Part Two of our recent article on the laws threatening integrative doctors and integrative medicine—one of our most popular articles last month!
(If you’d like to read Part One, our discussion of the legal problems threatening physicians who use integrative medicine, click here.)
Federal Law for Sellers of Food, Supplements, and Medical Devices
The Federal Food, Drug, and Cosmetic Act (FD&C) gives authority to the FDA to regulate interstate commerce of supplements, drugs, and devices. According to the FD&C, by definition, only drugs can claim to cure, prevent, mitigate, or treat a disease [section 201(g)]. Nothing else may make that claim—certainly not a food or supplement.
To legally market a drug (that is, any substance that can claim to cure, prevent, mitigate, or treat a disease), it must go through the lengthy and expensive FDA drug approval process. Any violation—that is, any sale of a “drug” that is not FDA-approved—can lead to seizure of the product, injunctions against its sale and distribution, and criminal penalties, including imprisonment, for the manufacturer.
And as we have noted many times before, if a substance is natural, it is not patentable, and companies can only recoup their huge investment (as much as a billion on average, although estimates vary) in FDA approval if they can make it up through the high prices that patent protection makes possible. Therefore, natural products in supplement form will never be able to claim to treat disease, including cancer [section 201(ff)].
Why Only Patentable Drugs Are Considered “Safe”
The FDA’s control over patients’ access to cancer drugs was challenged in a 1979 lawsuit, United States v. Rutherford. Terminally ill cancer patients sued to stop the FDA from preventing the interstate shipment and sale of Laetrile—a modified form of amygdalin, a naturally occurring substance found in apricot pits as well as in other plants. The Supreme Court determined that the FD&C “makes no express exceptions for drugs used by the terminally ill…Exceptions to clearly delineated statutes will be implied only where essential to prevent ‘absurd results’ or consequences obviously at variance with the policy of the enactment as a whole.”
The Court supported FDA’s position that terminally ill cancer patients must be ensured therapeutic gain, which is only “guaranteed” by FDA approval. What this means in effect is that only non-natural and therefore patentable drugs which can be brought through the FDA process are “safe” enough to be used, even though natural remedies, which our bodies have evolved with, are generally safer or at least more predictable in their effects.
The further irony here, of course, is that the FDA has often approved drugs that are outrageously unsafe, causing so many deaths that they are subsequently pulled from the market and banned. The US National Poison Data System’s latest report records only a single death concurrent with supplement use—an “unknown dietary supplement or homeopathic agent”—with no deaths reported before 2009. On the other hand, it shows that, of all products to which we are exposed that might cause harm, pharmaceutical drugs caused 80% of fatalities—with 122 deaths attributed just to acetaminophen—an over-the-counter pain reliever sold under the brand name Tylenol.
Even though supplements cannot claim to prevent or treat disease, everyone knows that they may often be used for this purpose, either by consumers who have studied the scientific research, or by doctors themselves.
FTC Currently Violating the Law
The Federal Trade Commission code contains both a general prohibition of unfair or deceptive acts or practices affecting commerce [15 USC 45(s)] and a provision specifically prohibiting false or deceptive advertising of foods, drugs, devices, or cosmetics [15 USC 52]. In other words, the FTC has authority to stop false advertising of drugs and supplements as well as unconventional treatments it deems to be false medical cures—including cancer treatments.
Unfortunately, as we reported this past April, the FTC has recently created new and arbitrary requirements for ANY food or dietary supplement health-related claim—and is enforcing them—in direct violation of federal law. The FTC is now requiring two random-controlled human trials for any health-related claim—even so-called structure/function claims, which are permitted under the Dietary Supplement Health and Education Act of 1994 (DSHEA) without such trials. In response, ANH-USA and our co-plaintiffs, Durk Pearson and Sandy Shaw, filed a Petition for Rulemaking before the FTC. This petition, if denied, will lead to a litigation phase.
Often the FDA and the FTC work together to target supplement and food companies, which is precisely why the Free Speech About Science Act is so important. There are also federal criminal statutes that might affect the marketing and advertising of unconventional cancer treatments, like the wire fraud statute, which prohibits use of telephone, radio, or television to make “false representations for products and services,” and the federal smuggling statute.
Given all these legal risks, producers of natural food, supplements, and devices deserve our thanks.
21 comments
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Excellent article. Whether it is dangerous or not however we have an obligation to stand up and keep doing what is right, or we will end up with absolutely no liberties whatsoever. I intend to create a natural health website and I will not let these folks stop me from telling the truth. Corporations and government institutions have no right to dictate our lives or our health, and they will not if we stand up to them and refuse to cower in fear.
For those who are interested, Naomi Wolf wrote an excellent book that outlines the real story behind what is going on called “The End Of America, A Letter Of Warning To A Young American Patriot”. We thought Nazi Germany couldn’t happen again.. but it is and it’s right here in the (no longer) good ole U.S.A.
Best Regards,
Dr. John Michael Christian
http://www.johnmichaelchristian.com
http://www.spontaneousawakening.com
http://www.narcissisticabuserecovery.com
Please leave the drugs to the drug companies and leave our natural supplements alone and not under the control of man made drugs.
You pointing out some very important issues in these articles. However, your headline “Why Selling Natural Products is Such a Dangerous Business” greatly misrepresents both the content of the article and the actual risks to practitioners who sell supplements in their practices.
To support a conclusion that selling supplements confers legal risk by citing the 1979 laetrile case—and nothing else—is irresponsible journalism. Do you have any evidence that practitioners who dispense supps for basic health support, correction of nutritional imbalances or general health promotion are being hassled simply because they sell supps?
Far from helping the cause of health freedom, such sensationalistic tactics cause damage by creating negative attention & unnecessarily worrying physicians who might be interested in making natural products available to their patients.
A survey conducted by my company last year indicates that 13% of primary care physicians—and these were mostly mainstreamers–are dispensing. We cover a lot of integrative/holistic medical conferences and have not heard any signals suggesting a big federal or state-level crack-down on clinicians who dispense.
There are plenty of legitimate health & health-freedom issues with which to be concerned. You have not made a good case that crackdowns on practitioner supps sales is one of them. Perhaps this could be an issue down the road. But I’ve heard nothing that supports the conclusion implied by your headline.
You do a great disservice to practitioners, patients and professional-channel supplement companies by sounding false alarms.
Dear Erik, although Part One of this series focused on the legal risks to practitioners, this piece (Part Two) focuses on legal risks to manufacturers and retailers of dietary supplement – not to dispensing physicians.
Orthomolecular is the answer. Drugs kill.
Wondering: are particular foods—such as milk [calcium for strong bones], fruit juices [many claims], salmon/fish [fish oils] — and, in general, ALL foods which are advertised as “healthy/healthful—now also considered by the “drugs” by the FTC?
The despicable FDA is as much, or more, corrupt than the IRS. Inasmuch as the IRS may be responsible for an occasional suicide, the FDA is complicit in multitudes of murders..
DR. GRAHAM — the FDA employee in tthe FDA’s Office of Drug Safety who blew the whistle on VIOXX said in an interview about the FDA’s collusion with big Pharma:
‘In fact, when a former office director for Office of Drug Safety criticized me and tried to get me to change a report I’d written on another drug – Arava – he said to me and to a colleague who was a coauthor on this report that “industry is our client.” I begged to differ with him. I said, “No, industry is not the client, it’s the American people, the people who pay our taxes. That’s who we’re here to serve.” He said, “No! Industry is our client.”
Kinda sums up the problem: Why prohibitive testing costs preempt any company other than billion dollar companies from having their products passed by the FDA.
An unwholesome conflict of interest to the extreme. How many more VIOXX travesties and tradgedies must the public endure before we say ENOUGH!
And with the passing of the Food Safety Modernization Act (FSMA; S.510/HR2751), the FDA’s age old dream of ridding our market of supplements is closer to realization than ever before.
Gag orders in the Land of the Free?
Hmmmm….
Sounds unconstitutional to me, and not merely illegal.
To attack human health (some people can’t tolerate mainstream medications) should be a crime almost as severe as murder. Well not quite, but almost. And in some cases, yes equivalent, depending on the outcome.
Throw them in jail! They need to think about it.
Where are our representatives in congress? It is reported that some of the Big pharma drugs have killed so many people. Specific drugs. They know what these drugs are and they know who produced them. Why are there no large law suits against these companies? They can make their claims on television, radio and print. The FDA acknowledges that their drugs are killers by removing them from the market but does nothing to punish them. Our nation could be out of debt if big pharma were justly found guilty and fined in the right proportion for killing many, many Americans. It would be interesting to see if any one supplement did as much damage. What penalties? What cost to the supplement provider? We’ll never know…because it just doesn’t happen. The drug ccmpanies should remember the old advertisement that said, “It’s not nice to fool Mother Nature.
But it’s all about lobbying and paying off the FDA and our congressional representatives. How many millions of dollars are donated by the “little” people each year, hoping that the drug companies will find a “cure.” And it doesn’t happen. Why? Do you think they want to dry up their huge income? Not on your life! And I mean that literally.
God help us all. (And I mean that literally.)
Dorothy
Why doesn’t the FDA look into the amount of arsenic contained in apple juice? These apples come from other countries and are used in apple juice, specifically apple juice in those little boxes for children. Apparently this has been brought to the attention of the FDA, and they can’t be bothered with checking it out. Why not? How many people have died from an overdose of supplements? We hear every day about toxic prescription drugs that kill and/or do great harm to people. Yet these are legal? Where are the values of the FDA? Wherever there is money to be gained?
One of my lectures during my Ph.D. candiacy in 2007 was Dr. Rolan Lex. I imposed the question regarding the regulation natural medicines and his answer was similar to this. However, Dr. Lex indicated that the process of approval by the FDA would go alot smoother if the Physician or scientist had documeted clinical information that supported the finding for the natural medicine.
The future of Integrative medicine depends on the Physician or scientist research and commitment to providing competent clinical information that supports there findings. I must say from a personal and professional standpoint that I agree with this process, I do only because I know that even natural medicines have side effects just as phamacology. When I came up for dissertation in 2009, the medicine that I supported had 5 yrs clinical research with observation of the patients taken the natural medicines (See Ohio Medical Cannabis Act of 2012; Reid, et. al. 2009, 2011).
Don’t you know there is a nutraceutical company that has the money to do these human clinical trials and does? Don’t you know that they have over 177 patents? When you can isolate the plant fraction that produces the desired effect, you can patent that plant fraction. While I appreciate your article because I believe the FDA is wrong for preventing advertising the sale of natural products to help alleviate or cure disease, I know there is a company with the resources to deliver the products that change lives.
Sincerely,
Julie Berry, RN, BSN
Dear Senator,
The FDS’s proposed legulations for dietary supplements are onerous, unnecessary, and
would do damage to me and the country. Furthermore, the FDA’s intentions are counter to
the letter and spirit of DSHA, which became law 17 years ago.
I urge you and your colleagues to uphold this law and force the FDA to stop this illegal activity.
My freedom of choice as well as my access to nutritional supplements, which I depend on, are
at stake.
Sincerely, Geraldine Schafer
Thanks to the producers of natural fod, supplement and devises do get my thanks many times over. What a shame to have to worry about FDA and big Pharma will put a stop to them. That should be the people’s choice. Drugs or natural supplements.
It is my belief the cancer is a symptom of a weak immune system. Cure the immune system by feeding with all the essential food, vitamins and minerals it needs and remove all toxic poisons. [mercury, fluorine, lead, arsenic, Bt-toxin, glyphosate, 2,4-D, aspartame, MSG, trans-fats & oils, etc.] And then the immune system will take care of the cancer. Further comments at:
http://Opinion.FarTooMuch.Info/Cancer.htm
Thank you.
It is imperative that we as consumers find a way to force FDA to separate Pharmaceutical products developed in laboratories that are synthetic, generic, et, from products that are natural, from plants, herbs, vegetables and fruits and offered to the public as vitamins, oils, etc.
We must find a way to force government to force FDA to stop being biased by Big Pharm’s money and stop the vendetta against natural products that we the consumers want.
Let us all the the time to bombard our representatives with letters, em’s and phone calls until they listen.
I heard form my Senator that there is public comment period to FDA until 10/3. How do we access that? We need more letters going in// What else can we do?
Attention all Natural Health Product Manufacturers. Lets all start doing this. Since the FDA won’t let us state that our Natural Health Products (which we manufacture) can cure, prevent, mitigate, or treat a disease, we’ll start claiming the “OPPOSITE”. EXAMPLE: The label on a simple bottle of echinacea and goldenseal (treatment for cold) will say this: ‘At the first sign of a cold or flu, DO NOT TAKE THIS SUPPLEMENT TWO TIMES PER DAY WITH A FULL GLASS OF WATER OR JUICE”. Then all we have to do is educate our consumers that they should do exactly the opposite. OUR CONSUMERS ARE VERY SMART!