Vitamins and Supplement Benefits

We normally think of Salmonella as affecting food, but the Centers for Disease Control and Prevention (CDC) reports that it's also being found in kratom, a plant that mimics the effects of opioids.

According to a bulletin from the CDC, a multistate Salmonella outbreak has been traced to supplements made from the plant. The outbreak, which began in October, has resulted in at least 11 people being admitted to hospitals for treatment, but no deaths have been reported.

Health researchers traced the cases to kratom when they sequenced DNA of Salmonella samples collected from patients around the country. Because the samples all had the same genetic makeup, the researchers concluded that they all came from the same source.

"At this time, CDC recommends that people not consume kratom in any form because it could be contaminated with Salmonella," the CDC advised in its bulletin.

Timely topic

Kratom has been in the news lately since its advocates view it as a way to treat pain without using highly addictive opioid drugs. In October 2016, the Drug Enforcement Administration (DEA) was poised to criminalize use of the plant, but it backed away from that position after facing Congressional opposition and a social media storm.

But Washington officialdom remains skeptical. Earlier this month, Food and Drug Administrator Scott Gottlieb warned consumers about kratom, saying an FDA analysis shows compounds in the plant act like prescription-strength opioids.

"There is no evidence to indicate that kratom is safe or effective for any medical use," Gottlieb said. "The scientific data and adverse event reports have 'clearly revealed' that compounds in kratom render it more dangerous than 'just a plant.'"

Consumer backlash

The statement sparked an immediate backlash. The American Kratom Association consumer group called the FDA’s statement an "unprecedented abuse of science to create a new computer program that is clearly garbage in, garbage out avoiding the rules of the Controlled Substances Act and making unproven claims that have been proven to be untrue."

Kratom does, in fact, have some of the same effects on the brain as opioid drugs, which is why it is used by some as a natural pain reliever. The plant, which is native to Southeast Asia, is a legal commodity and can be purchased online.

In a statement released on Tuesday, US Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb warned consumers about kratom, an herbal supplement that some believe could possibly reduce opioid withdrawal cravings.

A new analysis by scientists at the FDA shows that compounds in kratom, a Southeast Asian tree leaf, act like prescription-strength opioids. To date, the agency says kratom has been linked to 44 deaths, up from 36 reported in November.

"There is no evidence to indicate that kratom is safe or effective for any medical use," Gottlieb said. The scientific data and adverse event reports have “clearly revealed” that compounds in kratom render it more dangerous than “just a plant,” he said.

Potential risks

“It’s an opioid,” Gottlieb continued. "And it's an opioid that's associated with novel risks because of the variability in how it's being formulated, sold, and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms.”

To analyze the chemical structure of kratom’s compounds, FDA scientists used a 3-D computational model called the Public Health Assessment via Structural Evaluation (PHASE) methodology. This technology was used to detect how the brain reacts when it is exposed to kratom.

From this analysis, the researchers concluded that all of the substance’s compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives. They also found that 22 of the 25 compounds in kratom bind strongly to mu-opioid receptors, comparable to opioid drugs.

"The model shows us that kratom compounds are predicted to affect the body just like opioids," Gottlieb said. "Taken in total, the scientific evidence we've evaluated about kratom provides a clear picture of the biologic effect of this substance. Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids.”.

Regulatory hurdles

Kratom is currently legal under federal law, but FDA inspectors have been seizing and destroying shipments at international mail facilities for months.

In 2016, the Drug Enforcement Administration (DEA) announced plans to temporarily list kratom as a Schedule I controlled substance, which would put it in the same category as heroin.

But backlash from more than 50 members of the House and Senate, as well as a flood of complaints on social media, prompted the DEA to delay its decision. The agency instead called on the FDA to issue a public comment and scientific review of the plant.

The FDA has submitted its review to the DEA, which has not yet said whether it will escalate kratom’s listing from “drug of concern” to a Schedule I substance.

The American Kratom Association consumer group called the FDA’s statement an "unprecedented abuse of science to create a new computer program that is clearly garbage in, garbage out avoiding the rules of the Controlled Substances Act and making unproven claims that have been proven to be untrue."

"Our scientists will review the statement, but there are clear mistakes based on pre-existing confirmation bias on the part of the FDA," the group wrote.

Taking supplemental calcium and vitamin D may not lower the risk of bone breaks in older adults, a new study suggests.

An analysis of past studies, published recently in the Journal of the American Medical Association, found that there was not a significant difference in the risk of bone breaks or hip fractures for those who used calcium supplements, vitamin D supplements, or both, compared to those who took a placebo or no supplements at all.

Questioning supplement use

To come to their conclusions, the researchers conducted a meta-analysis of previous studies that measured vitamin D and calcium supplement use in over 51,000 older adults living in the general community.

After summarizing and reviewing the data, they found that these supplements were not associated with lower risk of new fractures, regardless of the patient’s sex, fracture history, calcium intake in their diet, baseline vitamin D concentrations, or the supplement dose they took.

While the researchers admit that the analysis did not test all participants’ baseline vitamin D concentration, they concluded that their findings “do not support the routine use of these supplements.”

However, they do point out that calcium and vitamin D supplements may still be useful for older people living in nursing homes or other residential facilities, since this population is more likely to have osteoporosis due to a combination of poor diet, less sun exposure, and other factors.

Current guidelines

Vitamin D and calcium supplements are often recommended for older adults with deteriorating bone health. The recommended daily intake of vitamin D for most adults is 600 IU (international units) or 800 IU after age 70.

Women aged 50 or younger and men 70 or younger should get 1,000 milligrams (mg) of calcium per day, according to the National Osteoporosis Foundation. That number rises to 1,200 for men and women older than that.

However, the researchers say the lack of a significant association between use of supplements containing calcium, vitamin D, or both and fracture prevention in older adults suggest these guidelines should be changed.

Alternatives

Lead researcher Jia-Guo Zhao of Tianjin Hospital in China believes that making certain dietary and lifestyle improvements may be more effective in preserving bone health than taking these supplements.

Spending time outside is one way to get more vitamin D the natural way, since sunlight is an excellent source of the nutrient. Eating fish -- especially oily or fatty fish, like salmon -- can also provide a hearty dose of vitamin D.

Seniors can also lower their risk of falls and fractures by maintaining a healthy weight and improving balance and coordination through exercise..

For a calcium boost, older adults can up their intake of calcium-rich foods like milk, cheese, yogurt, or leafy greens.

If you’re serious about working out and building muscle, then there’s a good chance that you take some sort of supplement to help your body recover and grow. But a recent study from the University of Stirling shows that one popular type of muscle-building supplement isn’t all that effective by itself.

Researchers say that branched-chain amino acids (BCAA) aren’t doing much for gym-goers when taken by themselves. Professor Kevin Tipton explains why they’re used and why they’re not optimal.

“Amino acids are the building blocks of proteins and the special class of amino acids, known as BCAA, stimulate muscle growth response,” he said. “These supplements are considered to be an important part of the nutrition plan for many bodybuilders, weightlifters and others seeking muscle growth.”

“Our results show that the common practice of taking BCAA supplements in isolation will stimulate muscle protein synthesis – the metabolic mechanism that leads to muscle growth – but the total response will not be maximal because BCAA supplements do not provide other amino acids essential for the best response.”

Bulking up

The study used a group of trained weightlifters who took part in resistance training at the gym and followed it up with BCAA supplements in a dose equivalent to 20 grams of whey protein.

The researchers found that the BCAA supplement slightly enhanced participants’ muscle growth response when compared to a placebo. However, the muscle response more than doubled when participants took a whey protein supplement that contained equivalent amounts of BCAA and other essential amino acids.

Tipton says that those other amino acids are key to muscle growth, and it is the reason why BCAA supplements by themselves don’t deliver as much value.

“A sufficient amount of the full complement of amino acids is necessary for maximum muscle building, following exercise. Athletes interested in enhancing muscle growth with training should not rely on these BCAA supplements alone,” he said.

The full study has been published in Frontiers of Physiology.

In a previous study, researchers from the University of Southern Denmark Faculty of Health Sciences found that taking vitamin D supplements during pregnancy reduced the risk that a child would develop ADHD by the time they reached 2 ½ years old.

While the study did not prove that low vitamin D levels were a cause of ADHD, the team noted that “there is a link that we cannot explain in any other way,” and that more research was necessary. While the jury is still out when it comes to ADHD, researchers from the University of Surrey and University of Bristol have now linked insufficient levels of vitamin D in pregnancy to other detriments in child development.

"The importance of vitamin D sufficiency should not be underestimated. It is well-known to be good for our musculoskeletal systems, but our research shows that if levels are low in expectant mothers, it can affect the development of their children in their early years of life,” said lead author Andrea Darling.

Social and motor development

After examining data on over 7,000 mother-child pairs, the researchers found that pregnant women who were deficient in vitamin D (less than 50 nmol per liter in blood) were more likely to bear children who later scored in the bottom 25% in pre-school development tests for gross and fine motor skills at 2 ½ years old.

The researchers say that assessments for motor skill development included tests for coordination -- such as kicking a ball, balancing, and jumping -- and the usage of fine muscles, like the ability to hold a pencil or build a tower with bricks.

Additionally, these same children scored poorly when assessed for social development skills at 3 ½ years old when compared to children born to mothers with sufficient vitamin D intake. Vitamin D deficiency was not linked to IQ or reading ability at older ages, though.

Minority groups at risk

The researchers point out that certain minority groups are especially at risk when it comes to vitamin D deficiency. However, they note that it is important for expectant mothers to walk a fine line when it comes to taking supplements because too much can also be harmful.

"Many pregnant women, especially those from minority groups with darker skin (e.g. African, African-Caribbean or South Asian), will still need to take a 10 micrograms vitamin D supplement daily, particularly in the autumn and winter when vitamin D cannot be made from the sun in the UK," said Darling. “However, it is important to remember that 'more is not necessarily better' and it is important not to take too much vitamin D from supplements as it can be toxic in very high doses."

If taking vitamin D supplements is not for you, the researchers say that there are a number of dietary options that contain healthy levels of vitamin D that can promote child development. These include oily fish like salmon, sardines, mackerel, and fresh tuna; small amounts of red meat, eggs, and fortified fat spreads; and certain breakfast cereals.

Consumers are reminded to always check with a primary care physician or specialist before taking any supplement or changing their diet.

The full study has been published in the British Journal of Nutrition.

It’s summertime, and for many consumers that means plenty of time outside around the grill, hiking favorite trails, or sprawled out on the beach. Unfortunately, it might also mean some pretty nasty sunburn if you forget to apply sunscreen.

While properly protecting yourself from the sun’s harmful rays is always the preferred option, a recent study from the Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center shows that taking a healthy dose of vitamin D immediately after getting sunburn can help alleviate skin redness, swelling, and inflammation.

“We hypothesize that vitamin D helps promote protective barriers in the skin by rapidly reducing inflammation,” said senior author Dr Kurt Lu. “What we did not expect was that at a certain dose, vitamin D not only was capable of suppressing inflammation, it was also activating skin repair genes.”

Alleviating symptoms

The double-blind, placebo-controlled study used 20 participants who were randomly given either a placebo pill or 50,000, 100,000, or 200,000 IU of vitamin D one hour after receiving a small UV lamp “sunburn” on their inner arm. Patients were assessed 24, 48, and 72 hours after taking their pill, and then one week later researchers collected skin biopsies for further testing.

The results showed that patients who were given the highest dose of vitamin D had the greatest outcomes, with less skin inflammation 48 hours after receiving the sunburn. These patients also had less skin redness and showed a jump in gene activity related to skin barrier repair when compared to other patients.

The biopsies that were collected also revealed a potential mechanism behind skin repair. The researchers found that vitamin D increased the amount of an anti-inflammatory enzyme called arginase-1, which enhances tissue repair after damage and helps activate other anti-inflammatory enzymes. Lu and his colleagues say their trial is the first to describe the anti-inflammatory benefits of taking vitamin D.

Not so fast...

While the results of the study look promising, the researchers caution that consumers shouldn’t start ingesting large amounts of vitamin D as a cure for sunburn. Currently, the U.S. Food and Drug Administration (FDA) only allows for 400 IU of vitamin D intake for adults.

“I would not recommend at this moment that people start taking vitamin D after sunburn based on this study alone. But, the results are promising and worthy of further study,” said Lu.

The full study has been published in the Journal of Investigative Dermatology.

Foods and supplements that are rich in probiotics are becoming increasingly popular, so much so that some companies have even started making probiotic supplements for children. But are all these products created equal?

Independent supplement tester Labdoor wanted to find out, so it tested 11 of the most popular children’s probiotic supplements to check for safety and effective bacteria. While several brands received high overall scores, the researchers say that many others had questionable effectiveness and were vague or uninformative about their bacterial make-up.

“Even though we’re used to seeing total bacterial counts on labels, researchers now advocate for displaying specific strain quantities as this determines what conditions a product is good for,” the researchers wrote in a release.

“Out of the 11 products in this analysis, however, 7 claimed proprietary blends where this information was left out. Only 2 products specifying strains had effective amounts according to pediatric guidelines developed by the World Gastroenterology Organization.”

Top brands

The leading brand according to the analysis was Pedia-Lax Probiotic Yums, which received a score of 96.6 out of a possible 100 points. It received full marks for product purity, nutritional value, and projected efficacy, and good scores in label accuracy and ingredient safety.

Garden Of Life Organic Kids+ came in at a close second with a score of 92.6. While it scored well in product purity, nutritional value, ingredient safety, and projected efficacy, a low score of 48 on label accuracy dragged down its overall score. Researchers said that the product measured 38% less viable bacteria than the label claimed.

Rounding out the top three was Hyperbiotics PRO-Kids with a score of 84.8. It received full marks for product purity and nutritional value and a good score for ingredient safety, but its projected efficacy and label accuracy scores only received scores in the 70s. Researchers said that the product measured 17% more viable bacteria than the label claimed.

The full list of products and their ratings can be found here.

Serious health implications

The researchers said that labelling inaccuracies were a major issue for many of the products that placed lower on the list, with an average deviation of 160% for claims on total bacteria. These differences hit extremes in both directions, with one product having 7 times the bacteria it claimed and another having practically no living bacteria at all.

“Even though probiotic supplements for children are taking over retail shelves, research and quality-testing are still catching up,” the researchers explain. While research has confirmed that probiotics help us digest and absorb food, we’re only just discovering how they affect metabolism, immunity, and mood, even in developing children.”

“These links have implications for a child’s risk in a number of major diseases, including diabetes, affective disorders, and autoimmune diseases like eczema.”

We sometimes take it for granted that the pills and supplements we take every day are safe, but a recent study finds that certain oral contraceptives taken by women may negatively impact quality of life.

Conducted in Sweden at Karolinska Institutet and the Stockholm School of Economics, the researchers point out that not much is known about contraceptive pills, despite their broad use on a global scale.

"Despite the fact that an estimated 100 million women around the world use contraceptive pills we know surprisingly little today about the pill's effect on women's health. The scientific base is very limited as regards the contraceptive pill's effect on quality of life and depression and there is a great need for randomised studies where it is compared with placebos," said professor Angelica Lindén Hirschberg.

Lower quality of life

To remedy that knowledge gap, the researchers analyzed 340 healthy women between the ages of 18 and 35 to see how particular oral contraceptives affected their health. The two main ingredients of the pills were etinylestradiol and levonorgestrel, which are recommended in many countries as the first choice of oral contraception because they have the least amount of risk connected to thrombosis.

Over the course of three months, participants were treated randomly with either placebos or the oral contraception pills, with neither the participants or leaders of the experiment knowing which treatment was given to which women.

At the end of the study period, the researchers found that general quality of life, mood, well-being, self-control, and energy levels were negatively affected by the contraceptive pills, although depressive symptoms were not prevalent. The researchers admit that the changes were relatively small, but they say that the findings could have important clinical implications.

"This might in some cases be a contributing cause of low compliance and irregular use of contraceptive pills. This possible degradation of quality of life should be paid attention to and taken into account in conjunction with prescribing of contraceptive pills and when choosing a method of contraception," says lead researcher Niklas Zethraeus.

The full study has been published in Fertility and Sterility.

The Food and Drug Administration (FDA) has given a green light to a new drug, Xadago (safinamide), as a supplemental treatment of Parkinson's disease.

The agency says the drug may be prescribed for patients who are now taking the drug levodopa/carbidopa and experiencing "off" episodes.

An "off" episode is a case where a patient's medication is not working well, meaning the patient is more likely to suffer Parkinson's symptoms, such as tremor and difficulty walking.

Parkinson's is a progressive disorder affecting the nervous system, which means it reduces a patient's ability to control movement. According to the Mayo Clinic, it develops gradually, often starting with a barely noticeable tremor. It can also cause stiffness and slowed movement.

Early stages of the disease may affect facial expressions and result in slurred speech. Because it's a progressive disease, symptoms will worsen over time.

'Relentless disease without a cure'

"Parkinson's is a relentless disease without a cure," said Dr. Eric Bastings, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "We are committed to helping make additional treatments for Parkinson's disease available to patients."

The FDA says Xadago was shown to be effective in treating Parkinson's in a clinical trial of 645 patients who were also taking levodopa but were having periodic worsening symptoms. The FDA found that the patients taking Xadago experienced more "on time," when their symptoms were not present or were less severe.

The FDA cites data from the National Institutes of Health showing about one million Americans have been diagnosed with Parkinson's. There are an estimated 50,000 new diagnoses each year.

Patients being treated for Parkinson's disease and who suffer from periodic worsening symptoms should discuss Xadago with their physician.

Too much sunshine isn't good for you, but neither is too little. Hoping to strike a proper balance, Spanish researchers have estimated the duration of solar radiation exposure needed to obtain the recommended doses of vitamin D.

While 10 to 20 minutes in the sun is enough in spring and summer, almost two hours would be needed in the winter months, the researchers found, concluding that it is difficult to achieve the optimal values year-round for the vast majority of the population.

Vitamin D deficiency

While it's true that too much ultraviolet radiation can contribute to cancer, aging of the skin, and other health issues, it also reduces blood pressure, synthesises vitamin D, and improves the treatment of several diseases.

Vitamin D deficiency is linked in adults to a higher risk of suffering from various diseases. Since very few foods contain this vitamin, its synthesis in the skin as a result of sun exposure is the main natural source that exists.

So researchers at the Solar Radiation Research Group at the Polytechnic University of Valencia (UPV) set out to find the exposure time needed to obtain the recommended doses of vitamin D without damaging our health. 

"In Spain, despite being a country with many hours of sunlight, several articles have reported a high percentage of vitamin D deficiency among various strata of the Spanish population," said María Antonia Serrano, a scientist at the UPV and main author of the study.

29 minutes

Serrano and her colleagues estimated the time needed to obtain the recommended doses -- which is equivalent to a daily intake of 1,000 IUs (international units) of vitamin D -- in an area such as the city of Valencia, which receives a large dose of UV radiation throughout the year.

They analyzed ultraviolet solar irradiance (UVER) around midday (between 12:30 and 1:30) for four months of the year (one in each season) from 2003 to 2010. With these figures, the time taken to cause sunburn was calculated.

They found that in July, an individual with normal skin could spend only 29 minutes in the sun without erythema, the technical name for sunburn. But in January, the time increases to more than two hours -- 150 minutes.

Maintaining vitamin D in winter

The study found that, even in sunny countries like Spain, it is difficult to attain recommended doses of vitamin D in winter because of the excessive time required.

On the other hand, in the middle hours of the day in spring and summer, with 25% of the body exposed, around 10 minutes of sun exposure in early afternoon would be sufficient to meet daily vitamin D requirements.

"Radiation received also depends on posture, body shape, and clothing. It should also be remembered that not all areas of the body synthesise vitamin D with the same efficiency," Serrano noted.

An individual's age also plays an important role in synthesising vitamin D from UV radiation, because the older one gets the less able one becomes to produce vitamin D: middle-aged adults have 66% of the potential children have to do this.

"These results can help to adopt the right measures to make up for any deficiency, such as informing the medical profession about the utility of increasing vitamin D intake in the diet or through supplements," the Spanish researcher concludes

The results have been published in the journal Science of the Total Environment.

Millions of Americans take dietary supplements for a variety of reasons. While there is considerable debate about the usefulness of these products, consumers should always be sure the supplement they are taking is safe.

In California, a federal judge has ordered VivaCeuticals Inc., doing business as Regeneca Worldwide, to stop sellings its dietary supplement products. The Food and Drug Administration (FDA) said the products contain unsafe ingredients, including something called 1, 3-dimethylamylamine (DMAA).

Among the charges leveled by the FDA is that the products amounted to unapproved new drugs, as well as adulterated and misbranded dietary supplements.

Claims consumers were deceived

"Consumers have a right to expect safe dietary supplements," said Melinda Plaisier, the FDA's associate commissioner for regulatory affairs. "When a company continues to defraud and deceive consumers, risking public health, we will take action to protect the American public."

The ingredient DMAA has a history among athletes and body-builders. It is an amphetamine derivative that in the past was promoted as a natural stimulant.

DMAA showed up in body-building aids, performance boosters and weight control products. At one time DMAA was an approved drug for nasal decongestion, but that use has been withdrawn and today there is no approved medical use for DMAA.

The drug has the effect of narrowing blood vessels and arteries, which can raise blood pressure and lead to heart problems, the FDA said.

The company has signed a consent decree with the government, blocking it from marketing new, unapproved drugs and misbranded dietary supplements.

Benefits and risks

The FDA says taking a dietary supplement can provide benefits as well as risks. But unlike drugs, the FDA is not allowed to review supplements before they hit the market. The agency can only act after consumers begin buying them.

The FDA says consumers may take a supplement if they aren't getting enough nutrients and vital substances through their diet. But you should always consult with your doctor before taking a supplement since the FDA says many of these products contain active ingredients that have strong effects on vital organs.

Those dangers include combining supplements, using supplements with medicines, and overdosing.

With some arm-twisting by the U.S. Justice Department, supplement seller GNC has agreed to stop selling any supplement or ingredient that the Food and Drug Administration has said is unsafe or illegal. GNC agreed to a similar but less extensive agreement with the New York Attorney General last year. 

It's part of a wide-ranging "non-prosecution agreement" that followed a lengthy investigation of GNC's practices by the Justice Department and FDA. It also includes a $2.25 million fine and a pledge by GNC to cooperate in government investigations and prosecutions of supplement manufacturers.

“Unlawful dietary supplements are an important enforcement priority for the department,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “Today’s resolution is a significant step forward in reforming an industry rife with alarming practices. Companies like GNC need to do more to ensure that they are not selling products containing questionable and untested ingredients."

"We are pleased to have reached an agreement with the DOJ related to certain products manufactured by USP Labs which were removed from GNC’s shelves years ago," GNC said in a statement to ConsumerAffairs. "We are pleased to have put this matter behind us and remain committed to providing our customers with the highest quality products available, using the purest and most effective ingredients, to help them live healthier lives.”

As part of the agreement, GNC admitted that it "engaged in acts and omissions" that allowed a misbranded supplement -- OxyElite Pro Advanced Formula, a product of Dallas-based USPlabs LLC (USP Labs) --to be sold at GNC locations nationwide in 2013. 

GNC sold the product based on USP Labs' claim that ingredients contained in the product complied with the law and did not make any attempt to test the products or verify USP Labs' claims.

USP Labs was indicted in November 2015 and is awaiting trial. The indictment alleges that USP Labs imported ingredients from China using false certificates of analysis and false labeling, and then lied about the source and nature of those ingredients after it put them in its products. 

GNC's obligations

The agreement obligates GNC to:

• Immediately remove from its shelves any product containing an ingredient that FDA has branded as unsafe;
• Establish a "restricted list" of ingredients that are not to be used in any dietary supplements it sells and a "positive list" of ingredients that are approved for sale;
• Require more explicit guarantees from vendors that their products don't contain ingredients on the restricted list
• Work to develop an industrywide quality seal program. 
• Once the seal is established, stop paying its salespeople bonuses for directing customers to products that don't carry the seal; and
• Strengthen its adverse event reporting policy. 

Earlier efforts

It's not the first attempt to rein in questionable practices at GNC. Last March, the company entered into a similar agreement with New York Attorney General Eric T. Schneiderman after a study by the AG's office found the majority of supplements being sold by GNC, Target, Walgreens, and Walmart did not contain the ingredients they claimed. 

Under that agreement, GNC agreed to perform DNA barcoding on the “active” plant ingredients used in its products; implement testing for contamination with allergens, both before and after production; and post prominent signage advising consumers of the processed, chemical nature of extracts.

The agreement applied to all 6,000 GNC stores and was the first nationwide requirement calling for improved testing standards for herbal supplements.

Many people -- especially older people -- take glucosamine and chondroitin supplements, hoping they may help relieve arthritis. But a new study finds they may do more than that -- the glucosamine may increase pressure in the eye in patients with glaucoma.

Glaucoma is a condition in which high pressure in the eye -- intraocular pressure [IOP] -- damages the retinal nerve. It's the most common cause of blindness and typically afflicts older people. 

In a research letter, Ryan K. Murphy, D.O., M.A., of the University of New England College of Osteopathic Medicine, Biddeford, Maine, and colleagues examined the relationship between the popular supplments and intraocular pressure, reporting their results in JAMA Ophthalmology.

 The results: glaucoma patients' intraocular pressure went up "significantly" when they started using glucosamine and decreased when they stopped. 

“Many questions are raised by glucosamine supplementation-associated IOP changes. This study shows a reversible effect of those changes, which is reassuring. However, the possibility that permanent damage can result from prolonged use of glucosamine supplementation is not eliminated,” the authors conclude.

What to do

Older consumers and anyone with a history of elevated intraocular pressure should talk to their ophthalmologist before using glucosamine supplements.

A diet supplement recommended by a doctor caused thyroid damage that nearly killed him, a Seattle-area man claims in a lawsuit. Curtis Farber says that because of the "Tri-Quench" iodide product, he will have to take thyroid supplements for the rest of his life.

Farber says Dr. Jonathan V. Wright recommended the supplement, claiming it could reverse atherosclerosis, or hardening of the arteries. Instead, Farber claims he suffered "an almost virtual shutdown of typical metabolic functioning" from taking the supplement and almost died.

Farber's suit names Wright, the Tahoma Clinic, the Scientific Botanicals Co. and Wright's wife, Courthouse News reported.  He says Wright sold the supplement for $28 a bottle. Wright's site now offers a one-ounce bottle for $45.

On its website, the Tahoma Clinic describes itself as "Seattle's Holistic Medicine and Wellness Center." It says it "emphasizes the use of natural materials and natural energies for both the prevention and treatment of all health problems not requiring surgical intervention.'

The site also includes an online store where consumers can order the supplements hawked by Wright.

Health claims

"In an effort to sell Tri-Quench, Wright promoted an article he authored in books, on blogs, and other social outlets wherein Wright promoted the use of Saturated Solution of Potassium Iodide ('SSKI') to cure a number of ailments, including atherosclerosis, COPD [congestive obstructive pulmonary disease] and acne," the suit alleges.

Wright says he now must take daily thyroid supplements to address the permanent damage caused to his thyroid by the Tri-Quench.

"Failure to take the daily medications subjects plaintiff to the risk of coma and/or brain damage," the complaint states.

FDA raids

Farber also says in the suit that he was never informed that Wright and his clinic had been "raided by the FDA."

"Curtis was not informed by the marketing machine of defendants that Wright, clinic, and dispensary had a history of raids by the Food and Drug Administration for issues relating to labeling violations, issues relating to misleading consumers, dosage inaccuracies, and prescribing FDA banned substances to consumers," the complaint states.

In May 2004, the FDA sent Scientific Botanicals a warning letter stating that it had found "serious violations" in an analysis of the firm's hydroxy folate supplement. 

"Our analysis of Hydroxy Folate revealed that the actual level of Folic Acid in the product is significantly less than the level listed on the label. The product is labeled to contain 400 mcg or 100% of the Reference Daily Intake per two drops. However, FDA analysis found that it contained less than 55% of the amount declared on the label," the FDA said.

In a response, the company said it had suspended sales of some products and revised the labels on others to satisfy the FDA's objections. 

Amway, the controversial multi-level marketing company, is facing the prospect of a class action lawsuit over its Nutrilite line of liquid dietary supplements.

Labels for Nutrilite’s “fruits & vegetables 2GO Twist Tubes” claim in big print that the product represents two servings of fruits and vegetables. The fine print clarifies that a dose “contains the antioxidant equivalent of 2 servings.”

Either way, the nonprofit Center for Science in the Public Interest says that the company’s 10-milliliter tubes do not come close to conveying the same health benefits as real fruit or vegetables.

Similarly, Amway claims that Nutrilite’s Immunity Twist Tubes are an “immune system booster” that will “protect your cells.” (The Strawberry Kiwi flavor has neither strawberry nor kiwi, despite the attractive pictures of those fruits on the box, CSPI said.) The immunity claim is unlawful, according to CSPI, because it implies the product will prevent disease. It won’t, says the group.

The watchdog group warns it will sue the Ada, Michigan-based company unless it stops advertising unsubstantiated nutrition and health benefits in connection with “fruits and vegetables 2GO” and “Immunity” Twist Tubes.

Also, it said both product lines contain the artificial sweetener sucralose, despite a print advertisement for “fruits & vegetables 2GO” that claims the product has no artificial ingredients. Twist Tubes are meant to be diluted in 16 ounces of water before consuming.

"Horrible message"

“Amway is sending a horrible health message to American consumers when it holds out its Twist Tubes as a short cut to getting the health benefits of real food,” said CSPI staff litigator Seema Rattan. “People who want the health benefits of two servings of fruits and vegetables are far better off eating two servings of fruits and vegetables. And no one should be deceived into thinking that these pricey little tubes will prevent them from getting sick.”

A 20-dose pack of Nutrilite “fruits & vegetables 2GO Twist Tubes” costs $19.99 plus $7.95 shipping and handling if purchased at amway.com; Immunity Twist Tubes cost $12.35 plus $7.95 shipping and handling. Otherwise, the products are not available in stores but are sold by Amway distributors.

“Fruits & vegetables 2GO” has “the antioxidant equivalent of two of the 9–13 daily servings of fruits and vegetables your body needs,” according to Amway. But there’s far more to fruits and vegetables than just antioxidants, according to CSPI. Neither “fruits & vegetables 2GO” nor Immunity Twist Tubes has any fiber, for instance.

Real fruits and vegetables have up to 8,000 phytochemicals that may provide health benefits—something that supplements simply cannot mimic, according to CSPI. Vitamins, like the A, B, and C vitamins in Twist Tubes, account for only a small fraction of the antioxidant activity in whole fruits and vegetables. While the Immunity Twist Tube contains 1,000 mg of vitamin C, human tissues are generally saturated with vitamin C at 400 mg per day, and any excess is typically excreted.

In a letter to Amway Chairman Steve Van Andel, CSPI says that Amway’s labeling and advertising for Nutrilite products violates federal regulations and consumer protection laws in the District of Columbia, Massachusetts, Texas, New Jersey, and California.

CSPI’s litigation unit has successfully prompted several major food companies, including Quaker, Frito-Lay, Procter & Gamble, Tropicana, and Pinnacle Foods, to halt a variety of misleading labeling or marketing practices. In 2008, CSPI joined litigation that returned approximately $12 million in refunds to consumers who purchased the dietary supplement Airborne; labels and ads falsely claimed the product would cure and prevent colds.