Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Oct 23, 2015

Vitamin C Myth

Thought it might be worth replaying this one as this is the beginning of the cold and flu season.

Hundreds of studies have now concluded that vitamin C does not treat the common cold. The results of many studies of various types, involving hundreds of thousands of people from around the world have all arrived at the same conclusion - vitamin C has no effect to prevent or cure colds or cancer.

The FDA, the American Academy of Pediatrics, the American Medical Association, the American Dietetic Association, the Center for Human Nutrition at the Johns Hopkins Bloomberg School of Public Health, and the Department of Health and Human Services do not recommend supplemental vitamin C for the prevention or treatment of colds. Vitamin C does have other benefits and the studies did not say vitamin C is bad for you, it just does not provide the cancer and common cold remedies claimed.

Mar 13, 2015

FDA Terms Defined

Although the FDA has definitions for terms like reduced sugar, no added sugar, and sugar free, companies sometimes come up with marketing lingo that is just made up. One of those terms is lightly sweetened, which is not defined by the FDA. “Whether Kellogg’s Frosted Mini-Wheats Bite Size is “lightly sweetened” should be determined by federal rules, not the marketing executives of a manufacturer,” according to a CSPI report from 2010.

Cholesterol free does not mean no cholesterol. Cholesterol-free products must contain less than 2 mg per serving while low-cholesterol products contain 20 mg or less per serving. Foods that say reduced or less cholesterol need to have at least 25% less than comparable products. Cholesterol is made by the liver, so only animal products like meat, dairy, eggs, and butter can contain it. If a plant-based product, such as corn oil touts its cholesterol-free status, there is no benefit compared to other vegetable oils, which also do not contain it.

Sugar free does not mean a product has fewer calories than the regular version; in fact it may have more calories. (Food makers are supposed to tell us if a product is not low-cal). Sugar-free products have less than 0.5 grams of sugars per serving, but they still contain calories and carbohydrates from other sources. These products often contain sugar alcohols, which are lower in calories (roughly 2 calories per gram, compared to 4 per gram for sugar). We need to compare labels to see if the sugar-free version is any better than the regular version. (Common sugar alcohols are mannitol, xylitol, or sorbitol).

Products that say trans fat free or no trans fat can contain less than 0.5 grams per serving. If a product says 0 trans fat on it, it may not be zero. If you have two servings, then you may get a good amount added to your diet. Check for words on the ingredient list such as hydrogenated oils and shortening, which mean trans fat is still present.

Gluten is a protein found in grains like wheat or rye and can cause problems for those with celiac disease or gluten intolerance. Gluten-free products are becoming easier to find, which is great for those with Celiac Disease (less than 1% of the population). For the other 99% of us there is no advantage to buying them. In fact, gluten-free whole grains may have less fiber than the regular version. Unless you have metabolic problems, gluten-free products do not help you lose weight and are not necessarily good for you, but because it’s a buzz word, it is put on packages.

Feb 27, 2015

BPA Update

More good news. The FDA has reached a conclusion about BPA, the chemical that first made consumers worried about plastics that could act like hormones. Late in 2014, the agency issued a statement reiterating its position that products made with BPA are safe.

Aug 8, 2014

Gluten Free Finally Defined

The FDA finally passed a rule about what it means to be 'gluten free'. "A gluten-free claim means the food contains less than 20 parts per million of gluten, the protein found in grains such as wheat, barley and rye."

The three million, roughly .008% of Americans diagnosed with celiac disease are at risk of nutritional deficiencies, infertility, and intestinal cancer if they do not follow a strict gluten-free diet.

The rules do not apply to restaurants, although the FDA was urging them to comply. The agency also warned consumers that some products labeled gluten-free that do not meet the new standards may still be on the shelves.

Last year, gluten-free products accounted for more than $10.5 billion in sales in what has become an overblown fad for many people, for which gluten free may be more harmful to them.

Oct 11, 2013

New Toothbrush

It has been a long time since toothbrushes have changed. This interesting personally tailored brush, called the Blizzident is 3D printed to order and claims to clean your teeth in six seconds. The Company does have FDA approval for materials and production, but toothbrushes are FDA Class 1 devices and therefore generally do not need an FDA approval.

It looks almost like a set of dentures and has 400 bristles in a mold of a person's mouth. By biting down on the mouthpiece and grinding on it, the 45-degree angled bristles are supposed to clean your teeth in six seconds.

There are also inter-dental bristles that get between teeth. The Blizzident comes with slits where dental floss can be inserted to clean between teeth and the handle has a container for the dental floss. In the middle there is also a tongue scraper and brush so you clean your tongue at the same time.

The toothbrush is tailored to a person's mouth through either a dental impression or a dental scan performed by a dentist. The 3D scan can be uploaded to Blizzident's site, where it is used to make the toothbrush with a 3D printer. The first Blizzident brush costs $299 and recommended annual replacement brushes sell for $159. The company also offers to refurbish a brush by replacing the bristles for $89. Here is a LINK to the site. Wow, personally tailored low tech and high tech in one package.

Sep 28, 2013

FDA Food Label Folly

The US FDA uses common words to mean something different. FDA evaluates certain terms with reference to a typical portion size known as an RACC (Reference Amounts Customarily Consumed). An RACC of eggnog, for example, is ½ cup. For croutons, it’s 7 grams, and for scrambled eggs, 100 grams. Many labels use artificially low or high portion size to reduce or increase the amount of calories, fat, etc. perceived by the consumer.

Imitation - A food only has to be labeled as “imitation” if it has a lower amount of protein or some other essential nutrient than the food it’s trying to look like.

Free -  To be labeled “free” of calories, the food must have less than 5 per RACC. For fat and sugar, less than .5 grams. For sodium, less than 5 milligrams. Also, the food must somehow be processed to be “free” of those things in order to get the simple “free” label. You can not have “fat free lettuce,” only “lettuce, a fat free food.”

Low - Low is also defined with respect to set portion sizes and varies with whether it refers to calories, fat, or sodium. For fat it’s less than 3 grams. For calories, it’s less than 40, unless it is a prepared meal, in which case it’s 120 per 100 grams.

Reduced/less - Sometimes manufacturers want to make a relational claim about a food—not just that it’s “low” in some substance, but lower than it usually is (which may mean it doesn't meet the standard for “low”). Relational claims are evaluated with respect to a reference food. A reference food should be the same type of food, as yogurt vs. yogurt. The “reduced” substance must be less than 25 percent of what it is in the reference food.

Light/lite - This is also evaluated with respect to a reference food, and a rather complicated set of conditions is taken into account for different substances. For example, if a “light” product has more than half of its calories from fat, the fat must be reduced by half per reference serving amount. If less than half its calories come from fat, it can be “light” if the calories per serving are reduced by 1/3. Sometimes foods that meet “low” requirements can also be labeled as “light.”

High - High means that the food has 20 percent or more of the recommended daily value for that nutrient per reference serving.

Good Source - “Good source of” is a little lower than “high.” A food with this label should have 10 to 19 percent of the recommended daily value.

 Lean - “Lean” applies to seafoods or meats that have less than combined specified levels of fat, saturated fat, and cholesterol (10g, 4.5g, and 95mg, respectively).

Natural - The FDA has not established an official definition, but endorses the general understanding that it implies nothing artificial or synthetic has been added that would not normally be expected to be added.

Aug 21, 2012

Smarter Pills

The Food and Drug Administration has just approved a device that is integrated into pills and let’s doctors know when patients take their medicine and when they don’t.

The device, made by Proteus Digital Health, is a silicon chip about the size of a sand particle. With no battery and no sensor, it is powered by the body itself. The chip contains small amounts of copper and magnesium. After being ingested the chip will interact with digestive juices to produce a voltage that can be read from the surface of the skin through a detector patch, which then sends a signal via mobile phone to inform the doctor that the pill has been taken.

Sensors on the chip also detect heart rate and can estimate the patient’s amount of physical activity. It will allow doctors to better assess if a person is responding to a given dose, or if that dose needs to be adjusted.

It has been in clinical trials since 2009, but currently the FDA has only approved the chip for placebo pills, which were used in trials showing the chip to be safe and highly accurate. Proteus hopes to gain approval to use the digestible chip with other medicines. Andrew Thompson, chief executive of Proteus, says the chip has already been tested with treatments for tuberculosis, mental health, heart failure, hypertension, and diabetes.

The company is currently working with makers of metformin, a drug used to treat type 2 diabetes and the most commonly prescribed drug in the world. The company also plans on adding a wireless glucose meter to their device so that dosage amount and frequency can be correlated with changes in blood glucose levels.

Aug 1, 2012

Scratch Remedies

Most folks under 30 have never heard of using the relatively painless Mercurochrome in lieu of that nasty stinging Iodine. It stained your flesh pinkish-red. The FDA put limitations on the sale of Mercurochrome in 1998 and stated that it was no longer considered 'Generally Recognized As Safe' over-the-counter product. The main active ingredient in Mercurochrome is mercury.

Speaking of Iodine, it burned like fire when applied to an open wound, because it had an alcohol base. Many doctors today use a water-based iodine as an antiseptic, as it has one of the broadest germ-killing spectrums. This old school remedy is rarely found in home first aid kits anymore. Alas, change comes too late for some of us.

Jun 15, 2012

Blue Raspberry

Do you know why some candy makers color their concoctions? Cherry, strawberry, raspberry and watermelon all lend themselves to the color red, and if any two of those flavors were in the same pack, they had to be distinguishable by color.

At first, the problem was solved by making cherry and strawberry slightly different shades of red. Watermelon pops were often made a lighter pink-red, and raspberry ones a dark wine-red. Scientists soon found out, though, that the most inexpensive and widely available dye for this deep red, Amaranth, or Red No. 2, provoked severe reactions, and was deemed a possible carcinogen and banned by the FDA.

The ice pop folks had access to blue dye, but no flavors that needed it. It was just an extra color sitting around, so they started to marry the flavor of  blue raspberry, with the bright blue synthetic food coloring Brilliant Blue, or Blue No. 1).

Blue raspberry flavor is a now common flavoring for candy, snack foods, sweet syrups and soft drinks. It is more often used in the United States and originates from Rubus leucodermis, or Blue Raspberry for the blue-black color of its fruit. This species is also related to the black raspberry. Of course, all of this has nothing to do with giving someone the raspberries, which term, by the way, is used over much of the globe or a Bronx cheer as many in the US call it.

Jun 8, 2011

FDA Definitions

Food labels were once meant to make things perfectly clear, so we could make good food buying decisions. However, like most governmental regulations absolute rules become quickly obfuscated. The "per serving" is the thing to watch as many manufacturers make serving size humorously low to get a better rating.

"Low Fat" can mean there's up to 3 grams of fat per serving. "Fat Free" can have 0.5 grams and still count.

"Light" can mean a number of things, from the literal (the color) to the more concrete (50% the fat of plain-label), but it can also be used to mean simply "less" calories, without any actual figures. "Low Calorie," on the other hand, must have 40 calories or less per serving, and "Fewer Calories" actually means the product must have at least 25% less calories per serving.

The term "Light" used on package labeling has absolutely nothing to do with fat, sugar, or anything else. If a product "has been a long history of use of the term," then it can keep using it regardless of nutritional content.

Any product with "organic" on its packaging or display materials must contain at least 70 percent organic ingredients. "100 Percent Organic" products must show an ingredient list, the name and address of the handler (bottler, distributor, importer, manufacturer, packer, processor) of the finished product, and the name and seal of the organic certifier. These products should contain no chemicals, additives, synthetics, pesticides or genetically engineered substances.

"USDA Organic" products must contain at least 95 percent organic ingredients. The label must contain a list that identifies the organic, as well as the non-organic, ingredients in the product, and the name of the organic certifier.

"Made With Organic" products must contain at least 70 percent organic ingredients. The label must contain a list that identifies the organic, as well as the non-organic, ingredients in the product, along with the name of the organic certifier.

Nov 23, 2010

White Chocolate is Not Chocolate

This tidbit came up in a recent conversation and Jeff Flanagan suggested it might be a good topic for Friday Thoughts. In order to be labeled chocolate (as defined in the United States by the Food and Drug Administration) a product must also contain cocoa solids from chocolate liquor. Chocolate liquor is not real alcohol, but is the thick liquid produced when fermented, dried, and roasted cocoa beans are shelled, then ground. The chocolate liquor is the key ingredient in all of the chocolates on the market, except for white chocolate.

When the chocolate liquor is pressed, the fat can be removed from it. This fat is called cocoa butter, and it is the primary ingredient in white chocolate. In plain chocolate, the cocoa butter is re-blended with the cocoa solids from the separation process in order to make unsweetened chocolate. It may also be sweetened and blended with additional ingredients such as milk to make the chocolate confection we commonly eat.

However, with white chocolate the cocoa butter is not reunited with the cocoa powder. Instead, sugar and milk are added to create the final treat. Also, since the caffeine in chocolate is in the cocoa solids and not the cocoa butter, white chocolate does not contain any caffeine.

Since white chocolate labels are not standardized, some manufacturers market products that do not even contain cocoa butter as white chocolate. Usually, these contain vegetable oil and taste different.

The cocoa butter used to make white chocolate is a very stable fat and has a long lifespan without spoiling. It contains several natural antioxidants and it has a shelf life of several years. It is also used in other products, such as soaps, moisturizers, and other skin care products.

May 5, 2010

Good Salt

In response to the Food and Drug Administration's thoughts of regulating the amount of sodium food manufacturers can include in consumer goods, Frito-Lay is redesigning the salt molecule to make it healthier.

The salt crystals on potato chips only dissolve about 20 percent of the way on the tongue, while the center of each tiny cube-shaped crystal remains intact until after it's swallowed. Thus, most of the salt you're eating on your chips is not contributing to the taste of the chip, but it is dissolving further down your digestive tract.

The redesigned salt crystal, with more surface area, should dissolve completely on the tongue, so chips should just as salty with less salt. If they come after bacon, there will be a civil war.

Feb 25, 2010

Hot Dog Nonsense

Here is another way, to scare the public. The American Academy of Pediatrics wants foods like hot dogs to come with a warning label, not because of their nutritional risks, but because they pose a choking hazard to babies and children.

More than half of hot dogs sold in stores already have choking-prevention tips on their packages, advising parents to cut them into small pieces. The Food and Drug Administration, which has authority to recall products it considers "unfit for food," plans to review the new statement, spokeswoman Rita Chappelle says.

Here are the facts, stripped from the other numbers they use to scare us. 'Annually, up to 77 children under the age of 14 who go to the Emergency Room for choking on food, die', says the new policy statement, published online in Pediatrics (Feb 2010). It continues, 'about 17% of food-related asphyxiations are caused by hot dogs'. So 17% of 77 equals 13.09 children die each year from choking on hot dogs.

The academy would like to see foods such as hot dogs "redesigned" so their size, shape and texture make them less likely to lodge in a youngster's throat. I feel bad about 13 children dying, but to change a whole industry for that number seems a bit ludicrous. Maybe the Academy might make better use of its time solving some real childhood diseases that affect more than 13 children each year. A big weenie to the Academy!

Oct 28, 2009

Smart Choices

Speaking of sugar, do you remember a few weeks ago I posted an article about the green checkmark 'Smart Choices' logo that was supposed to indicate that the food was healthy? In my post, I wrote, "Sounds like green checks are the new green stamps, but with no value." Seems the Food and Drug Administration agrees with me and said it "could be misleading to consumers."

The food industry group is voluntarily halting promotion of its nutrition labeling program due to the regulators comments. Of course, I am sure my blog didn't help the cause either. Ha.

They launched the "Smart Choices" program in August to identify foods that meet certain nutritional standards and then highlight them for consumers with a green label on package fronts.
Smart Choices, has been criticized for handing its green seal to processed foods that are high in sugar.