Showing posts with label dietary supplements. Show all posts
Showing posts with label dietary supplements. Show all posts

Friday, December 15, 2017

The F.D.A. Cracks Down on Fake Opioid Addiction Treatments

Once again, the largely unregulated dietary supplements industry earns itself another black eye. The latest scam is products that purport to ease the symptoms of opioid withdrawal. Who stoops so low as to prey on victims of opioid addiction?

Case in point; a product called Opiate Detox Pro. The company's website claims that its ingredients ease opioid withdrawal symptoms, despite the fact that the company cites no research to back up its claim and has no intention of ever conducting any research. The company says that if the product doesn't work, the user can get his/her money back. Big deal!

The F.D.A. shouldn't have to keep ferreting these guys out and cracking down on them, but such is the current lack of effective regulation of dietary supplements in general. Anyone is free to market dietary supplements, as long as they don't claim to treat a specific medical condition.

With any dietary supplement, its buyer beware.

Friday, April 28, 2017

Are Vitamin D Supplements Effective in Preventing Disease?

Are you one of the millions of people who are taking vitamin D supplements? People take vitamin D supplements to prevent depression, muscle weakness, cancer, heart disease, and who knows what else. And yet, there is a lack of evidence that vitamin D supplements will prevent any of these conditions.

The trend to test for and treat alleged vitamin D deficiencies took off in 2011 with the publication of a book entitled The Vitamin D Solution - A 3-Step Strategy to Cure Our Most Common Health Problems. The suggestion by the book's author that vitamin D levels of 21-29 ng/ml are insufficient for good health were a bit of a shocker, since blood levels of vitamin D of greater than 20 ng/ml are considered normal.  The book and several studies that seemed to support its thesis led to an increase in vitamin D screening blood tests, and to recommendations by many physicians that their patients consider taking vitamin D supplements.

However, the Institute of Medicine says that there is no evidence that people who have vitamin D levels above 20 ng/ml (i.e. normal vitamin D levels) will benefit from taking additional vitamin D.  In addition, two studies published this year show that vitamin D supplements don't prevent heart attacks and don't protect women against cancer. An ambitious 5-year study is now underway to try to determine once and for all whether vitamin D supplements are of any use in preventing cancer, heart disease, and stroke.

I don't know about you, but I'm taking vitamin D deficiency off my list of things to worry about, at least for now.

Friday, January 13, 2017

Does Prevagen Improve Memory?

You've seen the commercials for Prevagen, right? It's a dietary supplement containing a protein derived from jellyfish that (according to the manufacturer) "improves memory and reduces common cognitive problems associated with aging." Trouble is, those claims are bogus, according to both the Federal Trade Commission (FTC) and the New York Attorney General's office. This week the two agencies sued Prevagen's manufacturer, Quincy Bioscience for making false and misleading claims, most notably the claim that Prevagen has been "clinically proven" to work. According to the complaint, the experiments undertaken to prove Prevagen's effectiveness were scientifically invalid because they did not show that Prevagen worked any better than a placebo.

No big deal, you say? Well, if you give people memory tests over time, you'd expect some improvement just from test familiarity alone. That's why it's so important to compare the experimental (Prevagen) group to a control group (a group given a fake pill, or placebo), using valid statistical methods.

Prevagen can cost upwards of $60 for a 30-pill bottle. According to the FTC, about $165 million a year is spent on the supplement. That's a lot for an untested cure.

Quincy Bioscience has responded to the lawsuit with a statement that says, in part, that Prevagen hasn't been shown to harm anyone (which is beside the point), and that "hundreds of thousands" of people tell them that Prevagen works and improves their lives. The latter statement, of course, is unscientific and unverifiable.

Friday, June 17, 2016

If You're Healthy, You Don't Need Probiotics

The National Institutes of Health (NIH) defines probiotics as live bacteria that are "similar to beneficial organisms found in the gut." They're found in yogurt, fermented milk, soy products and some juices, as well as (these days) in probiotic capsules, pills, and powders. Many people make sure to get plenty of probiotics in the belief that a healthier population of gut bacteria makes for a healthier individual. It's a trend strongly encouraged by the rapidly growing probiotics dietary supplements industry.

The idea that probiotics may be good for you comes from the reports that patients with certain gastrointestinal conditions can benefit from taking probiotics. For example, patients with ulcerative colitis or who have diarrhea due either to antibiotics or to a particularly bad gut bacterium called Clostridium difficile may benefit from taking probiotics to more quickly restore their gut microbiota to normal.

What if you're healthy and just want to stay that way - should you spend your hard-earned money on probiotics? The answer, according to the latest research, is "no". The authors of the research reviewed the findings of seven studies that specifically identified the composition of gut bacteria in healthy people, before and after they took probiotics. They report that in healthy people, probiotics had essentially no effect on the final composition (in terms of both variety and number) of gut bacteria. In other words, healthy people develop and maintain a healthy steady-state population of gut bacteria naturally, on their own. Taking probiotics is only likely to be helpful when the gut's normal microbiota have been severely disrupted by antibiotics or disease.

Probiotics probably won't do you any harm, mind you; it's just that if you're healthy, they're unnecessary.

Monday, October 27, 2014

Recalled Dietary Supplements Return to the Shelves

Unlike pharmaceutical drugs, dietary supplements do not have to be proven safe and effective before they can be sold. All the FDA can do is to force specific products to be pulled from store shelves (recalled) after it receives complaints about the product's safety.

A study published in JAMA shows how ineffective the FDA's recall power really is. The authors of the study examined 27 dietary supplement products that had been recalled by the FDA. Some of the products were recalled for containing anabolic steroids or prescription drugs such as Viagra and Prozac. Several weight-loss products contained an amphetamine-like drug not approved in the U.S. The authors found that within an average of three years after recall, approximately 2/3 of the products were being sold again - under the same name and with the same ingredients. Even the manufacturers and distributors were the same! Most of the manufacturers are U.S.-based.

Why can't the FDA put a stop to this? In part, their hands are tied because dietary supplement manufacturers have the right to sell their products without any proof that they are safe and effective. Tainted products are only identified after they have hit store shelves and after complaints are received. And even then, recall can be difficult because many of these products are sold over the internet from unknown physical addresses.

Until the dietary supplements regulatory environment changes and the FDA is given more power to punish unscrupulous companies, it remains "buyer beware" when it comes to dietary supplements. Unfortunately for us, the authors did not name the manufacturers, distributors, or products in their study. That's a shame.

Wednesday, April 30, 2014

Powdered Alcohol? Not Quite Yet…

You’ve all heard the joke about powdered water (“Just add water and stir”). But did you know that someone has actually managed to create a powdered alcohol product? It’s called Palcohol. Just add it to water and presto, you have an alcoholic beverage.

Last week it was reported that the U.S. Alcohol and Tobacco Tax and Trade Bureau had approved Palcohol. In truth, the bureau’s only role is to approve the packaging and labeling of alcoholic products. The choice of whether or not to allow the sale of alcoholic products is up to the individual states. After the story broke and people began expressing their opinions about the product, the bureau said that its approval of the product packaging had been “issued in error”. Final packaging approval is on hold for now. And whether any states will eventually approve Palcohol for sale is anybody’s guess.

Folks have come up with all sorts of imaginative ideas (both and good and bad) for how powdered alcohol could be used or abused. Not everyone is convinced that this product should ever reach store shelves. What do you think? Would you use it, and if so, how?

Monday, April 21, 2014

Problems with Herbal Supplements

A study by Canadian researchers provides the best evidence yet that many herbal supplement products may not be what they seem.

Using DNA analysis, the researchers first developed a DNA “barcode” library of over 100 different species of plants commonly used in herbal remedies. Then they compared the DNA barcodes of the herbal plant ingredients in 44 different herbal supplement products from 12 manufacturers against the barcode library. All of the tested products are currently available in the U.S. and Canada.

The results were, in a word, shocking. Only about half of the supplement products tested were “authentic”, meaning that the plant species listed on the product label was present in the product. However, that did not mean that the product was pure; a third of these authentic products contained contaminants and/or fillers such as rice, wheat or alfalfa. Of the 44 products tested, fully a third were complete fakes; they contained none of the herb listed on the label.

How about the quality of the different supplement manufacturers? The number of samples tested was small (only 44 products tested from 12 companies) so statistical analysis isn’t possible. Nevertheless, the researchers report that only two companies’ products were all authentic and free of contaminants or fillers. At the other end of the scale, the tested products of three companies were all complete fakes. The researchers did not provide the names of the companies, but wouldn’t we like to know?!

It’s “buyer’s beware” when it comes to herbal supplements. Take them at your own risk.

Thursday, May 16, 2013

Products Containing DMAA are Still Available

General Nutrition Centers (GNC) is still selling dietary supplement products containing dimethylamylamine (DMAA), a full month after the FDA issued a health warning about the drug. DMAA is an amphetamine-like stimulant found in the workout-boosting product Jack3d.

The FDA says there have been over 80 reports of adverse health effects associated with DMAA, and urges consumers to stop using it. In addition, the FDA argues that DMAA does not qualify as a dietary supplement according to the accepted definition of a dietary supplement. The FDA has already convinced the product’s manufacturers to stop making these products. But the retailer GNC says it does not believe that DMAA is unsafe, and so it continues to sell its stock of workout products containing DMAA.

Whether DMAA qualifies as a dietary supplement may have to be decided in court, if GNC continues to push the issue. Even so, it’s unusual for a company to refuse to take a product off its shelves when it’s labeled unsafe by the FDA. Most companies would err on the side of caution by removing of the product from store shelves immediately. A company that continues to sell a product considered dangerous by the FDA would be risking future lawsuits. Indeed, there’s already one lawsuit against GNC for a death allegedly related to Jack3D.

What is GMC’s logic in continuing to sell Jack3d?!

Monday, April 15, 2013

Workout Supplement Ingredient Banned

The Food and Drug Administration (FDA) issued a warning last week that several workout-booster and fat-burning products should be pulled from the market immediately because they contain an ingredient called DMAA (dimethylamylamine). The products, Jack3D (pronounced Jacked) and OxyElite Pro, are both marketed by USPlabs.

Back in 2011 the FDA sent letters to all 10 marketers of DMAA products, asking them to voluntarily stop marketing such products. All but USPlabs complied. The company continues to claim that the products are safe and legal.

According to the FDA, there have been 86 reports of health problems, including 5 deaths, among persons taking products containing DMAA. That does not prove that DMAA is dangerous, of course, and its not even the primary reason the FDA is asking that the products be removed from shelves. The FDA simply argues that DMAA does not fit the legal definition of a dietary supplement, and therefore it cannot be sold without prior FDA approval. I would agree; it's a drug. DMAA was actually developed by a pharmaceutical company in the 1940s and sold as a nasal decongestant until the 1980s. It stretches credulity a bit to suggest that it is a natural “supplement to the diet” when added to a workout-boosting product.

Saturday, October 27, 2012

Health Concerns Over Energy Drinks

The death of five teenagers since 2009 following the consumption of high-energy drinks has renewed calls for the FDA to do something about regulating these products. At the moment, the makers of energy drinks are not required to disclose how much caffeine their products contain, because they are marketed as beverages or dietary supplements, not drugs. But as the sales of such products have soared (doubling since 2006), so too have emergency room visits linked to energy drinks –over 13,000 in 2009 (the last year for which data are available), according to the federal Substance Abuse and Mental Health Services Administration.

Canada is ahead of the game when it comes to regulation of energy drinks, compared to the U.S. Under new Canadian rules, energy drinks will be limited to 180 mg of caffeine per can. That’s less than is in some of the most popular energy drinks, such as the 24-oz. can of Monster Energy and the 20-oz Red Bull. The American Beverage Association, which represents some of the energy drink companies in the U.S., has said it will resist the establishment of caffeine limits in the U.S.

How much caffeine can be packed into commercially-available caffeine products? A 3-tablespoon squeeze bottle of MiO liquid “water enhancer”, sold by Kraft Foods, contains over 1,000 mg of caffeine – roughly equivalent to 8-10 cups of coffee.

For more on this subject, go to a previous blog post titled "Alcohol and Caffeine - A Potent Mix."

Thursday, May 26, 2011

Melatonin in Brownies

Melatonin, a hormone and over-the-counter dietary supplement that supposedly promotes sleep and was once popular as a cure for jet lag, is now being sold in baked goods as an all-natural antidote to stress and sleep deprivation. But there’s a catch; since melatonin has not been approved as a food additive, the entire baked good containing melatonin has to be marketed as a “dietary supplement”. Indeed, the makers actually label them (in small print) “not for food use”.

Really? Products with names like Mary J’s relaxation brownies and Lulla Pies are not meant as food? Calling them dietary supplements is just an obvious way around the legal requirement that food additives must be approved by the Food and Drug Administration (FDA).

The FDA may not allow the sale of these products to continue in the long run, but the fact is that it generally takes a long time for the FDA to act. In the meantime you can buy these products at your local store. Just don’t plan on driving or operating heavy machinery after eating (uh, taking) this “dietary supplement”.

Sunday, November 7, 2010

Alcohol and Caffeine - a Potent Mix

Last year the Food and Drug Administration sent warning letters to 27 manufacturers of alcoholic beverages containing caffeine (see this blog Nov. 15, 2009), asking the companies to justify the safety of their products. But apparently the agency has not yet followed through with its promises to review the safety information requested from the companies and then to take appropriate action if it was not forthcoming.

One of the companies selling caffeine-and-alcohol drinks was in the news again last month after students at two universities ended up in emergency rooms with alcohol poisoning. The drinks in question, called Four Loko, contain 23.5 ounces of 12% alcohol laced with caffeine. Allegedly the caffeine overrides the natural sleepiness effect of alcohol, causing the user to underestimate how drunk he/she really is.

The company says that it is being unfairly singled out.

Some college students will abuse alcohol no matter what form it is in. But are packaged caffeine-and-alcohol drinks GRAS (Generally Recognized As Safe) or not? It should be up to the FDA to decide, and so far it hasn’t.

Meanwhile, states and municipalities are taking action. Last Thursday Michigan became the first state to ban alcohol-and-caffeine drinks. The city of Chicago is considering a similar ban.

For more on this subject, go to a previous blog post titled "Caffeinated Alcoholic Beverages Under Scrutiny."

Wednesday, October 6, 2010

Popular Joint Pain Supplements Don't Work

The popular joint-pain supplements glucosamine and chondroitin are ineffective in reducing knee or hip pain due to osteoarthritis, according to a recent report in the British Medical Journal. The latest meta-analysis reviewed 10 previous large, randomized, controlled studies. The authors conclude that the two supplements have no effect on either patient perception of joint pain or minimum width of joint space (a clinical measure of improvement) when compared to a placebo.

Glucosamine and chondroitin are among the most popular over-the-counter supplements, with annual sales of nearly $2 billion per year. Some people swear by the two supplements because they genuinely do feel better when taking them, and I sincerely believe they’re telling the truth. But the improvements could be due to the well-known placebo effect, or to the fact that in some patients, joint pain declines over time due to natural healing processes. Anecdotal evidence can’t be generalized to a larger population.

The authors of the study see no harm in patients continuing to take the supplements if it makes them feel better. They say that neither supplement does any harm (except to lighten your wallet a little).

Thursday, August 5, 2010

Dietary Supplements Deceptive Sales Practices

Dietary supplements are regulated as food products, not as drugs. Manufacturers are free to make vague claims of effectiveness, such as “improves heart health” or “boosts brain function”, but they cannot make medical claims such as “lowers high blood pressure” or “prevents Alzheimer’s”. And although their products are supposed to be safe, they’re not required to submit any data to prove it.

Now a Senate document reveals that even though the products may be labelled correctly, in sales conversations (“off-label”, so to speak) retail sales representatives of dietary supplements products are openly engaging in “deceptive and questionable sales tactics” – in other words, they’re lying to make a sale.

In testimony before a U.S. Senate committee, the General Accounting Office (GAO) reported that it had staff members ask questions of sales representatives such as: Is ginkgo biloba safe to take with aspirin? Can ginseng cure cancer? Is it okay to replace my blood pressure medication with garlic supplements? All too often they got “yes” answers when the correct answers are “no”. These answers are not just harmless sales advice – they are potentially dangerous advice and they are against the law. Action may be taken against some sellers as a result of the investigation. But for all practical purposes, it’s still “buyer beware” when it comes to the safety and efficacy of dietary supplements.

You can hear clips of some of the undercover calls at http://www.gao.gov/products/GAO-10-662T.

Monday, March 15, 2010

Caffeine Made Easy

Remember Sweet’n Low, the first really convenient sugar substitute? Well, now somebody has finally come up with a similar easy-to-use product containing caffeine. Fein energy crystals (pronounced FEEN) are being promoted as an energy-boosting product that can be added to any drink, including water. Fein has no calories, no artificial ingredients, and no taste, according to the company marketing it. Drop a single stick of FEIN into your drink of choice and you’re getting 75 mg of pure crystalline caffeine, roughly the amount of caffeine in some energy drinks. And Fein costs less than 70 cents per stick. You probably won’t find it in stores yet, but it’s available over the internet.

Henceforth, getting that caffeine buzz (if that’s important to you) will be as easy as sweetening your tea. This is not an endorsement; just a fact.

Sunday, November 15, 2009

Caffeinated Alcoholic Beverages Under Scrutiny

This week the Food and Drug Administration (FDA) notified 27 manufacturers of caffeinated alcoholic beverages that they must either explain to the FDA why they believe that the addition of caffeine to alcoholic beverages is “generally recognized as safe” (GRAS) or take their products off the market. According to the FDA, for caffeine to be allowed as an additive to an alcoholic beverage “there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.” If the companies cannot provide such data within 30 days, the FDA will “take appropriate action” to ensure that the products are taken off the market.

Caffeinated alcoholic beverages are marketed primarily to young people under such names as Max Vibe, Torque, and Evil Eye. Some promotional campaigns depict consumption of multiple drinks in conjunction with high-risk sports such as snowboarding and motocross biking. The action by the FDA comes after the agency received a letter from 18 state Attorneys General asking that the FDA use its authority to see that the products are removed from the market. The Attorneys General argue that caffeine can mask the effects of alcohol and could lead to increased risk-taking behavior.

The two largest manufacturers have already agreed to remove their products from the marketplace. It would not be surprising to see the others follow suit within 30 days.

Sunday, July 19, 2009

Getting That Caffeine Buzz

The latest entry into the world of marketing hype - “energy shots”, a mere two ounces of bad-tasting liquid loaded with caffeine. Manufacturers won’t say how much caffeine for proprietary reasons (and probably to add to the drinks’ mystique), but most energy shots are thought to contain on the order of 120-200 mg. That’s the equivalent of one to two ordinary cups of coffee or a 16-oz energy drink.

Energy shots may also contain B-vitamins, amino acids and various plant extracts, but these aren’t likely to give you much of an energy boost despite the products’ claims. And then there’s the cost – upwards of $3 apiece.

If it’s a caffeine buzz you need, what’s wrong with plain-old maximum strength (200 mg) No-Doz? It was your grandfather’s drug of choice nearly 50 years ago for pulling an all-nighter, and it still works. Plus it only costs about 20 cents per dose.

Thursday, November 20, 2008

Ginkgo Doesn't Prevent Dementia

According to a study in the Journal of the American Medical Association, daily doses of the popular herbal antioxidant Ginkgo biloba neither prevent nor delay the onset of dementia (cognitive impairment). The most common type of dementia is Alzheimer’s disease.

Herbal extracts of Ginkgo remain popular as a memory enhancer, even though previous scientific evidence showed that Ginkgo just doesn’t enhance memory. So don't expect this latest finding regarding dementia to put much of a dent in Ginkgo’s annual sales of over $200 million. Good marketing apparently trumps good science.

Wednesday, October 15, 2008

What's in That Energy Drink?

How much caffeine is there in those so-called “energy drinks”? Take a look at the article in press in the journal Drug and Alcohol Dependence (2008) by C.J. Reissig, et al., entitled “Caffeinated energy drinks – A growing problem”, available online at www.sciencedirect.com. According to Table 1 in the article, some of them are pretty high-powered. Most energy drinks have about the same caffeine concentration as brewed coffee, but considering that some drinks come in 16- or even 24-oz sizes, that's a lot of caffeine.

Sales of these products continue to climb. Health officials are growing increasingly concerned by reports of acute caffeine intoxication, dependence, and withdrawal among children. There is also a trend toward the combined use of energy drinks and alcohol among young adults.

Which ones do your students drink? Do they know what’s in them?

Monday, October 13, 2008

Ginkgo and Prevention of Stroke

The herbal remedy Ginkgo biloba may help prevent strokes, according to researchers at Johns Hopkins University. The researchers induced strokes in mice after treating some of the mice with various doses of Ginkgo. The mice pretreated with Ginkgo had nearly 50 percent less brain damage after stroke than the untreated mice. The researchers speculate that Ginkgo may be protective against stroke because it increases the level of an antioxidant enzyme that eliminates free radicals. And free radicals reportedly have damaging effects in living cells, even after a stroke-causing clot is removed or dissolved.

Researchers caution that so far, the research has only been done on mice. Still, it’s encouraging to see herbal remedies being subjected to the same kind of careful scientific scrutiny that has traditionally been applied to therapeutic drugs. This is exactly what we had hoped for, as discussed in Human Biology 5th ed. in the Current Issue essay entitled “Antioxidants: Hope or Hype?” (pp. 42-43). In time perhaps we’ll know the real story behind herbal remedies, and not have to rely on anecdotes and hype.