Category : FDA

Home/Archive by Category" FDA"

The Bonvie Blog: The Labeling Trick Only the FDA Could Pull Off

The Labeling Trick Only the FDA Could Pull Off

By LINDA and BILL BONVIE

Ready or not, Halloween is coming around again.

For many, it’s a fun holiday that opens the magic portal to the holiday season. But for others, not so much!

In the UK a recent poll found that 45 percent of Brits consider trick-or-treating an “unwelcome American cultural import.”

No matter how you feel about it, however, like everything else these days Halloween comes with a wide variety of rules and restrictions. That’s right – it’s not the happy-go-lucky boo-fest of years gone by anymore.

For example:

  • In the LA suburb of Walnut, Calif., wearing a “mask or disguise on a public street” is an unlawful activity.
  • If you live in Alabama, dressing up like a minister, nun, priest or any “other member of the clergy” can land you in the county jail forking over up to $500. (So much for that flying nun costume.)
  • Trick-or-treating over the age of 12 is forbidden in Newport News, Va. And even if you’re young enough to walk the streets as a ghost or goblin, you better get home before 8 p.m. or you could be charged with a Class 4 misdemeanor.

But here’s where some rules could really make a difference, and help in your search to find treats to give out to your visiting ghouls and ghosts.

The labeling lingo that’s worse than nothinglabeling

As you probably know by now the FDA’s big makeover of the Nutrition Facts Label (or NFL) – something that had been in the works for ages – was finally rolled out a little over two years ago.

Basically, this “new and improved” method to help consumers more easily select healthy processed foods is a slap in the face to science. But the top travesty of all can be found in the section that tallies up the “sugars” content – most especially the part called “added sugars.”

In that category, every type of caloric sweetener, healthy or otherwise, is considered to be nutritionally the same. Sucrose (a.k.a. sugar of all varieties), fructose, high fructose corn syrup, molasses, maple syrup, honey, and more, are all lumped together and measured in grams on the same line.

In fact, Citizens for Health filed a petition with the FDA over four years ago asking the agency to include not only the name of the added “sugar,” but the amount of processed fructose contained in HFCS, which can range from 42 to a whopping 90 percent.

And recently, the name “glucose-fructose syrup” has been popping up on ingredient labels. What is it? Nothing more than another way to say high fructose corn syrup.

The Corn Refiners have been trying to get away with spiking the fructose content of their laboratory sweetener and changing its name for years. And it looks like they may be succeeding on both counts.

So what does this mean when it comes to picking out Halloween treats?

Well, if you go by the FDA’s fancy new labeling, it could result in not knowing the difference between what’s a good choice and an absolutely frightening one.  

So, here’s what you need to do: Skip the nutrition facts label altogether and go directly to the actual ingredients listing instead. Candy certainly isn’t a health food by any means, but there are plenty of treats on the market that won’t break the bank and contain ingredients that you can feel good about handing out to the neighborhood witches and wizards.

And remember, avoiding HFCS isn’t just something you want to do on Halloween. Time and time again research has found this laboratory sweetener is linked to high cholesterol and triglycerides, obesity, and an increased risk of heart disease and diabetes.

And that’s about as scary as it gets.


Linda and Bill Bonvie are regular bloggers for Citizens for Health and the co-authors of Badditives: The 13 Most Harmful Food Additives in Your Diet – and How to Avoid Them.

The Bonvie Blog: FDA Bans Carcinogenic Additives

FDA bans seven cancer-causing food additives. How many more are out there?

After a 30-year hiatus the Delaney Clause makes a return appearance

By LINDA BONVIE

Late last week the FDA announced the ban of seven food additives known to cause cancer.

These consist of a group of tongue-twisting chemicals such as synthetically derived benzophenone, eugenyl methyl ether and one called pulegone. They’re added to beverages, bakery products, cereals, candy, gum and ice cream for a taste of cinnamon and peppermint, a twist of citrus or even the flavor of roasted onions.

These fake flavorings have been used since the 1960s – and they can still be quite legally added for the next two years. Don’t bother checking labels for them, however, as they all fall under the category of “artificial flavors.”

The FDA’s decision to ban them was due to a petition submitted to the agency – as well as a subsequent lawsuit — from 10 public interest organizations, including the Consumers Union, Natural Resources Defense Council and the Environmental Working Group (EWG).

But in a food supply filled to the brim with a mad scientist’s array of extremely dangerous additives (MSG, HFCS and aspartame, to name just three), why was this bunch given the boot? It’s especially intriguing since the FDA said in announcing its decision that the seven “do not pose a risk to public health.”

In an oddly logical turn of regulatory reasoning — despite the agency’s steadfast opinion that these additives are as “low risk” as can be — it said they were being revoked “as a matter of law.”

That law is the Delaney Clause. Added to the Federal Food Drug, and Cosmetic Act in 1958, it states that “no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal…”

If you’re not familiar with Delaney it could be because it hasn’t made an appearance since cell phones were as big as a brick, around the late 1980s. And by applying the literal meaning of the law, instead of brushing it aside with what’s known as the “de minimis exception” (which is described as a “trivial” hazard, a lifetime cancer risk less than one-in-a-million), it appears that seven unnecessary and risky food additives will bite the dust at some point in the future.

Of course, the Delaney Clause has been nitpicked for decades as being overly cautious and outdated. And then there’s the argument that we know so much more about what causes cancer these days than we did back in the 1950s.

But that’s not entirely true.

While our medical knowledge bank may have increased since then, still, no one can say with certainty that there’s a magic level at which a carcinogen is somehow safe to consume – especially where kids are concerned.

And anyone who claims they know otherwise is simply making a wild guess.

Remember, these seven chemicals have been hiding in the food supply for decades under the guise of “flavorings.” And there are untold numbers more.

As the Environmental Working Group’s nutritionist Dawn Undurraga says, while this is a “positive step forward,” until the FDA mandates that manufacturers give consumers complete “ingredient disclosure,” we can’t make our own “fully informed decisions” about the foods we buy.

According to the EWG, one of every seven conventional (not organic) food ingredient labels lists “artificial” flavorings, with “natural” flavors being even more popular. And both names will tell you absolutely nothing about what those ingredients may consist of.

It’s a loophole that food manufacturers love. But as for consumers, the only safeguard we have right now is to reject every single product made with these secret ingredients.


Linda and Bill Bonvie are regular bloggers for Citizens for Health and the co-authors of Badditives: The 13 Most Harmful Food Additives in Your Diet – and How to Avoid Them.

Continue Reading

The Bonvie Blog: Read Your Labels Day 2018

‘Read Your Labels Day’ – Now More Important Than Ever!

By LINDA BONVIE and BILL BONVIE

What makes this April 11, Citizens for Health’s sixth annual Read Your Labels Day, perhaps the most important one yet?

Two developments, actually. One is a USDA decision to override the National Organics Standards Board’s (NOSB) vote (taken well over a year ago) to stop allowing the seaweed-based thickening agent carrageenan to be used in organic processed foods.

Carrageenan, as it happens, is one of the 13 most harmful food additives we targeted in our book Badditives!  

It’s an ingredient that has a terrible effect on many people’s digestive systems, with even small amounts of the “food grade” variety having been found to cause inflammation in the colon (and samples of that food-grade variety have all been found to be contaminated with a “degraded” type that’s considered a possible carcinogen).

This isn’t just theoretical, however. The Cornucopia Institute, a consumer-safety watchdog organization, has collected a sizeable number of descriptions of the gut-wrenching symptoms people have suffered until eliminating carrageenan from their diet. The Institute likens it to “putting poison ivy in skin lotion.”

But despite such research and reports, the recommendation of the NOSB, and the fact that harmless alternatives, such as guar gum, are readily available, the USDA saw fit to cave in to industry groups that claimed carrageenan was better in terms of “taste and texture,” would make organic products more competitive, and as one lobbyist put it, would allow consumers “to continue to enjoy the foods they know and love.”

This decision, which is the sort of thing we’ve come to expect of the “deregulating” Trump administration, makes reading labels for the presence of this “thickener that’s a sickener” (as we called it in Badditives!) an absolute must — even if you purchase exclusively organic processed foods.

The Icon that Tells You Everything You Need to Know

But this egregious edict on carrageenan isn’t the only reason why we need to be more vigilant than ever about what’s in the food products we buy.

There’s also the fact that the FDA, now under the command of the Trump administration’s Dr. Scott Gottlieb, has just announced plans to launch its own “consumer friendly” campaign to tell Americans what is and isn’t good for them when it comes to food – complete with a simplistic icon that will supposedly tell us at a glance what foods are “healthy” (a device even less meaningful than the existing “nutrition facts” label).

Consider for a moment the implications of such a scheme.

Who will be deciding what’s healthy and what isn’t? Will all it takes to land a big “H” for your processed food product be that it’s low in sodium (and likely high in MSG)? Will low-fat fake creamers make the grade, but organic coconut milk fail?

And could this end up being a big money-raiser for the agency, similar to its Prescription Drug User Fee Act — the payment by drug makers of a substantial sum to submit a new drug application (and which has funded the agency to the tune of $7.67 billion since it went into effect in 1992)?

Whatever this healthy icon idea morphs into, it’s a safe bet that such new guidelines will have the guiding hand of industry behind them – especially given Gottlieb’s statement that the FDA wants to “maintain the basic nature and nutritional integrity of products while allowing industry flexibility for innovation.

If we read between the lines of that statement, what he really seems to be saying is that the agency has no real plans for reforming the “basic nature” of processed-food industry practices and the products that result from them (whose “nutritional integrity” still leaves an awful lot to be desired).

All of this, according to the commissioner, will be on a scale comparable to the agency’s initiative, announced last summer, to make cigarettes less addictive by lowering levels of nicotine. “Improving the nutrition and diet of Americans would be another transformative effort toward reducing the burden of many chronic diseases, ranging from diabetes to cancer to heart disease,” he proclaimed, whose benefits would “almost certainly dwarf any single medical innovation or intervention.”

Indeed it might – if the FDA were really intent on finding genuine ways to promote a healthy diet. But this is an agency that admittedly isn’t even sure what the words “healthy” and “natural” mean, as part of its new effort includes asking for input from the public on those definitions.

And if any more proof of that were needed, it can be found in Gottlieb’s stated aim to “make labeling nutrients more consumer friendly” and “explore updating standards of identity, which are essentially requirements for what can or can’t be in certain products in order for them to be labeled accordingly.”

How would this work, exactly? Well, the two examples he offers are allowing “alternative names” to be used for potassium chloride “to make clear it’s salt” and changing that standard of identity, say, for cheeses that now “aren’t allowed to use salt alternatives that would lower the sodium content and still call themselves cheese.”

Could another possible plan be to allow a labeling request that the FDA rejected a couple of years ago – a proposal made by the Corn Refiners Association to dispense with the name high fructose corn syrup and call it “corn sugar” instead?High Fructose Corn Syrup Labels

So while promoting greater consumer awareness of what makes for a healthy diet is certainly something that would benefit us all, what the FDA is now proposing sounds more like rearranging the rhetorical deck chairs on the Titanic. If the agency were really serious about initiating reforms, it would be talking about imposing stricter standards on the industries it regulates rather than distracting us with cute little icons.

All of which is why we can’t afford to let our guard down when it comes to reading (and reading up on) those lists of ingredients on processed foods.

And it’s why “we’re from the government and we’re here to help” has never been a less credible claim than it is right now.


Linda and Bill Bonvie are former writers of the CFH Food Identity Theft blog and co-authors of Badditives! The 13 Most Harmful Food Additives in Your Diet – and How to Avoid Them

 

 

 

The Bonvie Blog: Alzheimer’s

Is a New Drug Strategy Really What We Need to Prevent Alzheimer’s?

 By LINDA BONVIE and BILL BONVIE

So what’s up with the Food and Drug Administration (FDA)? An agency that has been derelict in its duties of protecting the public for quite some time now appears to have gone completely off the rails (as have other regulatory entities) since the Trump administration began systematically removing any of the remaining constraints on industry’s most reckless impulses.

A prime example is the way the FDA has given Big Pharma carte blanche to proceed with the marketing of untested preventives for Alzheimer’s following the abject failure of a couple hundred meds to treat it (Merck being the latest to acknowledge that by halting a trial of its latest drug, joining other unsuccessful attempts by the likes of Pfizer and Eli Lilly).

The agency, under its new commissioner, Dr. Mark Gottleib (the same guy who’s been cracking down on the use of kratom, the one promising natural alternative for getting people off opioids, as we reported a couple months ago), has just proposed opening a new road into some rather thorny territory where none have gone before.

What the agency is now offering drug makers is the prospect of fast-track approval for an Alzheimer’s-averting drug sans the type of “widespread evidence-based agreement in the research community” that has been previously required.

In other words, our supposed governmental watchdogs are now inviting companies to experiment with drugs on untold numbers of people who not only don’t yet have Alzheimer’s, but may never even develop it. And all based on the idea that certain biological markers might provide an early indication of a person’s likelihood of getting the disease.

Of course, the fact that such meds will inevitably produce all sorts of side effects (some of which might even mimic the symptoms of dementia) in otherwise healthy people doesn’t even appear to be a consideration.

But while all the pharmaceutical industry’s researchers and resources might not yet have come up with patentable remedies for Alzheimer’s, or even identified its root cause (for example, the fact that some people whose brains contain the key suspect, beta-amyloid plaques, have no apparent signs of dementia), there are things we do know about its prevention that don’t involve prescribing risky drug regimens with as-yet undetermined consequences.

Perhaps nowhere has that been more evident than in the results of a study done at UCLA that were published two years ago in the journal Aging, and involved a series of lifestyle modifications known as the metabolic enhancement for neurodegeneration, or MEND. It involved just 10 patients ranging in age from 49 to 69 – but the cognitive improvements they showed over periods ranging from five months to two years were remarkable.

The UCLA program used in this study was a personalized one that included a focus on healthier eating, improved exercise and sleep patterns, and dietary supplements, as well as fasting and stress reduction techniques.

And an astounding nine out of the ten participants were found to have reversed memory loss and sustained those improvements using such therapies, according to the paper’s author, neurology Professor Dale Bredesen, Director of the Easton Center at UCLA.

Now skeptics, of course, might try to dismiss this study as being too small to matter much. But the very fact it was so small made individual outcomes much easier to gauge than had it been one involving hundreds or thousands of subjects. For example:

  • The symptoms and neuropsychological testing of a 69-year-old patient with well-documented Alzheimer’s disease ‘improved markedly” after 22 months on the program.
  • A woman in her late 50s who had shown symptoms of progressive cognitive decline, like returning home from shopping without the items she had purchased, forgetting familiar faces and not knowing which side of the road to drive on, not only showed “marked improvement,” but sustained it for three-and-a-half years.
  • A 49-year-old patient whose memory had begun to decline, not only forgetting things like faces and scheduled events but losing the ability to speak two foreign languages, got it back and had a “normal neuropsychological examination” nine months after starting the MEND protocol.
  • A 50-year-old woman who had developed memory problems that made it difficult for her to drive, find words and follow recipes, after only three months on the program, was able to babysit her grandchildren, follow written and verbal instructions without any problems, and read and discuss her reading with her husband – which she had not been able to do prior to treatment.

So what’s the magic formula that brought such changes about?

It varied with each individual, but included such components as eliminating simple carbohydrates, gluten and processed food, and replacing them with vegetables, fruit and non-farmed fish; supplementing daily with vitamin D3, CoQ10 and fish oil, and melatonin at night; reducing stress through yoga and 20-minute, twice-daily meditation, 30 minutes of exercise four to six times a week, and getting 7-8 hours of sleep per night.

Oh – and one other thing. While the combining of these various elements seemed to be a key to those improvements, it’s not necessary to do them all to get results. And the only other effect, according to Prof. Bredesen, is “improved health and an optimal body mass index, a stark contrast to the side effects of many drugs.”

In other words, Alzheimer’s – or the dementia that many people experience with age – may be both preventable and treatable without the help of Big Pharma, and whatever new and untested drugs with which it may yet be planning to experiment on us. And without the FDA trying to run interference with such efforts on behalf of the Trump administration’s friends in industry.

Linda and Bill Bonvie are the authors of Badditives! The 13 Most Harmful Food Additives in Your Diet –and How to Avoid Them.

 

 

 

 

CFH VP James Gormley Shares a New Year Message

Happy New Year to all of our supporters, friends, allies and readers.

Now that the wrapping paper is gone and noisemakers are stowed, we wanted to send this very brief note looking back at (and forward to) a few issues relating to natural products, health and the environment.

First, there is general uncertainty as to whether the anti-over-regulatory winds in Washington will blow elsewhere in the U.S., especially in states such as New York and California, which have what some would call a hyper-regulatory, or nanny-state, posture in regards to many products, including dietary supplements.

In some cases, strong regulations can serve consumers well—such as with food safety and the environment. In other cases, such as with Prop 65 in California, excess caution paints virtually all products and materials with the “potentially carcinogenic” brush, benefiting no one.gormley

As we enter the New Year, the U.S. Justice Department issued a directive that appears to effectively nullify states’ efforts to legalize marijuana. While we at CFH don’t take a universal position on this plant, as such, we do recognize the botanical’s vital importance for medicinal use. As for other applications, we believe it is up to the states to listen to their citizens, and that it is not up to the U.S. government as it stands on what it perceives to be a moral high ground and attempts to impose its view on all 50 states and all Americans, for that matter.

“In California, we decided it was best to regulate, not criminalize, cannabis,” said California Attorney General Xavier Becerra. “Unlike others, we embrace, not fear, change.” This is an attitude that we can support, in this case and in general.

Second, regarding dietary supplements—on the plus side we have seen growing interest among natural product makers to use clean labels, labels with recognizable, more natural and often sustainable ingredients. Related to this trend is transparency, including such matters as country-of-origin labeling (COOL), which CFH actively supports.

Keeping products honest in all ways fortunately took on greater steam in 2017, and we have seen more clamp-downs on a handful of companies that spike their supplements with drug ingredients.

There has been robust discussion about kratom (an herb in the coffee family, Mitragyna speciosa) and its relative merits, which is good. However, scapegoating one botanical after another from the market under the guise of safety, as we saw with ephedra (Ephedra sinica) some years back, is never a good idea.

The movement to support local farmers, manufacturers, bakers, brewers – and, yes, even candlestick makers – is a welcome wave, although not new, as such. It is, in some ways, merely bringing us back to the days before cargo planes and high-speed trains started to blur the lines between what’s available when and where—in what seasons and in what climates.

Third, speaking of climate and our environment—in recent days we have seen that the U.S. is very close to allowing oil drilling in most U.S. continental-shelf waters, including protected areas of the Arctic and the Atlantic, which is of great potential concern to the integrity of our water and land, and the creatures who rely on them, including all of us.

As we look forward to the rest of 2018, we should encourage the companies whose products we like to maintain their commitment to values we care about and to continue to spread the word about how dietary supplements and natural medicine can help us achieve optimal health and make our lives better.

We sincerely thank you for being involved and for staying informed about the issues that impact our health freedoms.

Your participation is a critical part of our efforts to ensure that the flame of our collective dedication to natural health is never extinguished.

 

Yours in health,

James Gormley

Vice President, CFH

 

 

The Bonvie Blog: Kratom

The good news is that there may well be a relatively simple way for many individuals now caught up in the ongoing nationwide opioid crisis to pull themselves out of it. And that’s no small thing, considering that that this man-made catastrophe has killed an estimated 20,000 Americans from overdoses in 2016 alone. The bad news is that the federal government is trying its best to make such apparent salvation illegal.

Stop 21st Century Cures Act

Although this is coveted as a wonderful bill that is needed in the US so that drugs and medical devices can be fast tracked, if you read the nearly 1000 pages it is clear this is dangerous bill that is has the best interests of the Pharmaceutical industry at heart, NOT its consumers.

Dental Mercury Linked to Risk for Brain Damage

The following is reprinted with the permission of McClatchyDC

Dental group defends mercury fillings amid mounting evidence of risks

For decades, the American Dental Association has resolutely defended the safety of mercury fillings in the teeth of more than 100 million Americans, even muzzling dentists who dared to warn patients that such fillings might make them sick.

Senate Hearing Bodes Ill for GMO Labeling

“Monsanto’s Dream Bill” – also known as the Safe and Accurate Food Labeling Act, HR 1599, and the “DARK Act” – standing for the Deny Americans the Right to Know Act would ban states from passing legislation to label food and products containing GMOs (genetically modified organisms), undoing years of hard-won progress at the states level made by food labeling advocates like Citizens for Health and Food and Water Watch.

Sign the petition from Food and Water Watch Now!

Now there is a renewed sense of urgency stemming from testimony at a Senate Agriculture Committee hearing held yesterday. The Biotechnology Industry Organization (BIO) and food manufacturers were out in force to protect their interests by confusing the debate with repeated assertions about the safety of GMOs. It didn’t help that Ag Committee Chair, Senator Pat Roberts (R-KS), and Ranking Member Debbie Stabenow (D-MI), demonstrated they have drunk the industry Kool-Aid when they wasted spectators’ time making the same claims about GMOs’ safety.

The issue is not one of safety, even though there is compelling evidence that we should be concerned about the prevalence of GMOs. As Consumers Union director of food policy initiatives, Jean Halloran has noted, “Safety is not the point. Almost all the labels required on food—such as ingredients and fat content—are informational. So is GMO labeling. The debate over GMO labeling is about consumers’ right to know what they are eating.”

A joint letter from a bi-partisan group of state lawmakers urging Congress to oppose HR 1599 also points out that a District Court in April affirmed that states have a constitutional right to pass GMO labeling laws. Whether everyone agrees they are safe – or not.

Senator Stabenow called for “a bipartisan bill that can pass the Senate by the end of this year.”

Don’t let the biotech industry and food manufacturers hide behind questionable claims about the safety of GMOs as they trample over the US Constitution and your right to know.

Preserve your right to know – sign the petition today!

Officials Kill Proposal to Curb Mercury Fillings

Proposed Warnings Have Been Kept Secret for More Than Three Years

or the first time tFood and Drug Administration has proposed curbing dentists’ use of mercury in treating Americans’ decayed teeth. This would be a major step forward in protecting Americans from one of the planet’s nastiest toxins.

 It would be – if senior U.S. health officials hadn’t put the kibosh on the proposal after a cost-benefit analysis by officials at the Department of Health and Human Services.

The proposal, which was approved by FDA officials in late 2011 and kept under wraps ever since, would have advised dentists not use mercury fillings when treating cavities in pregnant women, nursing moms, children under 6 and people with mercury allergies, kidney diseases or neurological problems. It even went so far as to urge dentists that when considering using mercury fillings, the best course of action is simply not to – ever.

For your convenience, we have attached the FDA’s recommendations here – please share far and wide: FDA 2012 Safety Communication Mercury

To read more of the article exposing the cover-up, click here: Health Officials Kill Proposal to Curb Mercury Dental Fillings