "inactive" with no medical claims attached to them. Cross the line and refer to studies that indicate it might actually do something, and you will receive a letter from the FDA. The only alternative is to wait -- many, many years -- until enough independent studies build up so that they can no longer be ignored. At which point, the FDA finally devotes resources to "approve" what has been generally known for several decades. And even then, it usually takes a big company to push the FDA into action. It wasn't until the behemoths Coke and Cargill got behind stevia (combined with erythritol) that the FDA finally allowed stevia to be used as a sweetener in foods.
Miracle Mineral Supplement (MMS)
The complaint against Miracle Mineral Supplement is of a slightly different order. Like the other two complaints, the FDA has problems with the health claims made for the product, stating in their announcement, "Some distributors claim MMS mixed with citric acid is an antimicrobial, antiviral, and antibacterial liquid that is a remedy for colds, acne, cancer, HIV/AIDS, hepatitis, H1N1 flu, and other conditions. But FDA experts say they aren't aware of any research that shows the product can effectively treat any illnesses."
In addition, the FDA questions the safety of Miracle Mineral Supplement. As they say in their complaint, "Distributor websites describe MMS as a liquid that's 28 percent sodium chlorite in distilled water. Product directions tell consumers to mix the sodium chlorite solution with citric acid -- such as, lemon or lime juice -- or another acid before drinking. When the acid is added, the mixture becomes chlorine dioxide, a powerful bleaching agent, says FDA expert Charles Lee, M.D. Lee says both chemicals are the active ingredients in disinfectants, and they have many other industrial uses."
So what about these claims by the FDA?
First of all, chlorine dioxide is NOT chlorine, and it is not household bleach (a mixture of sodium hypochlorite and sodium perborate)! Let me restate this, since the FDA seems to be implying that it is when they refer to it as "Potent Bleach": chlorine dioxide is not chlorine, and it is not household bleach. In fact, chlorine dioxide is used as a safe replacement for chlorine in water treatment systems, and it does indeed kill a wide variety of bacteria, viruses, spores, and other pathogens. And as to its safety, the EPA released a report attesting to the safety of chlorine dioxide and all its metabolites -- as have numerous studies. (Note: chlorine dioxide can cause lung irritation, but that is not an issue when consumed in water.)
The FDA bolsters its objections by stating that sodium chlorite and chlorine dioxide "are the active ingredients in disinfectants, and they have many other industrial uses." But if that's a valid objection, how can they allow propylene glycol, the antifreeze you put in your car, to be used in everything from cosmetics to pharmaceutical drugs? And for that matter, what about oxygen? It too is used as a disinfectant and has many industrial uses. Anyone think breathing oxygen is unhealthy? The bottom line, though, is that just because something is used as a disinfectant or industrial chemical doesn't necessarily make it unhealthy to use in a supplement. How it's used and how much is used matter. The FDA knows this and yet still chose to use it as a false argument against MMS. Not good!
The FDA concludes its arguments by stating, "FDA has received several reports of consumers who got sick from drinking the MMS and citrus juice mixture. The reports say consumers suffered from nausea, severe vomiting, and life-threatening low blood pressure caused by dehydration." I have two issues with this statement. First, what percentage of people are we talking about; was it verified that MMS caused the problems; and did they follow directions or deliberately overdose thinking to "maximize" benefits? And second, the FDA's concern would be more touching if they published a similar announcement for aspartame, which has generated more complaints of severe side effects (everything from tumors to blindness) than any other substance in FDA history; and yet, instead of publicizing this fact, the FDA continues to maintain that it is safe for consumption. There are many ways to describe this contradiction; the gentlest would be to call it a "double standard."
So what's the bottom line on Miracle Mineral Supplement? Does it work as promised? I've never tested it so I can't say, but there is scientific evidence to indicate that it might do at least some of what's promised. Does it cure cancer and AIDS as some websites proclaim? Not likely -- at least there is no convincing evidence currently available that indicates it does so. On this point, at least, the FDA's position is correct.
Is it safe? If used as directed, it appears to be far safer than aspartame. In any case, the purpose of this newsletter is neither to endorse nor trash the product -- merely to analyze the FDA's response to it.
Does the FDA care if the claims are true, or is there a different issue involved here?
The simple fact is that the FDA doesn't really care if the claims are true or not. Again, like any good terrorist organization, the question is not whether your position has any validity -- it's whether it inspires fear so that the objects of your campaign modify their behavior according to your desires. It's a control issue -- the ability of an undermanned force to insinuate its will on a much larger, better funded army. Match the FDA's 10,000 employees against a single large MLM company with 500,000 distributors (Amway alone has 3 million distributors), plus all of the companies selling lotions and potions on the internet and in stores, and you begin to see the scope of the problem for the FDA.
On the other hand, the FDA certainly has a bias in favor of pharmaceutical drugs. They let pharmaceutical companies get away with murder…literally. And in one of my "favorite" policies, they allow doctors to make health claims for drugs that have never been tested or approved by anyone -- based entirely on anecdotal evidence. And we're not talking about hundreds of years, or even decades of anecdotal evidence involving millions of users as can be found with many traditional remedies. We're talking about anecdotal evidence experienced by as few as one or two doctors over a few weeks. It's called off-label usage, and the standards are getting looser all the time! One doctor observes what they see as a beneficial side effect of a drug; they write it up; and instantly every doctor in the country can now prescribe the drug for that benefit -- without ever testing its efficacy or safety for that use! What alternative health companies wouldn't give for that privilege!
But bias is not conspiracy. Many in the alternative health community believe that there is a grand conspiracy between the FDA, medical doctors, and the pharmaceutical companies to crush the alternative health industry. The simple truth is that you don't need a conspiracy when many of the top people in the FDA and the pharmaceutical companies regularly move back and forth between high level positions in each group. Self-interest, greed, and the old-boy network are more than adequate to explain their actions. It also doesn't hurt when the doctors advising the FDA on what drugs to approve happen to be stockholders in the pharmaceutical companies submitting those same drugs for approval. All in all, the supplement industry is too small to warrant a conspiracy against it. It is more a pissant irritant to the FDA and the pharmaceutical industry than a substantive threat. Nonetheless, if it weren't for the passionate support of holistic adherents and their constant hectoring of the FDA and Congress, the FDA would be only too happy to see the alternative health industry simply go away -- just so they wouldn't have to deal with it. Given that they can't make it go away, they try and do the next best thing -- throttle it, handcuff it, and control it through fear and intimidation rather than with bodies on the ground.
Sympathy for the FDA
Now, I titled this newsletter, "Sympathy for the FDA." After reading this newsletter so far, you might be wondering how I could possibly have any sympathy for the FDA. The simple truth is that they have an impossible task.
- They are short of both money and personnel to effectively do the catch-all job that Congress has assigned them.
- They catch holy hell every time anything goes wrong such as an E. coli outbreak in bagged salads. (No wonder they want to see all food irradiated -- just to be done with the problem, long-term health consequences be damned.)
- As often as not, they can't win no matter what they do. Genetically modified food is a great example. Growers and grocery stores are pressing hard for its widespread approval -- with no labeling requirements. On the other hand, consumers and that part of the food industry involved in exporting their goods to countries where GMO foods are either banned or vehemently opposed by consumers just as adamantly don't want GMO foods to go unlabeled since it would taint their products by association. As far as the FDA is concerned, they're damned if they do and damned if they don't. So like any good bureaucracy, they keep straddling fences, calling for public meetings, and pushing their decision out into the future, thereby making no one happy.
- And when it comes to alternative health, they are at a total loss. Coming from a pharmaceutical/medical bias, they have no understanding or feel for the industry or its products. For the most part, they view it all as mumbo jumbo and cannot understand how so many people buy into it. And yet they are charged with overseeing it. So they make a botch of it. And no wonder so many people on the internet virulently loathe them and rail against them. It's as if the owners of the National Football League were suddenly put in charge of international soccer (football). For the most part, they don't like the game, have no feel for it, don't understand it, and view it as competitive to their primary interest -- American football. What could they possibly do but make a mess of it and make everyone angry in the process.
All that said, I would advise my colleagues in the industry to keep one thing in mind -- that as much as we may hate what the FDA does when it comes to alternative health, we actually have more choices and more options available to us in the United States than in almost any other major country in the world. So every now and then, between our battles with their outrageous rulings and double standards, maybe we should send them a kind thought -- a little sympathy for the devil, if you will.
PS: On Oct 14th, the FDA sent out notices to eight companies that sell heavy metal chelation products. And the locust swarm continues!