The popularity of energy drinks containing high amounts of caffeine has food and beverage producers launching all sorts of products with a jolt of caffeine—gum, jelly beans, water, and even popcorn!

Meanwhile, this trend has not escaped the attention of the Food and Drug Administration which announced that it wants to examine the cumulative impact of so many new sources of caffeine—especially since many of them are marketed to children and adolescents.

The FDA is already investigating the safety of energy drinks and energy shots following at least 150 reports of illness and 25 deaths.

Current FDA regulations governing caffeine were put in place for cola-type beverages in the 1950s and did not anticipate the proliferation of caffeine added to foods. Caffeine has the regulatory classification of "generally recognized as safe," or GRAS, which means manufacturers can add it to products and then determine on their own whether the product is safe.

Others Concerned

But it’s not just the FDA that’s noticed the influx of caffeine in the marketplace. The Center for Science in the Public Interest (CSPI) shared its concerns with the FDA last year.

"Could caffeinated macaroni and cheese or breakfast cereal be next?" asked CSPI executive director Michael F. Jacobson. "One serving of any of these foods isn't likely to harm anyone. The concern is that it will be increasingly easy to consume caffeine throughout the day, sometimes unwittingly, as companies add caffeine to candies, nuts, snacks and other foods. And that's on top of the soda, coffee, tea, and energy drinks that are already widely consumed."

The American Academy of Pediatrics has also issued a report that discourages the consumption of caffeine and other stimulant substances in the diets of children and adolescents. They warned that too much caffeine can be dangerous for children, who have less ability to process the stimulant than adults.

Large amounts of caffeine can cause rapid heartbeat, seizures anxiety, restlessness, irritability, and insomnia.

We’ll be watching what happens with this hot topic. In the meantime parents may want to keep an eye out for these amped up foods.

Sources:

NBC News

Courier Journal

Center for the Public Interest

An expert FDA panel voted 12-9 against continued marketing of the inhalable osteoporosis drug calcitonin salmon because the drug’s risks--which include a higher risk of cancer--are too great in light of little evidence that the drug prevents bone fractures.

Calcitonin salmon, marketed under the name Miacalcin and Fortical has been prescribed for osteoporosis in postmenopausal women since the 1980s.

The drug’s safety came into question after two recent studies showed a slightly higher rate of cancer (2.4%) among patients taking calcitonin pills.

When the panel weighed the risk of cancer against the fact that the drug has not shown to be very effective at preventing bone fractures, the panel voted against continued use of the drug.

Some panelists did disagree citing that for some patients who can’t take the newer bisphosphonate drugs such as Fosamax (which are not without serious side effects), calcitonin salmon is an important option. Others argued that the risk of cancer was somewhat low and more research was needed to confirm this risk.

Despite safety concerns and the introduction of newer drugs, calcitonin is still used by an estimated 205,000 women in the U.S.

The FDA originally approved the drug based on early but flawed studies showing that the drug increased bone mineral density. However, no studies have shown that higher density results in fewer bone fractures.

To address this issue of efficacy, the recent FDA panel voted 20-1 to require that any future calcitonin drugs will be required to show that they indeed help prevent bone fractures.

Source:

MedScape

A few months ago we covered the Multiple Health Problems Associated with Energy Drinks which also discusses their growing popularity among children and teenagers despite warnings from pediatricians. Since then, there have been more deaths linked to their use and an ongoing tug of war between legislators, the FDA and makers of the products.

Amid the controversy, the consumer product safety organization Consumer Reports stepped in to shed light on one critical bit of information that many manufactures don’t give consumers—the actual amount of caffeine in their products.

What They Found

Consumer Reports purchased 27 of the top-selling energy drinks from stores in three states and tested the amount of caffeine in each. (Eleven of the 27 did not list the amount of caffeine in the product on the label.)

Among those tested, here are some of the findings: (For comparison, one 8 oz. cup of coffee contains about 100 mg of caffeine.)

• The amount of caffeine per serving ranged from about 6 milligrams to 242 milligrams, but keep in mind that many bottles contained more than one serving.
• The top five containing the most caffeine were (from highest to lowest): 5-Hour Energy Extra Strength (242 mg); Rock Star Energy Shot 9229 mg); NOS High Performance Energy Drink (224 mg); Monster X-presso (221 mg).
• Among those with the lowest amounts of caffeine were: 5-Hour Energy Decaf (6 mg); FRS Healthy Energy (17 mg); Archer Farms Energy Drink Juice Infused (55 mg); Amp Energy and Bawls Guarana (71 mg).

Why the Secrecy?

If too much caffeine is the concern, then why don’t manufacturers just list the amount of caffeine in their products? There are two main reasons often cited. One is that there is no “legal or commercial business requirement” to do so, and two, manufacturers don’t want to reveal their “proprietary formulas.”

Yet the labels of more than half of those tested warn against use by children, pregnant or nursing women, and people sensitive to caffeine. Ten of the products also recommend a daily limit--which is difficult advice to follow when the amount of caffeine is not provided.

Buyer Beware

While it would be helpful for manufacturers to disclose caffeine levels, the FDA says it lacks the authority to require this. So until laws change, we are in a state of “buyer beware.”

If you can find caffeine content on the labels, here are the current daily limits: healthy adults - 400 mg; pregnant women up to 200 mg; and children, between 45 and 85 mg depending on the child’s weight.

People with certain health conditions including heart, kidney or liver problems, diabetes and mood/anxiety disorders should avoid energy drinks altogether.

Source:

Consumer Reports

According to the Natural Products Association (NPA) the latest criticism of the supplement industry in the Chicago Tribune, “offers a distorted picture of supplement safety,” said NPA Executive Director and CEO John Shaw. And being insiders ourselves, we too found many problems with the article as well:

• Using a few examples of supplement quality issues as an indictment of the entire industry is, as they say, throwing the baby out with the bathwater.
• The article perpetuates the myth that supplements are not regulated. (We addressed this myth in a prior post.) It’s important to emphasize that dietary supplements are part of a fully-regulated industry. Good manufacturing practices apply to all supplement manufacturers, large or small, and everyone in the industry must comply with them.
• Some of the examples of violations they cited were over six years old. Why alarm consumers over problems long since resolved?
• If the newspaper is truly interested in protecting the public, why not provide as we have, tips to choose the best quality supplements.

Granted, every industry will have its share of bottom dwellers that may try to cut corners to increase profits, but by and large most manufacturers like CNCA Health will not sacrifice the safety and efficacy of their products to make a buck.

While we do applaud the FDA’s efforts to root out unscrupulous manufacturers, the supplement industry does not sit idly by.  Industry groups like the NPA and many others take a proactive approach to self regulate and educate its membership on best practices. In doing so, industry standards are often higher than the minimum standards set by the FDA.

Leading dietary supplement manufacturers work hard to maintain the highest standards as we exist first and foremost to help people enjoy optimal health and wellness. Anything less would be morally offensive.

CNCA Quality Standards

At CNCA, our manufacturing process includes extensive testing for maximum purity and optimal potency. Our quality standards are unparalleled in the nutritional supplement industry, going well beyond the requirements of other certification programs and FDA regulations. We achieve the highest levels of quality by using independent analytical laboratories to extensively test raw materials and finished goods for purity, identity and potency.

For example, CNCA raw materials are independently tested for toxins and contaminants that are not required under USP and NSF certification programs. Our potency and metals testing are more precise, and our exhaustive chemicals and solvents testing greatly exceed USP and NSF standards. Finally, unlike other national standards, we screen all our botanicals for a full range of aflatoxins, agrochemicals, and solvents (more than 100 individual tests).

Because of our vigilance to quality, CNCA products are recommended by some of the country’s leading medical practitioners every day. CNCA products are used in hospitals, pharmacies, and by thousands of people across the U.S. who demand nothing less than the highest quality nutritional supplements.

We go to these extraordinary lengths to ensure that our superior quality products are consistently ultra-pure– because, in our opinion, this testing must be done in order to protect the public health. Our commitment to superior quality may make CNCA products cost a little more than the “bargain basement” brands, but if you’re as serious about your health as we are, it’s simply the right thing to do.

We encorage you to watch this five-minute video interview with Dr. Timothy Birdsall, vice chairman of CNCA's Quality Control Unit, who explains just how easy it is to find contaminated supplements and recommends which supplements everyone should consider taking.

Sources:

Chicago Tribune

Natural Products Association

After decades of research supporting the cardiovascular benefits of eating fish rich in omega-3 fatty acids, health experts recommend eating fish at least two times a week. However, eating fish isn’t without some risk due to the presence of mercury and PCBs in some fish. Currently pregnant women and children are advised by the U.S. Food and Administration (FDA) to avoid eating certain species of fish that may have the highest levels of these contaminates. For others, fish consumption has been encouraged as it was thought that the benefits of fish far outweighed the risks.

Now a new study raises concerns that we might need to reassess the risks of eating fish and take measures to reduce our exposure to mercury.

Researchers from Syracuse University found that even a slight increase in mercury from fish was associated with hormone disruption and increased markers of systemic inflammation.

The study measured fish consumption, blood lipids, total blood mercury, cortisol levels and inflammation markers in children ages 9 to 11. While children consuming fish had significantly better lipid profiles, they had higher levels of mercury in their blood. Increasing levels of mercury was significantly associated with lower cortisol levels and proteins suggestive of systemic inflammation.

Excessive inflammation over long periods has been linked to serious health conditions including autoimmune disorders, cancer and cardiovascular disease.

Study authors concluded that their results call for greater caution. “Without a better understanding of the long-term consequences of an atheroprotective lipid profile relative to blunted diurnal cortisol and systemic inflammation, a determination of the risk-benefit ratio for fish consumption by children is not possible.”

Reducing Mercury Exposure

The safest way to get the benefits of fish without the risk of mercury is a high quality fish oil supplement.

We stipulate “high quality” as there are significant differences in the quality and potency of fish oil supplements on the market. The best quality fish oil supplements are made from smaller fish that typically contain little or no mercury and PCBs to begin with. Then the oil is purified and concentrated to provide high amounts of EPA and DHA. And finally, as fish oil can spoil, a high quality fish oil supplement will contain an antioxidant to preserve freshness and prevent rancidity (spoilage).

Adults who want to continue eating fish can reduce their risk of mercury by avoiding certain species that tend to contain higher amounts of mercury:

• Shark
• King Mackerel
• Swordfish
• Tilefish

Fish that contains the least amount of mercury while still providing a good source of EPA and DHA include:

• Salmon
• Pollock
• Flounder or Sole
• Sardines
• Anchovies
• Herring

Sources:

Pub Med

New Hope 360

American Heart Association

When it comes to your health, you decide how you will support your own wellness goals. Whether it’s eating a healthy diet and exercising or doing nothing at all, it’s your choice. But what happens when misinformation and myths cloud your choices? How will this impact your health?

The American Botanical Council (ABC) is concerned that the myth that supplements are “unregulated” may cause consumers to remove supplements as an option to support their health. For over ten years the ABC has been working to dispel this myth and recently redoubled its efforts.

In 2000, they published their first report detailing the extensive legislation governing the industry and the enforcement powers of the Food and Drug Administration and Federal Trade Commission. These agencies are charged with ensuring that dietary supplements are safe and that their claims are not false and misleading.

In a renewed offensive, the ABC has published a new report, “The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled.” This new article adds new evidence to squash the still-pervasive myth of an unregulated dietary supplement industry.

The authors re-encapsulate the Dietary Supplement Health and Education Act of 1994 (DSHEA) and provide an in-depth review of important legislation amending the Federal Food, Drug, and Cosmetic Act (FDCA) passed since the publication of the first article. Such additional legislation includes the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006), the FDA Amendments Act (2007), and the FDA Food Safety Modernization Act (2011).

“It is puzzling that the myth of the unregulated dietary supplement industry has continued for so many years,” said supplement law expert Holly J. Bayne, and co-author of the ABC report. “The passage of DSHEA clearly established a comprehensive legal framework for FDA regulation of dietary supplements. FDA has all the legal authority it needs to protect public health and safety and remove unsafe or mislabeled products from the marketplace. Dietary supplements are clearly regulated by FDA, but they are regulated differently than prescription and OTC [over-the-counter] drug products.”

Another contributing author of the ABC report is Dr. R. William Soller, executive director of the Center for Consumer Self Care and professor in the School of Pharmacy at UCSF. He adds, “Any remnant of the myth that dietary supplements are an unregulated industry is easily dispelled by a close look at the agency’s activities over the past fifteen years. We trust that this article, once read, will help provide more clarity to this muddled area of significant concern….”

If you are concerned about the dietary supplement regulations in place to protect you, we invite you to read the American Botanical Council’s Report here.

In the meantime, CNCA will continue to exceed regulatory requirements to ensure that CNCA supplements meet our superior quality standards for purity, potency and authenticity.

Sources:

New Hope 360

When you’re shopping for cereal at the grocery store, you can read a list of all the ingredients in the box before making a purchase. You’ll also have the peace-of-mind in knowing that the FDA requires that every food ingredient has been tested and found to be “Generally Regarded as Safe” or GRAS.

It’s an entirely different story when it comes to household cleaning products. Manufacturers are not required to list all the ingredients on their labels, just those of “known concern.” The problem is, among the 3,000 top-selling chemicals in the United States, over 90% have no basic toxicity information and the testing required to determine safety is usually voluntary. More than likely, there are many compounds in your home that have never been tested for safety on their own, not to mention in combination with the others.

These facts make what little we do know about household chemicals all the more unsettling. The average household contains numerous toxic chemicals, say environmental experts. We’re exposed to a chemical soup—from phthalates in synthetic fragrances to the noxious fumes in oven cleaners. Ingredients in common household products have been linked to asthma, cancer, reproductive disorders, hormone disruption and neurotoxicity.

A First Step

Starting in 2010 industry groups began making more ingredient information available to consumers - but not on the product label itself. The program called, the Consumer Product Ingredient Communication Initiative covers four product categories: air fresheners, automotive care, household cleaners, and floor polishes and allows consumers to get a full list of ingredients online or on the phone.

Legislation was introduced in 2009 that would have required manufacturers of household cleaning products to list all ingredients on the product label. The legislation stalled in committee and never came up for a vote. The legislation may be reintroduced during the 2012 session.

In the meantime, many consumers have switched to “green” household cleaners or their own home-made solutions. According to a survey by the American Cleaning Institute, more than 28% of Americans say they’ve mixed their own cleaners and that they were more effective than their commercial counterparts.

Find out how to reduce your “toxic burden” and clean your home without chemicals with our guide: How to Deep Clean Your Home Naturally.

Sources:

MSNBC

Green Biz

Environmental Working Group

GovTrack

After finding arsenic and lead in fruit juice that exceeded the FDA limits for drinking water, the consumer’s advocacy organization, Consumers Union, is urging the FDA to set a more protective standard for these contaminants in fruit juice. While the FDA has set limits for arsenic and lead levels in drinking water, no limits are defined for fruit juices.

Carcinogens in Juice

In testing 88 samples of apple juice and grape juice, Consumer Reports found that 10 percent of juice samples had total arsenic levels exceeding federal drinking-water standards of 10 parts per billion (ppb), and 25 percent had lead levels higher than the 5 ppb limit for bottled water set by the Food and Drug Administration.

These tests measured “total” levels of arsenic which includes organic and inorganic arsenic. Organic arsenic is considers safe by some but the jury is still out. Most of the arsenic detected in these tests was inorganic, which is a human carcinogen.

In addition to testing juices, Consumer Reports also analyzed the Centers for Disease Control and Prevention's data on arsenic in the urine of men and women who were willing to report their food and drink consumption for 24 hours prior. Analysis showed that people who reported drinking apple or grape juice had, on average, about 20 percent higher levels of total urinary arsenic than those subjects who did not.

A Call for Lower Limits

Consumers Union is urging the FDA to set a more protective standard of 3 ppb for total arsenic and 5 ppb for lead in juice. The FDA’s current “level of concern”— the point at which they might consider taking action is 23 ppb. Consumer Reports says this level is way too high and does not consider the risks of skin, lung and bladder cancer that arsenic exposure poses to the public.

The FDA has responded saying that it is considering setting guidance for the level of inorganic arsenic permissible in apple juice. But before they do so, they want to continue collecting and analyzing up to 90 samples of apple juice from retailers across the U.S. by the end of 2011 and analyzing levels of organic and inorganic arsenic in other types of juice as well.

Consumers Union says that the FDA already has the data it needs to set juice standards, and that a guidance level must be followed by the establishment of a legally binding standard.

We’ll continue to follow this issue and update you on any new developments.

Sources:

Consumer Reports

ABC News

Food Safety

In the last few years you probably noticed an increase in the amount of nutritional information on the front of food packaging. This includes graphics saying “all natural” or “better for you.” Others list the amount of sugar, fiber, and fat in the product. Others are endorsements by a health organization. These front-of-pack labels or “FOP” labels are at the center of a controversy that’s pitting the Food and Drug Administration (FDA) against food manufacturers and associations.

Currently the FDA doesn’t regulate Front of Pack labeling, but they are in the process of attempting to develop standards for them which are now defined by each company or organization.

The federal government became concerned about FOP labeling as their use exploded and the labels became increasingly misleading. With different label criteria and label formats from each company, consumers were bombarded with different and often incomplete information. For example, manufactures can tout “sugar-free” or “all natural” for a food that is loaded with saturated fat and virtually no other redeeming nutrients. In essence, foods can be made to appear healthier than they really are.

Last year the Centers for Disease Control along with the FDA asked the Institute of Medicine (IOM) to step in and review the labeling in use, make recommendations on how to clean up the mess and suggest a standard FOP scheme.

In anticipation of the coming standards, the Grocery Manufacturers Association and the Food Marketing Institute developed the Nutrition Keys or “Facts Up Front” system. It consists of at least four basic icons for calories, saturated fat, sodium and sugars per serving. An optional format includes two “nutrients to encourage” (potassium, fiber, protein, vitamin A, vitamin D, calcium and iron). All of these are either shortfall nutrients or are required to be on the nutrition facts panel. This scheme is already in use now and some charge this was a deliberate attempt to undermine the impending IOM recommendations.

“Facts Up Front” FOP labeling system developed by the Grocery Manufacturers Association and the Food Marketing Institute.

Institute of Medicine Recommendations

Just last month the IOM released the second of two reports which contains their recommendations that any FDA approved FOP scheme:

• Prominently display all information based on serving size
• Include calories per serving
• In addition to calories, allow only three other items in any front-of-package evaluation scheme: 1) saturated and trans fat, 2) sodium and 3) sugars.
• Adopt a point system to evaluate food products based on the levels of those three items. Their sample design uses stars to signify points. The more stars a product has, the better it is for you.

The IOM says their recommendations focus on helping consumers make healthy food choices that address Americans biggest health challenges: obesity, heart disease, and certain types of cancer. The rating system is a fundamental--and some say courageous--change for the FDA. Until now the FDA only provided nutrition facts and left it up to the consumer to interpret that information.

Sample of system proposed by the Institute of Medicine.

Industry Response

The food industry favors their “Facts-up-Front” label as it contains information from the Nutrition Facts label already regulated by the FDA. They oppose any scheme, such as that recommended by the IOM, which includes a rating system. The industry cites its own surveys that indicate consumers don’t want to be told by the government what to eat. They also believe that a system that uses interpretive symbols that rate criteria negatively, but do not include positive criteria are inherently unfair and misleading.

Great Britain’s FOP Labels

In case you’re wondering how are neighbors across the pond are handling this controversy, Great Britain FOP labels use a “traffic light” scheme. It rates products based on four criteria: total fat, saturated fat, sugar and salt per serving. (It does not include calories.) Each criterion is color coded red, yellow, or green to indicate if the amount in the product is too low or high. For example, if the amount of sugar is high by their regulatory standards, the sugar symbol is red.

“Traffic light” FOP system used in Great Britain

Whether consumers will use the information to improve their diets is another matter. According to data from the independent research group HealthFocus, nearly half of American shoppers say they would like to see calories, saturated fat, sodium and trans fat clearly labeled on food packaging to help them avoid unhealthy products. However, they found that only 36 percent of obese shoppers read on-pack nutritional information compared to 55 percent of shoppers overall, and obese shoppers were less likely to say that they paid attention to their diet.

Sources:

Food Navigator

Grocery Manufacturers Association

Food Navigator

Facts Up Front

According to a new report by the Environmental Health Trust, the Federal Communications Commission’s test to measure cellphone radiation is flawed making our actual exposure up to 10 times higher than current limits.

The trust’s report, titled “Exposure Limits: The underestimation of absorbed cellphone radiation, especially in children,” charges that the industry-designed process so under-estimates the actual absorption of cellphone radiation that all cellphone users who keep their cellphone in their pockets absorb cellphone radiation above the FCC exposure limit. Further, even if not kept in pockets, when held next to the head, 97% of the population will exceed the certified level of absorbed radiation, and even more so for children who will absorb more than two times the certified cellphone radiation.

The Trust believes the current exposure limits are flawed because the certification process uses a single “test model”--a plastic mannequin head of a very large man. The head is filled with a liquid which assumes all tissues in the head are identical. A robot positions a sensor within the liquid and calculates the maximum Specific Absorption Rate (SAR) with a tolerance of +30%. The FCC exposure limit is SAR=1.6 Watts per kilogram of tissue. Because of the wide tolerance range, SAR values can be 30% higher than FCC exposure limit.

As the adult male test model represents only about 3 percent of the population, the authors report, the test will not accurately predict the radiation exposure of the other 97 percent of the population, including children. And, as many people carry their cellphones near their waist, the current test model doesn’t consider the affect of radiation on other tissues and organs in this region.

A far better system, they say, is an FCC approved process already used extensively within the Food and Drug Administration (FDA). The alternative process uses MRI-scans of a set of real human beings to determine the amount of radiation absorbed in every tissue. It is called, the “Virtual Family” and includes a 5-year old girl, a 6-year old boy, an 8-year old girl, an 11-year old girl, a 14-year old boy, a 26-year old female, a 35-year old male, an obese male adult and 3 pregnant women at 3rd, 7th and 9th months of gestation, allowing for appropriate cellphone certifications for the most vulnerable cellphone users.

Because billions of young children and adults with heads smaller than the current test model are now using cellphones extensively, and because they absorb proportionally greater cellphone radiation, the report states that it is “essential and urgent that governments around the world revise approaches to setting standards for cellphone radiation, to include sufficient protection of children.”

The Environmental Health Trust is a non-profit organization whose scientists have investigated environmental hazards such as asbestos, tobacco smoke and radiation from medical diagnostic equipment. The report authors include three Trust members: Devra Davis, PhD, MPH, former senior adviser in the Department of Health and Human Services under the Clinton administration, Dr. Ronald Herberman, director of the University of Pittsburgh Cancer Institute, and Om Gandhi, a former scientist for Motorola who first performed the research establishing acceptable radiation risk.

Cause for concern?

Whether the radiation from cellphones actually causes cancer or other harmful effects is a question that has yet to be answered. Some studies have found a link between cellphone use and reduced sperm counts in men. Another study found a slight increased risk of a rare form of brain cancer called glioma among cellphone users. We do know that even a short cellphone call can cause increased brain activity for up to two hours later. Whether this causes any harm is unknown.

Until we have consensus, the medical and research community seem to suggest that we exercise caution. You can reduce your exposure to cell-phone radiation by keeping your cellphone away from your head and body by using an earpiece or speaker mode. To learn more about your real risks, check out a recent CNCA newsletter:  Do EMFs from Cell Phones Cause Cancer.

Sources:

ABC News - Good Morning America

Environmental Health Trust

Electromagnetic Biology and Medicine

The Food and Drug Administration is once again reviewing the safety of the chemical triclosan which was developed more than 40 years ago as a surgical scrub for hospitals. Scientists have raised concerns about the safety of triclosan for decades, and while the FDA has studied the chemical, it has not made a definitive ruling on the matter. Meanwhile consumer advocates and some manufacturers that incorporate triclosan in their products are facing off -- with neither side giving an inch. So what’s this fuss all about?

Triclosan is everywhere

Triclosan is now virtually synonymous with the word “anti-bacterial” in consumer products such as soaps (hand soaps, bar soaps and dish soaps), kitchen cutting boards and even toothpaste. It is so ubiquitous that the Centers for Disease Control and Prevention found the chemical present in the urine of 75 percent of Americans over the age of 5.

Two sides to the story

On one side, those who wish to remove or limit triclosan point to the following:

• The FDA has already said that soap with triclosan is no more effective than washing with ordinary soap and water, a finding that manufacturers dispute.
• Several studies have shown that triclosan may alter hormone regulation (thyroid and sex hormones) in laboratory animals or cause antibiotic resistance.

The push in congress by some to enact legislation to regulate the use of triclosan goes back three decades. Currently Massachusetts Representative Edward J. Markey is calling for a ban on triclosan in hand soaps, products that come in contact with food or products marketed to kids.

The makers of Dial Complete, which is at the center of the latest controversy, says there was no real evidence showing that triclosan was dangerous for humans. He also said that several recent studies had proved the effectiveness of triclosan in killing germs, and that those studies had been submitted to the federal regulators. (Dial Complete makes the claim, “kills more germs than any other liquid hand soap.”)

Similarly, Colgate continues to use triclosan in its Colgate Total toothpaste because it has proved to be effective against gingivitis, a claim also approved by the FDA.“The safety and efficacy of Colgate Total toothpaste is fully supported by over 70 clinical studies in over 10,000 patients,” the company said in a statement.

In the face of growing consumer concern, some manufacturers have removed it and reformulated their products to use a less controversial alternative. Reckitt Benckiser removed triclosan from three face washes and Colgate-Palmolive replaced triclosan with lactic acid in Palmolive Antibacterial Dish Liquid and its Softsoap liquid hand soap was reformulated.

For the makers of antimicrobial and antibacterial hand soaps, the outcome of the federal inquiries poses a significant risk as these products represent about half of the $750 million market for liquid hand soaps in the United States.

Triclosan’s long history of FDA review

On three occasions, in 1972, 1978 and 1994 the FDA reviewed and/or proposed eliminating triclosan in hospital scrubs and hand soaps but nothing final was ever authorized.

As for the current review, the FDA was to announce the results several months ago, but now says the timing is uncertain and unlikely until next year. Meanwhile, the Environmental Protection Agency is also looking into the safety of triclosan.

In the meantime, wash at your own risk.

Source:

New York Times

FDA Adds New Warnings to Anti-Seizure Medication

The Food and Drug Administration (FDA) has issued a safety announcement for the antiseizure medication valproate sodium (and related products valproic acid and divalproex sodium) concerning an increased risk for lower cognitive test scores among children born to mothers taking the drug during pregnancy as compared to other antiepileptic medications.

The FDA will also be adding information about the risk of lower cognitive test scores to the valproate product labels and product literature.

Their conclusion is based on epidemiological studies showing that children who were exposed to valproate during pregnancy scored lower on cognitive testing than children exposed to other antiseizure medications. In the primary study, children were tested at age three, however the FDA cited several additional supportive studies, where cognitive tests were performed at ages 5 to 16 years.

The FDA previously warned pregnant women and women of childbearing age about valproate use during pregnancy because of known adverse effects on a developing fetus. The FDA also released a bulletin for healthcare professionals in December 2009 on the risk for neural tube birth defects after exposure to valproate products during pregnancy.

Smoking Cessation Drug May Increase CV Risk

A meta-analysis of randomized trials conducted on the smoking cessation drug varenicline (Chantix) showed that varenicline was associated with a 72% increased risk of serious adverse cardiovascular events compared with placebo.

Conducted by a team of researchers from Johns Hopkins University School of Medicine and Wake Forest Baptist Medical Center, the analysis included 14 trials with a total of 8,216 participants. The trials ranged in duration from 7 to 52 weeks, and all except one excluded people with a history of heart disease.

Lead researchers Drs Sonal Singh and Curt Furberg concluded that the potential for harm far outweighed the benefits of the drug which has a 1 in 10 success rate. Furberg said, "This increase in cardiovascular events adds to the large amount of central nervous system (CNS) reactions reported with varenicline, and highlights yet again how dangerous this drug is. It has only a very modest benefit.”

He is particularly concerned about the CNS side effects. “The drug has been associated with a sudden loss of consciousness, which has led it to be banned from use in pilots and truck drivers, and the Department of Defense has discouraged its use in army personnel working with missiles…It also has the most reports of aggression, hostility and violence of any drug marketed, and these are only the reactions that have actually been reported to the FDA, so just represent the tip of the iceberg," Furberg said.

In a statement, the drug maker, Pfizer, said it disagreed with the interpretation of the data by Singh et al, which the company emphasized was based on a small number of events, "which raises concerns about the reliability of the authors' conclusion." It added that the FDA has asked Pfizer to conduct its own meta-analysis of cardiovascular events in the whole database on the drug.

Regarding the central nervous system effects, Pfizer said, "There is no reliable scientific evidence to say these events are caused by Chantix." It added, however, that it is planning a large trial of varenicline in smokers with and without mental health disorders to look at this further.

Sources:

Medscape – Valproate

Medscape – Varenicline (Chantix)

A few weeks ago we wrote about California’s preemptive move to block genetically modified (GM) Atlantic salmon from being sold in their state - even before the FDA approved its sale. Now the U.S. House of Representatives voted last week on an amendment that prohibits the FDA from approving GM salmon for human consumption.

The bioengineered salmon developed by a Massachusetts company, AquaBounty, grows twice as fast as conventional salmon thanks to the introduction of a growth hormone from a Chinook salmon and another gene from an ocean pout that keeps the hormone active. Normally salmon produce the growth hormone for only part of their life cycle.

The FDA, which is set to approve the modified fish, said there’s no biologically relevant difference between the altered salmon and conventional salmon and it appears to be safe to eat. However an agency advisory panel said more studies may be needed before it is served up on American dinner tables.

Rep. Don Young of Alaska offered the amendment to a farm spending bill that would prohibit the FDA from spending money to approve AquaBounty's application. Young argued that the modified fish would compete with wild salmon in his state. Other critics have labeled the modified salmon a "frankenfish" that could possibly cause allergies in humans and eventually decimate the wild salmon population.

The amendment was approved by voice vote. The House is expected to pass the farm spending bill. The Senate has not weighed in on the issue.

So far, the FDA has considered but not approved any GMO animals for human consumption — the salmon would be the first. Some believe approval of the salmon would open the door for a variety of other genetically engineered animals, including a more environmentally-friendly pig that is being developed in Canada or cattle that are resistant to mad cow disease. Each would have to be approved by the FDA.

Sources:

Daily Mail

A recent warning letter from the Food and Drug Administration (FDA) to a manufacturer of contaminated Ginseng supplements underscores the need for manufacturers to conduct more stringent testing to ensure that their supplements have maximum freedom from contaminants.  

In the letter, the FDA reported that inspectors found ginseng supplements contaminated with the pesticides chlorpyrifos and pentachlorobenzonitriles. Chlorpyrifos disrupts the nervous system causing nausea, dizziness and confusion. Exposure to pentachlorobenzonitriles may cause skin, eye and lung irritation.

The FDA cited their no-tolerance policy for the pesticide chemical residues saying, “It is your responsibility to ensure that your establishment is in compliance with all requirements of the federal regulations. Moreover, it is your responsibility to produce safe products."

This isn’t the first time that ginseng contamination--or similar issues with other herbals-- have been reported. In 2010, the independent testing lab, Consumerlab.com reported that five out of eleven ginseng supplements selected for testing were contaminated with lead and/or pesticides or contained less ginseng than reported on their labels. Consumerlab.com reported a history of quality problems with ginseng supplements dating back to 2000.

Last year a Congressional investigation of herbal dietary supplements found that 16 of the 40 supplements tested contained pesticide residues that appeared to exceed legal limits.

Ginseng and many other herbal supplements may be exposed to pesticides, herbicides, and other environmental toxins prior to harvest. These contaminants have been found in domestic and imported samples at similar frequencies which dispels a common myth that domestic sources are safe. According to a 2004 FDA report, 60% of 62 imported ginseng samples were found to be contaminated compared with 57% of 79 domestic samples.  

FDA regulations require manufacturers to verify the identity of raw ingredients-- in this case, that the ingredient is indeed ginseng. But the regulations do not require supplement makers to test for what shouldn’t be there unless there is a “reasonably anticipated contaminant” likely to be present. Therefore quality testing for all contaminates known to be common to any specific herbal product should be a part of all manufacturers’ quality assurance protocols. In practice, however, manufacturers can pretend that there isn’t a potential for contamination and simply not test for it.

“Far too few manufacturers go beyond the minimum of identity testing to consistently include testing for common contaminants,” said CNCA Director, Neil Reay. “CNCA uses independent labs to test all raw ingredients beyond what is required by the FDA and rejects all raw materials that do not meet our standards. And, every bottle bears a quality pledge that lists the tests performed on that product,” said Reay.  The quality pledge on a bottle of CNCA ginseng reads:  Independently tested for authenticity, potency, heavy metals, solvent residue, herbicide & pesticide residue, aflatoxins, stability and bacteria, yeast and mold counts.

FDA warning letters are a constant reminder that supplement users need to choose their supplement brands carefully and only after researching their quality standards and testing protocols. To learn more about how to choose the best quality supplements, review our series of Supplement Savvy articles.

Sources:

Natural Products Insider

FDA

Consumerlab.com

National Library of Medicine: Hazardous Substance Database

U.S. Environmental Protection Agency:  Pesticide Facts

In recent weeks, Lazy Cakes “Relaxation Brownies” have had the opposite effect on some public officials who are upset that the products in cartoon packaging may appeal to children but contain adult doses of the dietary supplement ingredients melatonin, valerian root and passion flower used to promote relaxation and sleep.

Each Lazy Cakes brownie contains roughly 8 milligrams of melatonin. The typical amount of melatonin recommended to support sleep in adults is usually not more than 3-5 milligrams. Melatonin is not usually recommended for children as a sleep aid.

So far, Mayors in two Massachusetts cities have sought to ban the brownies based on reported cases of children who were hospitalized when they became extremely lethargic after eating the brownies. Other municipalities and at least one state quickly followed suit and now U.S. Senator Dick Durbin has asked the Food and Drug Administration (FDA) to step in and rule on the safety of foods containing dietary supplement additives.

This controversy raises an important question. Are Lazy Cakes a food or a supplement? The answer determines how they are regulated by the FDA. Food ingredients must be generally regarded as safe and gain approval as a food additive. (The FDA has not approved melatonin as an additive in foods.) Because Lazy Cakes brownies are labeled and marketed as dietary supplements, and not subject to the requirements of foods, they are not required to have approval to include melatonin.

The Council for Responsible Nutrition issued a statement regarding the growing controversy. “Conventional food products, including cakes and brownies that are fortified with a dietary ingredient such as melatonin, are not dietary supplements despite being labeled that way; they are mislabeled conventional foods,” said CRN president and CEO Steve Mister. More...