Currently browsing posts about: Supplements

Today’s New York Times has a front-page story about how the FDA knew that certain weight-loss supplements contained unlabeled amphetamine-like substances but did nothing about it, perhaps because its head supplement official came from the industry (and has since returned to it).

Let’s start with the science.

In 2014, Pieter Cohen and his colleagues noted that several athletes had been disqualified from competition after tests found evidence of a methamphetamine analog (N,α-diethyl-phenylethylamine) in their urine.  The athletes said that the chemical must have come from their workout supplements.  Cohen et al. tested the supplements and identified the analog as one with entirely untested stimulant, addictive, or other adverse effects in humans.  They recommended its immediate removal from all dietary supplements.

Earlier that year, the FDA reported that 9 of 21 supplements containing Acacia rigidula to test positive for varying amounts of another methamphetamine analog, β-Methylphenethylamine (BMPEA).   The FDA investigators said this compound could be misidentified as amphetamine during certain kinds of analyses, but did not identify the products found to contain BMPEA.

Cohen et al. then did their own tests of the kinds of supplements the FDA had tested.  

The stimulant was present at quantities such that consumers following recommended maximum daily servings could consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements.

The New York Times explains the context:

The controversy comes at a time when the supplement industry is under increased scrutiny. Last week, 14 state attorneys general, led by Eric T. Schneiderman of New York, called on Congress to provide the F.D.A. with more power to regulate supplements. Mr. Schneiderman’s office in February accused four major retailers of selling contaminated herbal supplements, and one of the companies, GNC, has agreed to extensive new testing and quality control procedures for its store-brand herbal products.

This brings us to the politics.

The supplement industry, of course, is doing everything it can to oppose and stop Schneiderman’s work.

Recall that Congress passed the Dietary Supplement Health and Education Act in 1994, essentially deregulating the industry.  The act allowed absurd health claims for supplements and essentially removed much of the FDA’s authority to regulate these products.

The result was an increase in sales despite remarkably little evidence for efficacy.

As for conflicts of interest at FDA:

• Daniel Fabricant, the head of the FDA’s dietary supplement division at the time this was happening, came to the agency from the Natural Products Association, “Over 75 years of serving the natural products industry.” He has since left the FDA and now heads the NPA.
• The NPA spent nearly $1.5 million on lobbying in 2013 and 2014.
• The current head of the FDA’s dietary supplement division, Cara Welch, also came to FDA from the NPA.

Since DSHEA, the dietary supplement industry has gotten a pass.  Suggestions:

• Congress should rescind DSHEA and give the FDA the authority to regulate supplements as it does food.
• The FDA should appoint officials who are independent of the industries they are supposed to regulate.

I still quaintly read the paper copy of the New York Times so I know that the left column of yesterday’s  front page—judged by the editors as the second most important story of the day—was devoted to yet another exposé of supplement fraud.

The New York State attorney general did some sophisticated testing.  His report concludes that major supplement retailers—GNC, Target, Walgreens and Walmart—are selling herbal supplements that do not contain what the labels say they contain or contain unlabeled ingredients that could be allergenic.

The examples are either amusing or shocking, depending on point of view:

• A popular store brand of ginseng pills at Walgreens, promoted for “physical endurance and vitality”…contained only powdered garlic and rice.
• At Walmart…ginkgo biloba, a Chinese plant promoted as a memory enhancer, contained little more than powdered radish, houseplants and wheat — despite a claim on the label that the product was wheat- and gluten-free.
• Three out of six herbal products at Target — ginkgo biloba, St. John’s wort and valerian root, a sleep aid — tested negative for the herbs on their labels. But they did contain powdered rice, beans, peas and wild carrots.
• And at GNC…it found pills with unlisted ingredients used as fillers, like powdered legumes, the class of plants that includes peanuts and soybeans, a hazard for people with allergies.

I’ve been writing about this kind of thing for years, but two aspects of this story are news.

• First, the state is doing what the FDA ought to be doing if its hands weren’t tied by DSHEA, the Dietary Supplement Health and Education Act of 1994.  That act essentially deregulated dietary supplements.
• Second, these are not some fly-by-night supplement sellers.  They are major retailers.  The supplement industry’s argument that only a few unscrupulous small supplement makers are cheating on ingredients doesn’t work in this case.

Why don’t people stop taking supplements when they hear things like this?

The major proven benefits of supplements are their placebo effects.  The actual ingredients make no difference.

The obvious conclusion is that if you must buy supplements, buy the cheapest ones.  But that doesn’t work either because more expensive supplements produce stronger placebo effects.

Placebo effects are great things, and I’m for them.  But caveat emptor.

Related documents

• The 2013 New York Times article that led to all this
• The attorney general’s cease-and-desist letters
• What’s in those supplements?
• Letters Outlining What Was Found in Herbal Supplements

Ebola is much in the news, and for good reason.  It is highly contagious, difficult to contain, and deadly.

In food studies, we say that food is a lens through which to view the most important problems of society.  Here are some thoughts on the food politics of Ebola.

Dietary Supplements for Ebola Prevention or Treatment

The Council for Responsible Nutrition, the trade association for supplement manufacturers, has found it necessary to issue an advisory on use of dietary supplements to prevent or treat Ebola infections.

The American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA) are therefore endorsing the following unified advisory for marketers and retailers, as well as for consumers of dietary supplements:

• Marketers and retailers of dietary supplements are urged to refuse to stock or sell any supplements that are presented as treating or curing Ebola virus disease, or preventing Ebola virus infection.
• Marketers and retailers should refrain from promoting any dietary supplement as a cure or treatment for Ebola virus disease.
• Anyone who believes they may have Ebola virus disease or may have come in contact with the Ebola virus should contact a healthcare professional immediately. The Centers for Disease Control and Prevention has more information on Ebola virus disease and the proper actions to take if you suspect you are ill.

The knowledge that no known treatment exists for Ebola has not stopped supplement manufacturers from advertising the benefits of their products for this infection.

FDA Warning Letters

The FDA has stepped in and issued warning letters to three manufacturers marketing their products as possible treatments or cures.  The FDA letters, which make interesting reading, went to:

• Natural Solutions Foundation
•  Young Living
• dōTERRA International LLC

Marketing of Nutritional Supplements

A simple Google search of “supplements Ebola” turned up this kind of information this morning:

The Ebola virus can be destroyed naturally – despite what you’ve been told To date, not a single virus has been tested that is not inactivated (killed) by a large enough dose of vitamin C (ascorbic acid). Many other antioxidants have similar virucidal effects, but vitamin C appears uniquely to be of greatest potency and clinical efficacy, as its simple chemical structure allows for it to be disseminated throughout the body with little restriction… Vitamin C is both very potent and optimally bioavailable in accessing any viral infection.

And this:

The substances in the Natural Allopathic protocol for Ebola offer a power unequalled in the world of medicine that we can harness to save many lives of people infected with Ebola…. Magnesium salts, sodium bicarbonate (baking soda), iodine, selenium and vitamin C are concentrated nutritional medicinals that have been used in the direst of medical circumstances…The core of the Natural Allopathic protocol redefines the way emergency room and intensive care should be practiced on Ebola patients with proven fast-acting, safe, concentrated and mostly injectable nutritional medicines. If the Ebola infection truly gets out of hand, it is comforting for parents to know that they can legally administer these same medicinals if infected people are treated at home. All of the Natural Allopathic Medicines can be also taken orally or used transdermally (topically) to almost the same effect if treatment is started early enough.

How Can Supplement Makers Do This?

The ability of supplement manufacturers to claim health benefits for their products, and mostly get away with it, is a result of congressional action in passing the Dietary Supplement Health and Education Act of 1994 (DSHEA), which essentially deregulated these products.

Twenty years later, the supplement industry is deeply divided between responsible and irresponsible manufacturers, both allowed by law.

As the president and CEO of one supplement company puts it,

The industry of 1994, roughly $8 billion in sales, has experienced compounded double-digit growth every year since DSHEA became law…DSHEA opened the door to growth, innovation, new science, new discovery and a nation of wanting consumers enchanted with the thought that there are natural solutions to their individual health needs…20 years later, it’s time to take a hard look at what DSHEA doesn’t provide to the industry today. The barrier to entry into this industry continues to have no hurdles; DSHEA does not define the boundaries of consumer trust… The generations of today, and the generations of tomorrow will demand transparency, they will demand efficacy, and they will demand quality and safety from all of us.

Clearly, they aren’t getting that now.

Other Connections to Food Politics

Chocolate

Politico writes:

EBOLA THREATENS WORLD’S CHOCOLATE SUPPLY:  Ivory Coast, the world’s largest producer of cacao, the raw ingredient in M&Ms, Butterfingers and Snickers Bars, has shut down its borders with Liberia and Guinea, putting a major crimp on the workforce needed to pick the beans that end up in chocolate bars and other treats just as the harvest season begins… the outbreak already could raise prices…Prices on cocoa futures jumped from their normal trading range of $2,000 to $2,700 per ton, to as high as $3,400 in September over concerns about the spread of Ebola to Côte D’Ivoire.

Food safety

Food safety lawyer Bill Marler points out that Ebola started out as a foodborne illness.    Its most likely source was infected bushmeat that transferred the virus to human handlers.

Following standard food safety procedures is always a good idea while hoping that health officials get this epidemic under control.

Section 7606 of the 2014 Farm Bill says that notwithstanding the Controlled Substances Act, The Safe and Drug-Free Schools and Communities Act, and other laws that govern the cultivation of marijuana, it is now OK for state agriculture departments and universities to grow “industrial” hemp for research purposes.

Industrial hemp, the Farm Bill says, means “the plant Cannabis sativa L…with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis.”

To put this in context: the average THC potency of domestically grown recreational hemp  (a.k.a. marijuana) is about 6 percent, but can go much higher.

With so little THC in industrial hemp, why would anyone want to bother with it?   Textiles of course, but also medical purposes and dietary supplements.

Even a little THC, apparently, goes a long way.

The New York Times reports that companies are growing industrial hemp to make hemp oil as a treatment for epilepsy.

On the legalities of hemp oil, The Times explains that the

Drug Enforcement Administration is offering few clues, insisting in public statements that while it is willing to allow marijuana sales in states that have legalized the drug, it might step in if growers try to sell beyond state borders…Any chemical that comes from the plant is still a controlled substance…When we get into hemp, it gets a little squishy, but it still is illegal.

Squishy?  Growing and using industrial or recreational hemp is illegal in America except in states that have made hemp legal or quasi-legal.

For example, New York State recently passed a hemp bill that would set up pilot programs for the production of industrial hemp.

At least one company is growing hemp in Colorado for use in dietary supplements.   At a trade show last year, it displayed US Hemp Oil promoted for its content of CBD—cannabidiol, a non-narcotic fraction of the hemp plant.

The company insists that CBD is a legal ingredient of dietary supplements.

Hemp, it argues, is a vegetable:

The pure oil is considered GRAS [generally recognized as safe]. Under the United States Uniform Tariff Code they tax and code hemp as a vegetable. I don’t know anything that’s a vegetable that isn’t GRAS. When we import it, it is always considered a vegetable, so that’s what we use in our declaratory actions…in March of last year Canadian company Abattis announced plans to bring a CBD-infused kombucha drink to market.

However and whether CBD works for medical purposes, everyone expects industrial hemp to be a huge cash crop for its textile and health food uses.

This is especially a boon for Kentucky, and it’s no coincidence that Kentucky Republican Senator Mitch McConnell spearheaded the hemp provision through the Farm Bill.

The boon-for-Kentucky Website provides a long list of potential applications for industrial hemp, ranging from textiles to cosmetics to auto parts.

Proponents of CBD provide an even longer list of diseases for which industrial hemp’s CBD is a treatment option.  There isn’t much research on the physiological effects of CBD.  This makes industrial hemp perfect as a dietary supplements.  It might do something.  That’s all you need for supplement marketing.

The legal battles will be fun to watch.  Stay tuned.

In the meantime, there is hemp cereal—organic of course.  Enjoy!

Skeptic of the value of dietary supplements that I am, I cannot help feeling sorry for Herbalife.

The company sells protein shakes and snacks, vitamins and dietary supplements, and energy and fitness drinks which, it says, “combined with healthy eating and exercise, can help you lead a healthy, active life.”

Yes indeed, healthy eating and exercise will do that for you every time.

But Herbalife has become the victim of a bizarre hedge fund bet and its consequences.

In what is one of the most blatant conflicts of interest besetting a food product, a hedge fund manager, William Ackman, made a billion dollar “short” bet that Herbalife’s stock would fall.

When the stock did not do so immediately, Mr. Ackman set out to destroy the company’s reputation to force its stock down.

He even got members of Congress, including Senator Edward Markey (Dem-Massachusetts) to call for an investigation of the company’s marketing practices, an action that caused a 14-point drop in the stock.

This decidedly unsavory story was the subject of a New York Times investigative report yesterday: “Staking $1 Billion That Herbalife Will Fail, Then Lobbying to Bring It Down.”

The company has grown into a global powerhouse, with a worldwide team of more than three million so-called members and distributors who operate as independent contractors through a system that rewards many of them not only based on actual sales, but also on their ability to recruit more distributors.

The sales tactic, popular with many nutritional supplement companies, has frequently been the target of criticism. In 1986, California authorities issued an order prohibiting Herbalife from making false claims about the weight-loss powers of its nutritional drinks.

Herbalife reported sales of $4 billion in 2012 and is sold in more than 90 countries by distributors who earn profits on product sales and additional commissions from a “multi-level marketing” compensation structure.

Ackman argues that this is a pyramid scheme that particularly disadvantages Hispanic distributors and customers.  Other hedge funds disagree and have placed “long” bets on Herbalife.

This is food politics at a breathtaking level of income.  The Times story is well worth a look.

I love this new graphic from the Council for Responsible Nutrition, the trade association for the dietary supplement industry.

My favorite: “Supplement consumers are more likely to engage in other healthy habits than non-consumers.”

This is delightfully ambiguous.  Does it mean: Supplements make consumers healthier?

Or does it mean: consumers who are healthy to begin with are the ones who take supplements?

I vote for the latter.  That’s why the great majority of studies of supplements and health show no effect.  Study subjects are already healthy and don’t need them.

By an act of Congress, dietary supplements are regulated less strictly than conventional foods, so much so that some beverage manufacturers would much prefer to have their products labeled as dietary supplements than foods, energy shots, for example.

Under the law, the FDA pretty much has to keep hands off of supplements, except when something egregious happens, like people getting sick or dying.

The FDA is now trying to clarify the difference between beverages that are supplements and those that are drugs.  It just issued:

• Industry Guidance on Distinguishing Liquid Dietary Supplements from Beverages
• Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
• Federal Register Notice for the Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
• Federal Register Notice for the Industry Guidance on Distinguishing Liquid Dietary Supplements from Beverages

These documents, however, are guidance.  The are not regulations:

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Why is FDA doing this?  I’m guessing for two reasons.

1.  The weird ingredients in energy drinks:

We have observed an increase in the marketing of liquid products with a wide array of ingredients and intended uses.  Some of these products are marketed as dietary supplements, and others as conventional foods. 

We have seen a growth in the marketplace of beverages and other conventional foods that contain novel substances, such as added botanical ingredients or their extracts.  Some of these substances have not previously been used in conventional foods and may be unapproved food additives.

2.  The high caffeine levels in those drinks.

Other substances that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels, or in new beverages or other conventional foods.  This trend raises questions regarding whether these new uses are unapproved food additive uses.

Caffeine is GRAS (generally recognized as safe) at the levels added to soft drinks.

But the levels in energy drinks are so much higher that the FDA has questions about whether GRAS applies to them.

These guidance documents are open for comment.  If you care about such issues, weigh in now.

Over the weekend, the New York Times carried a front-page story about liver damage caused by an herbal supplement advertised as a “fat burner.”

It pointed out that as a result of a 1994 act of Congress, such products are virtually unregulated.  No federal agency pays much attention to their contents or claims, and Congress only lets the FDA take action against them after they are found to be harmful.

Fortunately, vitamin and mineral supplements rarely cause harm.  But the question of whether they do any good continues to trouble researchers.   As NutraIngredients_USA summarizes the latest rounds of research,

Stop wasting money on supplements, say physicians. Stop trying to position supplements as cures for disease, say industry groups.  An editorial panel of medical doctors (MDs) says the case is now closed for multivitamins: they don’t help well-nourished adults. But leading trade associations have defended the safety and efficacy of the products, calling the editorial, ‘close-minded, ‘one-sided’ and ‘overblown.’

The article refers to studies published in a recent issue of the Annals of Internal Medicine.  These showed that multivitamin supplements did nothing to prevent heart attacks or cancer, or improve cognitive function.

• Oral High-Dose Multivitamins and Minerals After Myocardial Infarction:A Randomized Trial
• Long-Term Multivitamin Supplementation and Cognitive Function in Men: A Randomized Trial
• Vitamin and Mineral Supplements in the Primary Prevention of Cardiovascular Disease and Cancer: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force

This led to an editorial entitled:

• Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements

Its conclusion: Most multivitamin supplements do no good; some may do harm.  If you are healthy, you don’t need them.

Not that this will stop anyone from taking them….