Currently browsing posts about: Supplements

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….

It’s not a good time for the makers of herbal and vitamin supplements.  The better the research, the fewer benefits it shows.

Herbal supplements

DNA testing is demonstrating what many of us have long suspected: herbal supplements are not necessarily what they say they are.

As the New York Times reports, a recent study shows that many products purporting to be herbal supplements, actually contain rice, corn, or wheat (gluten-sensitive folks beware):

I would feel sorry for supplement manufacturers, if they hadn’t brought this on themselves.

First, they lobbied to get Congress to pass the Dietary Supplement Health and Education Act of 1994 (DSHEA).  This lets them advertise the benefits of supplements without much in the way of scientific substantiation.  It also excused the FDA from doing much regulation.

But DSHEA also required research.  Oops.   Although the point of asking for research was to demonstrate the benefits of supplements, things haven’t worked out that way.  Most of the research shows no benefit and, sometimes, harm.

And investigations like this one show what many have long suspected.  Without federal oversight, some supplement manufacturers will do whatever they can get away with.

Fortunately, rice substituted for St. John’s Wort is harmless and hardly matters, since St. John’s Wort doesn’t seem to do much anyway.

Vitamin Supplements

The latest review of the benefits—or lack thereof—of vitamin supplements for prevention of heart disease or cancer comes to cautious conclusions.

Limited evidence supports any benefit from vitamin and mineral supplementation for the prevention of cancer or CVD. Two trials found a small, borderline-significant benefit from multivitamin supplements on cancer in men only and no effect on CVD.

Borderline significance?  Not impressive.

The Natural Products Association, which represents supplement makers, issued a response:

• Multivitamin supplements should not be expected, without the combination of a healthy lifestyle, to prevent chronic disease.
• Dietary supplements are used by more than 150 million Americans on a daily basis. Research has shown that when taken in combination with other healthy lifestyle practices, such as consuming a wholesome diet and exercising regularly, people can benefit from dietary supplements.

Translation: if you consume a wholesome diet and exercise regularly, you really don’t need supplements.  And if you are not doing those things, supplements won’t do any good.

As for the 150 million Americans who take supplements: the ones I know tell me that they don’t care what the science says; they feel better when they take the pills.

Let’s hear it for placebo effects!

The FDA has sent a warning letter to a supplement manufacturer, Europharma, to cease and desist making health claims for several of its products.  The company, says the FDA, is promoting these products

for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act…because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

What’s interesting about this is that the focus is on what the articles say, not what is stated on the website.  This is a new approach for FDA and it will be interesting to see if it works.

According to FoodNavigator.com, Europharma is filing objections, is not admitting wrongdoing, but has removed links to the offending literature from its website.

Progress?

The bad news about dietary supplements pours in.  Most of them are harmless, but this industry is largely unregulated and the lack of oversight shows.

Here’s a brief summary of recent reports and an old one I’ve been saving for an occasion like this:

Some supplements do more harm than good

     A lengthy investigative report in the New York Times describes the death of a 22-year-old Army private attributed to taking a recommended dose of a workout supplement, Jack3d, bought at a GNC store on the base.

Jack3d contains a powerful stimulant called dimethylamylamine, or DMAA for short, which has similar effects as amphetamines, but claims to produce “ultra-intense muscle-gorging strength, energy, power and endurance.”

Some supplement companies don’t report problems to FDA

The Government Accountability Office (GAO), in Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products, reports a doubling of the number of adverse event complaints to the FDA since 2008.  It attributes the increase to FDA’s enforcement efforts and to lawsuits publicizing situations in which supplement firms are not reporting problems.

Some supplement companies can’t back up health claims

Last year, the Department of Health and Human Services’ Office of Inspector General (OIG) issued two reports examining health claims on immune support and weight loss supplements, both fast-growing segments of the industry.

In its first report, Structure/Function Claims Fail To Meet Federal Requirements, the OIG points to FDA’s limited enforcement authority over such claims.  As a result, supplement companies cut corners and ignore requirements for such claims.

Some supplement companies make it hard to complain

In its second report, Dietary Supplements: Companies May Be Difficult To Locate in an Emergency, OIG says that many supplements do not put information about where to file adverse event reports on their labels.   Many companies fail to register with the FDA.  And when companies do register, they neglect to provide required information.  About 20% of dietary supplement labels dd not provide telephone numbers or addresses where consumers can report adverse events.

The supplement industry brought this on itself

A year or so ago, the New York Times published a long article about the cozy relationship between Senator Orrin Hatch (Rep-Utah) and the supplement industry.

If you want to understand how the supplement industry gets away with ignoring regulations, read how “Senator Orrin G. Hatch has helped the nutritional supplement industry, and been rewarded with donations.”

He was the chief author of a federal law enacted 17 years ago that allows companies to make general health claims about their products, but exempts them from federal reviews of their safety or effectiveness before they go to market. During the Obama administration, Mr. Hatch has repeatedly intervened with his colleagues in Congress and federal regulators in Washington to fight proposed rules that industry officials consider objectionable.

When Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, it effectively deregulated the industry, allowing it to use a new category of vague health claims (“structure-function”), to use Supplement Facts labels, and to escape much in the way of oversight.

Even if we assume that most supplement manufacturers are honest about what’s in their products and what the products can and cannot do, some are not.  DSHEA gave the less honest manufacturers plenty of room to cause trouble, and so they do.

We will be seeing more such reports, no doubt.