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What (if anything) does “natural” mean?

"When I use a word," said Humpty Dumpty said in a rather scornful tone, "it means just what I choose it to mean -- neither more, nor less." Lewis Carroll, "Through the Looking Glass"

“When I use a word,” said Humpty Dumpty in a rather scornful tone, “it means just what I choose it to mean — neither more, nor less.”
Lewis Carroll, “Through the Looking Glass”

What does the term “natural” mean on a label? Does it mean anything? Should it mean anything? Good questions. And complicated ones, judging from the list of questions the FDA needs your help in answering.

The FDA has resisted defining “natural” in food product labeling, including whether foods that are genetically engineered, or contain genetically engineered ingredients, can use the term. Back in 1991, the agency set out to issue regulations but abandoned the effort and has since held to an informal policy that “natural” means

nothing artificial or synthetic (including color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.

The only official legal requirement for using the description “natural” on a food label is that it not be misleading or false, which is forbidden by the Food, Drug & Cosmetics Act of 1938. In that appetite-suppressing way of statutory language, “food” is defined by the Act as

articles used for food or drink for man or other animals, chewing gum, and articles for used for components of any such article.

For regulatory purposes, dietary supplements are also considered foods in most cases. (more…)

Posted in: Genetically modified organisms (GMOs), Legal, Nutrition, Politics and Regulation

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Regulating CAM Aussie Style

640px-Flag_of_Australia.svg
CAM proponents view National Health Interview Surveys recording the supposed popularity of CAM, an amorphous conflation of anything from conventional medical advice to mythical methods, as an invitation to unleash even more unproven remedies on the public. My interpretation is quite different. I see the same figures as proof that we are doing too little to protect the public from pseudoscience.

In fact, state and federal governments are acting as handmaidens to the CAM industry by legalizing practices and products that have insufficient proof of safety and efficacy and, in some cases, are so scientifically implausible that they can never meet that standard. The federal government keeps “integrative” medicine centers at major academic institutions and private foundations afloat with taxpayer money by funding research that has failed to improve public health or the treatment of disease, despite seemingly endless trials, because “more research is needed”.

As we shall see, Australia has a more effective regulatory system for dealing with CAM. And the advocacy group Friends of Science in Medicine (FSM), an organization with goals similar to our own Society for Science-Based Medicine, is keeping the government on its toes, investigating violations of the law on its own and reporting them. We in the US could learn something from their two recent successful campaigns attacking misleading health claims. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures, Guidelines, Legal, Naturopathy, Politics and Regulation

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Legislative Alchemy 2015: Another losing season for CAM practitioners

legislative-alchemy-image
One of the main, but perhaps underappreciated, reasons quackery thrives in the United States is that the states legalize it by licensing practitioners of pseudoscience as health care providers. These practitioners are placed under the regulatory jurisdiction of, well, themselves. I call the whole deplorable process Legislative Alchemy, and you can see all posts on the topic here. It gives practitioners an underserved imprimatur of state authority and leaves public protection from harmful practices to the oversight of those who are themselves engaging in the very same conduct. Each year, dozens of bills are brought before the state legislatures to establish initial licensure or, once that goal is achieved, scope of practice expansion.

Most attempts fail, but CAM practitioners are a dogged bunch, and they will come back each year until they get what they want. It took chiropractors about 60 years to become licensed in all 50 states. Acupuncturists are almost there. Naturopaths lag far behind, but are slowly gaining ground each year, even if it is only via practice expansion in states where they are already licensed. 2015 was a losing season for all, but not without advancement toward larger goals.

(more…)

Posted in: Acupuncture, Chiropractic, Diagnostic tests & procedures, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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Continued Battle over Homeopathy

Homeopathy - not medicine
The battle to rid modern scientific societies from the blatant and harmful pseudoscience of homeopathy continues. This past year has been overall a good one – in the US both the FDA and FTC decided to review their regulation of homeopathy. They have gathered their testimony and are now apparently reviewing everything. Their decisions on this topic are eagerly anticipated and could decide the fate of homeopathy for the next one or more generations.

Some success

In the UK the situation is also very positive. Their national health service is considering blacklisting homeopathy so that general practitioners cannot prescribe homeopathic products.

Success in the UK is largely due to The Good Thinking Society, founded by Simon Singh. They have been tirelessly campaigning against NHS coverage of homeopathy and are making steady progress. They are demonstrating that skeptical activism can be effective.

Likewise, SBM and the Society for SBM are having an impact in the US, mainly through persistent persuasive writing and being available as a resource to politicians, the press, and regulators. Members have personally consulted with the FDA, FTC, and staff of senators interested in the issue.

(more…)

Posted in: Homeopathy

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Holding the supplement industry to account: Can we learn from tobacco regulation?

When it comes to supplements, you can't trust what's on the label

When it comes to supplements, you can’t trust what’s on the label

The idea that “natural” products are safe and effective has been so effectively marketed to us that many don’t recognize it as a fallacy. Much of the supplement industry is built around an appeal to nature. Supplements are described as natural, gentle, and “holistic”. Medicine, especially prescription drugs, is the opposite. They’re “chemicals”. They’re risky and dangerous – just look at that list of side effects! Supplements are packaged beautifully, have impressive claims, and are for sale at Whole Foods. Drugs are hazardous: They may come in a plain vial, with warning labels, detailed information sheets, and cautious statements about their effectiveness. Is it any wonder that many consumers, when faced with health concerns or medical issues, instinctively think of supplements as a safer alternative? Purveyors of supplements and alternative medicine have leveraged this fallacy so effectively that it’s even guided the regulations that allow their sale. Regrettably, the result is a marketplace that puts consumers’ interests last. The supplement industry has completely stacked the odds against the consumer, challenging their ability to make informed decisions about their health. Most supplements on the market have never been properly tested for safety or effectiveness. And those that have been tested have largely been shown to be ineffective – or in the case of products like vitamins, often unnecessary. And while there are undoubtedly some ethical companies out there, the industry is regularly revealed to resemble a wretched hive of scum and villainy. Despite this, the industry has gone from success to success – in terms of sales, at least. In 1994 supplement sales were about $4 billion in the US. It’s now a $37 billion industry that is remains only lightly regulated – or largely unregulated. With recent action taken against fraudulent products, there are more questions than ever about how to force the supplement industry to make consumer protection a priority. A new paper in Drug Testing and Analysis makes a provocative suggestion: Local and state governments already regulate another hazardous product: tobacco. Can lessons learned from the tobacco wars improve the safety of supplements? (more…)

Posted in: Epidemiology, Health Fraud, Herbs & Supplements, Politics and Regulation, Public Health

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Brian Clement claims Hippocrates treatments “reverse” multiple sclerosis

Brian Clement

Brian Clement

American charlatan Brian Clement made another trip to Canada recently and was caught on audiotape claiming multiple sclerosis could be “reversed” at the Hippocrates Health Institute (HHI), where he serves as Director. This is yet another in a series of his misrepresentations about the effectiveness of the quack treatments offered at HHI. Indeed, Clement calls to mind the old joke about inveterate liars:

Q: Know how can you tell this guy is lying?

A: His lips are moving.

Once again, the Canadian Broadcasting Corporation (CBC), which has done an outstanding job exposing Clement and his mendacity, caught him in this particular fabrication. (The American media, by contrast, has largely ignored the story, even to the point of printing credulous puff pieces about Clement.) According to the CBC, it:

obtained a recording of a lecture Clement gave in September in Montreal where he said, “Last week, we had somebody at the institute that reversed multiple sclerosis.”

He went on to claim that many other people who visited his Florida spa, the Hippocrates Health Institute, saw similar results.

“A nurse that came to us two years ago was crippled, had braces on. By the time she left Hippocrates, she reversed the multiple sclerosis.

“And mainstream medicine, they think it’s remarkable. I’ve seen lots and lots of people over the years did that.”

(more…)

Posted in: Cancer, Health Fraud, Legal, Politics and Regulation, Science and the Media

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US Department of Justice Goes After Supplements

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

It is shaping up to be a good year for those of us advocating more effective regulation of supplements and unproven therapies in the US. The Food and Drug Administration (FDA) is reviewing its regulation of homeopathy, and recently also announced it is taking public comment on its regulation of the term “natural.” The Federal Trade Commission (FTC) is also reviewing the claims made by the homeopathy industry, and even gave a nudge to the FDA to fix its regulation.

Now the US Department of Justice (DOJ) is getting in on the fun:

USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products.

This action by the DOJ raises the stakes to a new level – criminal charges. While the FDA and FTC do the best they can, they often lack teeth when it comes to supplements. The FDA might issue a polite request and then escalate to a stern warning when companies step out of line. The FTC can issue fines which amount to little more than a slap on the wrist – the cost of doing business. Both agencies are playing whack-a-mole and losing.

(more…)

Posted in: Herbs & Supplements, Legal

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“Safe” dietary supplements can land you in the emergency room

Dietary supplements
If there’s one thing I’ve been consistent about, it’s that, however ridiculous all the other woo I routinely discuss here is—homeopathy, reiki, reflexology, I’m talking to you and your friends—herbal medicine and supplements might have value because they might have a physiological effect that is beneficial in treating or preventing disease. Of course, if that’s the case, it’s because the herb or supplement contains chemicals that act as drugs. They’re “dirty” drugs in that they are mixed with all sorts of other substances in the herb or supplement that might or might not have effects, which means that different lots of the herbs or supplements often have different activity, but they are drugs nonetheless. That’s why, for instance, doctors don’t tell patients to chew on foxglove leaves when they want a patient to get digoxin. Digoxin is a powerful drug with a relatively narrow “therapeutic window,” meaning that the difference between the levels of the drug in the blood needed for therapeutic effect are not very far from toxic levels; so predictable, reliable drug content is essential. I just learned a while ago that within the living memory of some older physicians digoxin actually was prescribed as crude extracts, which was very difficult and dangerous, hence the necessity of purification. In other cases, (such as Artemisinin, for which Youyou Tu was recently awarded the Nobel Prize in Physiology or Medicine), crude plant extracts do not contain sufficient quantities of the active component, necessitating its isolation, purification, and, in some cases, chemical modification to increase its absorption, stability, or activity.

One thing that proponents of herbal medicine and supplements often forget, though, is that if herbs or supplements can have potentially beneficial effects (albeit difficult to regulate effects due to the crude, impure nature of the extracts often used) because they contain drugs, then herbs and supplements can also produce adverse events, again, because they contain drugs. You can overdose on herbs and supplements. This point was recently reinforced by a new study by Geller et al. published last week in the New England Journal of Medicine (NEJM), entitled “Emergency Department Visits for Adverse Events Related to Dietary Supplements.” It was carried out by investigators from the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, and Chenega Government Consulting; and the Center for Food Safety and Applied Nutrition and the Division of Public Health Informatics and Analytics and the Division of Dietary Supplement Programs, Food and Drug Administration. The title pretty much tells you what the study is about, and what the study is about is that dietary supplements cause a lot of visits to the emergency room every year; 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year can be attributed to adverse events related to dietary supplements.
(more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Massage Therapy rubs me the wrong way

Massage therapy? Pranic healing? Polarity therapy? Zero balancing?

Massage therapy? Pranic healing? Polarity therapy? Zero balancing?

Back in my days of practicing law, one of my escapes from reality was a good massage. It was a great treat, exchanging the high-octane atmosphere of the law office for the soothing music, subdued voices and pastel tones of the treatment room. I could have stayed on that table for hours.

Little did I know just how much an escape from reality massage therapy would soon become.

About 15 years ago, when I called to book an appointment with my favorite therapist, a recorded message offered something called “ray-kee” – at least, that is how it was pronounced. I assumed it was just a form of massage and didn’t think anything about it. Then, at one session, while my feet were being rubbed, my massage therapist – an RN, no less – suggested I would be surprised at how often a sore spot actually correlated with a medical problem. She was talking about reflexology, of course.

Fast forward a few years. A new massage therapist and a new location, this time a “health center” (actually, a gym) owned by a local hospital. The massage therapist inquired whether I’d like to try “cranial sacral therapy“. “What’s that?” I asked. “Oh,” she said, “it would be hard to explain.” (She got that right.) She then proceeded to inform me that she had actually used it in one of our sessions. This alerted me to the possibility that informed consent was not part of the massage therapy protocol.

A few more years went by. Another therapist (also an RN), another location. I was pleased with her because I thought she did a good job and she also taught me some simple stretching exercises. To my surprise, in one session, she started pressing on the space between my toes because, she said, it corresponded with the (something, something – I didn’t get this part) of my neck. Reflexology again. (Are they now teaching reflexology in nursing school? I am beginning to wonder.) (more…)

Posted in: Acupuncture, Energy Medicine, Health Fraud, Politics and Regulation

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Medicine in the Magic Kingdom of Cascadia. On Naturopathy.

Beautiful Cascadia, where science goes to die.

Beautiful Cascadia, where science goes to die.

When the Pacific NW secedes from the Union it is to be part of a new country, Cascadia. The capital would be Portlandia, I suppose. Somehow, I think not. But when I watch the devolution of health care in Oregon, I think back to The Onion (?) when they reported that the United Kingdom was to be sold to Disney, being renamed as “The United Magic Kingdom.”

That is health care in Oregon due the steady insinuation of naturopathy and other pseudomedicine into real health care.

Oregon Health and Pseudoscience University

Growing up my alma mater was the University of Oregon Medical School. Since then it has undergone two name changes, first to Oregon Health Sciences University and then to the current Oregon Health & Sciences University (OHSU)—with, it should be noted, an ampersand. Not an ‘and’.

Perhaps they need one more name change, since they are not always that interested in the “Science” part of their name.

Some background is needed.

Portland has a trifecta of pseudoscience schools: Naturopathic (National College of Natural Medicine), Chiropractic (University of Western States) and ‘Oriental’ (Oregon College of Oriental Medicine).

Lucky us.

As an aside my kids let me know that the word ‘Oriental’ as used to describe people from the East, the term I grew up using, is persona non grata. I understand the reasoning. The proper term, they tell me, is Asian. So I have a mental cringe every time I see the name “Oregon College of Oriental Medicine”.

All three schools are steeped in pseudoscience and pseudomedicine, removed from known reality. As examples, the naturopathic school teaches homeopathy (and more), the chiropractic school teaches the subluxation complex, and the ‘Oriental’ (cringe) school teaches acupuncture. Reading the curricula of the schools suggests that there is no pseudomedical stone left unturned. (more…)

Posted in: Naturopathy, Politics and Regulation, Public Health

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