"Approved" and "Qualified" Claims

Everyone knows that a product cannot be held to "prevent or cure" a specific disease or condition without first undergoing rigorous, extensive testing to satisfy the FDA that the product both does what it says it does and does no harm in the process. Such testing very expensive and well beyond the budget of most product managers.

Products that do not complete such testing still have some options for making health claims on their packaging though.

"Authorized" health claims in food labeling are claims that have been reviewed by FDA and are allowed on food products or dietary supplements to show that a food or food component may reduce the risk of a disease or a health-related condition. An example of an Authorized Health Claim can be found on every box of Cheerios cereal. 

"Three grams of fiber daily from whole gain oat foods like Cheerios cereal, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease."

No fine print. No asterisk. The FDA has determined that there is sufficient scientific evidence supporting the claim, and that the product does indeed contain whole grain oats, to allow General Mills to make this claim on its packaging. Such claims are supported by scientific evidence and may be used on conventional foods and on dietary supplements to characterize a relationship between a substance (a specific food component or a specific food - whole grain oats) and a disease or health-related condition (e.g., heart disease). Its not a very high bar, but its not a lie.

And yet it is too high a standard for many producers.

Thus we have the "Qualified" health claim. Qualified health claims are supported by some scientific evidence, but do not meet the significant scientific agreement standard. Read that again. They do not rise to the standard of significant (let alone conclusive) scientific evidence. In order to distinguish it from an Authorized claim, the FDA requires Qualified claims to bear a footnote stating that "The FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent." In other words, maybe it does what it says. And maybe it doesn't.

An example of a Qualified Health Claim would be Ocean Spray Cranberry Juice Cocktail (basically cranberry flavored sugar water) claiming prominently that 

"Consuming one serving each day of Cranberry Juice Cocktail may help reduce the risk of recurring urinary tract infection in healthy women."

The evidence for that is mixed," according to Ruth Jepson, professor of public health at the University of Edinburgh. "Cranberry juice does not appear to have any significant benefit in preventing UTIs."

Yet there it is, right on the bottle. Also on the bottle, in teeny, tiny print that you are lucky to even find let alone read, is the FDA's qualifying statement. Its bad enough that people can be mislead by claims like theses, but often the product is not even a remotely healthy choice.

As always, no one had you back on this, so caveat emptor.

Five Ways to Make Thanksgiving Dinner Healthier

Thanksgiving is not the time for a lecture on diet or to leave yourself feeling deprived. This has been a rough year for everyone and there is no better time than Thanksgiving to pause and reflect on all of the good things in our lives that we have to be grateful for - even in 2020. And food is always a part of the holiday.

Here are some things you can do to make you meal healthy as well as fun and delicious rather than instead of fun and deliscious. Feel free to share any tips of your own.

 

1. Turkey is a great source of lean protein, but many Thanksgiving preparations call for way too much salt. Try omitting the salt and seasoning your turkey with flavored herbs such as garlic, rosemary, oregano, cilantro and parsley instead.

2. Traditional stuffing can be made much healthier without sacrificing any taste! Exchange the white bread for 100% whole-wheat bread to increase fiber and substitute olive oil for the butter. (1Tbsp of butter equals 2tsp of olive oil.) Toss in some walnuts or almonds and who says you can't add some cranberries right into the stuffing? (No offense to those who prefer to call it dressing!)

3. Incorporate a wider variety of vegetables than usual. Many of the vegetables that are in season during the fall and winter are superfoods packed with nutrients. Brussels sprouts (roast them in garlic and oil!), pumpkins, squash (makes a great, easy soup), and so much more! Bake or sauté your vegetables with garlic, olive oil and herbs as delicious and healthy side dishes. Try something new.

4. Go easy on the alcohol. Don’t forget those alcohol calories add up quickly. By all means have a celebratory drink and a glass of wine with dinner. And in between alcoholic drinks, enjoy some sparkling water. This way you stay hydrated, limit alcohol calories, and stay sober.

5. Savor slowly. Eating slowly, putting your fork down between bites, and tasting each mouthful is one of the easiest ways to enjoy your meal and feel satisfied with one plate full of food, experts say. Choosing whole grains, fruits, vegetables, broth-based soups, salads, and other foods with lots of water and fiber add to the feeling of fullness. So does giving your tummy a chance to catch up with your mouth.

Here are a few healthy recipe suggestions for Thanksgiving from Food Network.


And finally, don't forget to be realistic. The holiday season is a time for celebration, not diet Nazis. With busy schedules and so many extra temptations, strive for weight maintenance instead of weight loss. Don't beat yourself up if you overdo it once or twice. As long as you swing right back into your regular diet and exercise routine later its not going to be a weight disaster for you. In fact, most people gain only 2 or 3 pounds over the holiday eating season. As long as it comes off soon, you are good.

Have a wonderful Thanksgiving and stay safe.

Three Ways Food Producers Mislead You

 

Eating a healthy diet ought to be simple. You already know what is good for you and what isn't. But it isn't easy at all. Everywhere you turn you are confronted by mountains of cheap, tasty, readily available food. And food producers are spending billions of dollars every year to make sure you eat as much of it as you can find.

Everybody eats. Everybody buys food. Its a big business. And many of those billions of dollars find their way into the campaign coffers of politicians who then keep the regulators off the food producers back.

But you should know the three ways in which the food companies deliberately and effectively mislead you.

1. Advertising.

The companies that deal in the unhealthiest of foods are also the ones spending the most to grab your attention. They target their advertising at black and Hispanic youths especially, although none of us are immune. Even after many of these corporations publicly pledged their commitment to promoting healthier eating, their dollars are still trying to convince you to do otherwise. Food companies spent $11 billion on television ads alone in 2017, and 80 percent of that, about $8.8 billion, was spent on their unhealthiest offerings ― sugary soda, fast food, candy and unhealthy snacks - and targeted at minorities and children.

These ad dollars are devastating in light of the ongoing obesity epidemic in America, which affects almost 26 percent of Hispanic children and 22 percent of black youths, compared with 14 percent of white children, according to the CDC. According to the American Heart Association, "Children are regularly exposed to advertising and marketing through television, the internet, magazines, schools, product placements, video games, cell phones, and other means. These advertisements are designed to boost brand recognition, sales, and loyalty, more often for unhealthy, high-calorie foods. Unfortunately, most of these products have excessive amounts of added sugar, salt, and fat, and inadequate amounts of fruits, vegetables, and whole grains."

Food companies use all sorts of clever ways to boost consumption, including celebrities, musicians and athletes endorsing products they, themselves, do not eat. No wonder we keep getting fatter and fatter.

2. Misleading Claims on Food Packaging.

We've all seen it. There is is in large print right on the front of the package. Helps Build a Strong Immune System! Supports Heart Health! Contains Real Fruit! All Natural Ingredients! Most of us miss the fine print hidden way down at the bottom in a font so small you can't even see it, let alone read it, that says that the FDA does not approve the claims. Some claims, such as "natural" do not even have a legal meaning and so can be applied to anything. And are. Content claims are especially misleading. Often the touted ingredient is there in such a small amount that it serves no purpose at all other than allowing the company to legally proclaim it is there.

3. Sneakily designed "clinical trials" that prove nothing.

Industry-funded research nearly always comes out in the favor of whoever is paying for it, and if it doesn't it never sees the light of day. There are dozens of ways to fake research results. Some of the most popular are to prove something that has no relevance to the product's claims, using poorly designed studies that often employ badly flawed methodologies, "publication" in industry owned or non-peer reviewed journals, failure to include a control group in the study and using a study group so small that the results have no meaning.

Just because something says "clinically proven" doesn't mean that it is.

 

And by the way, all of this applies to supplement manufacturers just as much as to food producers.

When it comes to the food you serve yourself and your family, there is no one looking out for you but you. Fortunately, there are two things that you can do to protect yourself.

First, learn what a portion is and adjust yourself to it. Larger portions mean more calories, more preservatives and more of everything else.

Second, eliminate as much fast food and ultraprocessed food from your diet as you can. Just stop buying it. You won't likely be able to get rid of it all. That's ok. You don't have to be perfect. But the more crap food you replace with real, unprocessed food, the better off you will be.

Soup Simply

"Soup is good food" says soup maker Campbell's. The truth is, it depends.

Soup is usually a good source of nutrients for not a lot of calories. But it can also be overloaded with sodium. Making your own soup gives you control over the sodium content without sacrificing any of its nutritional benefits. If you avoid making your own soups because you think it is complicated or time consuming, the following generic recipe will change your mind.

1. Create the base.

In a medium to large pot, saute a couple of carrots (sliced), a small onion (chopped) and a stalk of celery (sliced) in a little bit of oil (olive or canola). Toss in whatever seasonings you enjoy. Garlic, ginger, curry powder, cayenne pepper, oregano, thyme, paprika, basil and rosemary are all good. Experiment to find the mix you like.

Add 5 - 6 cups of beef, chicken or vegetable broth or stock. Stir it together and let it simmer.

2. Toss in the vegetables you like.

Add in about 2 cups of vegetables. You can use fresh but frozen works just as well without the prepping. You can use anything here. Beans, broccoli, cauliflower, peas, corn, carrots, tomatoes, potatoes, cabbage, mushrooms. Its all good. If you want to use a leafy green like spinach, go for it. Just add them in toward the end of the cooking time.

3. Gain some grain.

Grain ups the fiber content and gives you more texture and flavor. You can use pasta, barley, quinoa, rice or whatever you like.

4. Now some protein.

Beef, chicken, pork, seafood, whatever you have on hand. You can even use a cup of tofu or more beans if you prefer.

5. Go do something else for a while.

Let the whole thing simmer on low heat for 20 - 30 minutes. Its fine to sneak a little taste, and go ahead and add SMALL amounts of spices to taste if you like (you can always add more but once its in there, its in there).

That's it. Enjoy your creative creation. Most any soups will keep in the refrigerator for a week so go ahead and make extra to save you some stove time later.

If you prefer a thick soup such as squash or potato, there is a little more prep involved but its no more difficult. Cut up the base (potatoes, sweet potatoes, butternut squash) and boil until until easily pierced with a fork. Let it cool a bit (you don't have to but you will wish you had).

Then add in 3 - 4 cups of broth or stock, some diced onions and garlic, and whatever spices you prefer. Curry or paprika are great choices.

Then run the mixture in a blender until smooth (this may take several times depending on how much you made). You're done! Warm it up in a pot and enjoy.

And in case you didn't know the difference between broth and stock, here it is: Not a lot. Broth is intended to be consumed directly, so it tends to have much more sodium and other flavorings. Stock is intended for use as a base, and generally has less of both. Either way you go, look for low or reduced sodium versions.

What is your favorite home made soup? Go find out.

Oatmeail Still Tops the Superfood List

Sometimes you read something that you just can't improve on. Looks like Mom was right again.

https://getpocket.com/explore/item/oatmeal-is-still-the-world-s-best-performance-breakfast?utm_source=pocket-newtab

Most/Least Pesticide Laden Produce

 

One of the main reasons that people spend extra money buying organic foods, particularly fresh produce, is to avoid the residue left on it from the use of commercial pesticides. Both synthetic and organic pesticides have been found to have harmful health effects but at doses much higher than those typically found in fruits and vegetables. One study of 1,139 children found a 50–90% increased risk of ADHD in children with the highest urine levels of pesticides. A study of organic pesticides used in gardening found that the use of rotenone was associated with Parkinson’s disease later in life, and both synthetic and organic pesticides have been associated with increased cancer rates at higher levels in lab animals. However, no increased cancer risk has been linked to the small amounts of pesticides in produce.

Still, some of us prefer to be safe now rather than sorry later. Certainly limiting your exposure to pesticide residue in and on what you eat can do you no harm. But are all fruits and vegetables equal? Do some tend to carry higher amounts to your plate than others? It turns out the answer is yes. 

Here are ten foods that seem to have especially high levels of pesticide residues and ten that have very little. For a longer list, you can look here.

Most Contaminated Fruits and Vegetables

1. Strawberries
2. Apples
3. Nectarines
4. Peaches
5. Celery
6. Grapes
7. Cherries
8. Spinach
9. Tomatoes
10. Sweet Bell Peppers

Least Contaminated Fruits and Vegetables

1. Avocados
2. Corn
3. Pineapples
4. Cabbage
5. Sweet Peas – Frozen
6. Onions
7. Asparagus
8. Mangos
9. Papayas
10. Kiwi

If, like me, you regularly consume items on the Most list, this is not a recommendation to stop doing so. As was mentioned, the proven risk is quite small. But you may want to be sure to buy them organically grown. And as with all produce, wash it well under cool water before eating. You are probably perfectly safe buying non-organic for items on the Least list.

Holiday Weight Gain: Fact vs Fiction

We are rapidly approaching "the Holidays". Urban legend suggests that we Americans pack on lots extra pounds between Halloween and New Year's Day. The bad news is, most of us will put on some weight. The goods news is that it will likely be much less than the frenzied hype suggests. Here are some of the real facts about Holiday Weight Gain.

The average American is likely to gain about 2 pounds over the Holiday Eating Season. About half of us fall in this range. Now this is an average so there are people who will gain more, perhaps much more. But some will put on none at all.

We are very unlikely to "compensate" for too much eating and drinking with additional exercise. Controlled studies show that only about 20% of the extra calories are burned off by an extra visit to the gym.

Very few people are successful in returning to their pre-Holiday weight with a post-Holiday diet. That means that even one or 2 pounds are likely to stick with you. If you eat more and different foods at all those parties, you will have a very difficult time going cold turkey in January. If you struggled with your weight before the Holidays, it will only be more difficult afterward.

There is no need to deny yourself some overindulgence at Thanksgiving or Christmas dinner. One or two heavy eating days is not going to have a big impact on your weight. What does is a Holiday diet of booze, sweets, carbs and fat sustained for 6 or 8 weeks.

To give yourself a leg up on the season, start your day with a breakfast high in protein, enjoy the eggnog but do so moderately, and have a plan when you head to the party so far as what and how much you will wolf down. 

Two pounds or so is not really a big deal, unless it sticks with you forever.

Statin Scandal

Ok, perhaps "scandal" is a bit of a rant, but if its not then it should be. Read on and decide for yourself.

Every year, doctors write about 240 million prescriptions in the USA for statin drugs in order to lower a patient's LDL (bad) cholesterol. This amounts to over $11 Billion in sales annually. There is just one problem with this. There is little evidence to support the belief that lowering LDL levels has any effect at all on the risk of heart disease.

A new research study published in the British Medical Journal concluded that 75% of people taking statins or other LDL-lowering drugs showed no reduction in rates of death from heart disease. In many of the studies analyzed large drops in LDL levels produced no reduction in heart attacks, strokes or deaths from cardiovascular disease (CVD). The researchers noted that in the USA, CVD deaths are rising despite the heavy use of statins and generally declining levels of LDL within the overall population. The only benefit noted from taking a statin drug was for men under 75 years old who had already suffered a heart attack or stroke. In this case the benefit was from the statin's  blood thinning action, not from lowering LDL levels.

In the face of this lack of measurable benefits, statin drugs come with a number of undesirableside effects, including muscle pain and (rarely) rhabdomyolysis, liver damage, increased blood sugar levels, memory loss or confusion, headache, insomnia, dizziness and low blood platelet counts. You get all these bonuses for taking a drug that lowers LDL just as claimed but has little or no impact on your CVD risk.

I have a fiend who was placed on Crestor to reduce his high LDL levels. Within 2 years he experienced "a problem with his liver enzymes" that caused his doctor to take him off the statin. In their place the doctor suggested "diet and lifestyle changes". My question was, why was that not the FIRST suggestion instead of Plan B?

For the answer, we need to go back to 1967 and the landmark study conducted at Harvard University and published in JAMA. At that time, the dietary underpinnings of CVD were still under debate. One camp proposed that cholesterol-raising saturated fats were the cause. The other suggested that it was the inflammatory effect of sugar on arteries that was responsible. The Harvard study reviewed the link between sugar and heart disease and concluded that sugar played no role.

Only much later was it learned that the study was discreetly funded, designed and directed by the Sugar Research Foundation, a trade group representing the sugar industry. If this were the only problem it would not be an issue. Regardless of the funding source, a study can still be credible, right? But it's not.

In the 1990s, statin drugs became available and were quite successful in lowering LDL levels, so they were heavily promoted as the best preventative for heart disease. However the results of research into the relationship between LDL levels and CVD were, to be charitable, greatly exaggerated by the pharmaceutical companies conducting it.

In contrast, the authors of the BMJ study concluded that using statins to reduce the risk of CVD is "a failed strategy". "Considering that dozens of randomly controlled trials of LDL-cholesterol reduction have failed to demonstrate a consistency of benefit," they wrote, "we should question the validity of this theory." They went to to critically note that, "In most fields of science the existence of contradictory evidence usually leads to a paradigm shift or, at least, a modification of the theory in question, but in this case the contradictory evidence has been largely ignored."

So then if LDL cholesterol is not the culprit, what is? 

So far, the best predictor of future CVD is insulin resistance, which has been show in research by Dr. Gerald Raven of Standford University to dramatically increase the risk of CVD. If this is true, the biggest threat to your heart is not saturated fats but... sugar. 

Now this in no way suggests that saturated fats are healthy or good for you. They are significant sources of cellular inflammation, which is a root cause of many chronic health issues. But it does suggest that taking statin drugs for heart health benefits nobody by the pharmaceutical companies that produce them.

If you are presently taking a statin to lower your LDL cholesterol, DO NOT stop taking them suddenly. But DO start doing your own research into the risks and benefits for you and then have a conversation with your doctor about it.

(On Monday I will discuss insulin resistance in more detail and suggest some dietary and lifestyle approaches you can adopt to address it.)

Dementia Patients Overprescribed Unnecessary Drugs

 

Donovan Maust, MD, a geriatric psychiatrist at the University of Michigan in Ann Arbor, recently published a study in JAMA that concluded that nearly three quarters of dementia patients had been prescribed antidepressants, opioid pain medications, anxiety drugs or antipsychotics despite "the lack of evidence that they actually ease the dementia-related behavior problems that often prompt a doctor's prescription in patients with Alzheimer's disease and related disorders". Worse, many of these drugs "have been linked to worse cognitive symptoms in old adults". That is in addition to the increased risk from unintended side effects and drug interactions.

None of the drug classes studied has received U.S. Food and Drug Administration approval for use in dementia, and Maust says that evidence supporting their off-label use is slim. But all of the drugs are associated with special risks to people in their 60s and older, including falls or dependence that could lead to withdrawal.

If someone you care for has dementia, do them a favor and keep a list of all the prescription drugs that they are taking. Ask a doctor or pharmacist what symptoms each drug is intended to alleviate and also about its proven effectiveness for those specific symptoms. These are vulnerable people who often cannot do this for themselves.

 

 

Is There an Anti-inflammation Diet?

Not really. There just is no magic diet that will drastically reduce the chronic cellular inflammation that is at the root of much of the cancer, heart disease, diabetes, allergies and arthritis that cause us so much suffering. But that does not mean that diet and lifestyle have no effect - for good or ill.

In a study conducted at Emory University, a diet consisting of diverse fruits and vegetables (surprise, right?) was associated with lower levels of inflammation, while a more typical diet high in processed foods was associated with higher levels. Regular physical activity (who would have thought it!) was also associated with lower levels, while obesity, smoking and excessive alcohol consumption (more than 1 drink a day according to the latest guidelines) was associated with higher inflammation levels.

The study concluded that adding or removing any one component of the healthier diet and lifestyle did not have any major impact on the results, suggesting that it is the broad pattern of diet and lifestyle that was important rather than trying to focus on any one food or activity. (Which is how we got this way in the first place.) The best approach is to eat more anti-iflammatory foods while reducing those that tend to cause inflammation (they actually paid people to conclude that!).

In order to help people make those adjustments, the study authors developed a scoring system to rate various foods and activities according to their impact on raising or lowering inflammation.

The bottom line is that there is really not any special diet or routine that you can try for a while that will seriously reverse years of poor eating and limited physical activity. It is a lifestyle problem, and creating a healthy lifestyle is the solution to this, as it is to so many other health problems.

Five Foods that Support Immune System Health

 

In today's COVID-19 world, supplements and foods that supposedly support, boost, enhance, strengthen or otherwise buff up your immune system are everywhere. Can you say "Once in a Lifetime Marketing Opportunity"? Do any of them actually do you any good?

Well, yes. And no.

The actual science suggests that the way to keep your immune system strong and functioning effectively is - get ready for this - eating a healthy, balanced diet, plenty of moderate exercise, getting a good night's sleep most nights and managing your stress level. This does not mean that certain foods can not help you get the job done. Just don't expect them or a supplement to make any real difference absent the lifestyle steps listed above.

Currently, no research supports the use of any supplement to strengthen the human immune system (systems, really), let alone to protect against COVID-19 specifically. But you can add any of the following foods to your diet to help make sure you are giving your immune functions all the ingredients that they need to do their job.

1. Garlic
     Garlic has been used in folk medicine for centuries for its mild
     anti-biotic properties. There is some evidence that it can modestly
     boost the number of virus-fighting T-cells in your blood and the
     sulfer in garlic can aid your ability to absorb zinc, long used as
     a cold preventative. Plus, it makes so many dishes taste better!

2. Onions
     Cousins of garlic, onions are loaded with key nutrients that your
     immune system requires like zinc, Vitamin C and selenium. They
     are also potent sources of flavenoid antioxidants. And like their
     cousin, tossing them into a recipe is nearly always tasty too.

3. Citrus Fruits
     Almost all citrus fruits are very high in vitamin C and with the wide
     variety there is to choose from it is easy to fit them into your
     diet. Beside Vitamin C they are also rich in other vitamins and
     minerals that your body needs to work properly, including B
     vitamins, potassium and magnesium.

4. Spinach
     Come on, put on your Big Boy Pants and revisit this nutritional
     powerhouse. I know you hated it as a kid, but that was then and
     this is now. Spinach packs a myriad of of antioxidants, beta-
     carotene, iron, folate, Vitamin K, magnesium and calcium. You
     can eat it raw or cooked and toss it into salads, egg dishes, soups
     and stews. Buy it frozen and already chopped - its just as good
     for you and super convenient.

5. Poultry
     Yes, poultry. I bet you didn't expect to find that on this list. It is
     high in protein and Vitamin B6, which is important for the
     creation of new red blood cells. Chicken soup has long been
     touted for colds and with good reason.

For a more extensive list of immune supporting foods, you can look here.