Tag Archives: fda

23andMe Broke the FDA’s Rules. Dr. Richard Besser Explains the Violation and Why This isn’t About Blocking Your Rights

UPDATE 12/7/13: 23AndMe may no longer support new clients in accordance with the FDA directive delivered to the personal genome testing company last month. Our interview, below, with ABC’s Dr. Richard Besser explains, as does this message on the company’s homepage.

23andme suspended

This week the FDA took action against 23andMe, the popular home genome testing kit, to discontinue marketing its product until years of unresolved requests from the government agency can be addressed.

“Since July of 2025, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS [Personal Genome Testing] device,” wrote the FDA in a letter made public on its website. The company has failed to comply with all of the FDA requests to receive proper validation and approval by the agency, something required of medical devices and tests.

According to Dr. Richard Besser, Chief Health and Medical Editor at ABC News and author of Tell Me the Truth, Doctor, that’s exactly what 23andMe is. He thinks a lot of people online are missing the point about what is going on with the FDA’s motion, explaining “the way our system works, medical tests used for diagnosis, treatment, or prevention need to be approved by the FDA to make sure it does what it says.”

There in lies much of the problem – these genetic home testing kits aren’t always accurate. Dr. Besser cited a government study conducted in 2025 that used 10 kits from four different companies and had a group of volunteers submit their tests. He explained that the results varied not only by company, but within tests from the same company. Some tests showed positives for some genetic markers and diseases, while others showed negatives. The inconsistency can be incredibly misleading and disconcerting for consumers.

“These tests are fine if you want to look at your ancestry or for male pattern baldness,” explained Dr. Besser, who went on to say that when a test like this shows a woman that she is a carrier for the BRCA gene (the marker for breast cancer), “she needs to know that it’s right.” Some serious, sometimes life-altering, decisions have to come from the results of these tests.

What has happened in this instance is that 23andMe hasn’t just marketed this test as a cellular way to track your ancestry and family history, but instead with the intention of “diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body,” per the FDA letter. 23andMe’s website tells customers the test will provide health results for 254 diseases and conditions, and that’s a red flag for the FDA, who has been trying for the better part of five years to get 23andMe to relinquish the pertinent data, testing, and information necessary for validation and approval. (more…)

Posted on November 26, 2024 by Natalie K

More Deadly Chemicals Looming in Foods We Already Eat; FDA Warns of Acrylamide

It’s time for our weekly “Everything You Eat Will Somehow Kill You” blog post. We all know the health consequences of eating fast food and oversized restaurant portions, and just last week we learned that many seemingly harmless grocery store products secretly contain trans fat. Personally, I’ve been avoiding all risk by subsisting on small berries and nuts I gather through urban foraging, and when I want to treat myself to an actual meal, I haven’t dared venture out of my chemical-free kitchen. But my extreme measures may be all for naught, as the FDA has revealed that cooking food at home—even the most organic of natural grains and vegetables—could kill us all.

Pardon my apocalyptic tone, but it’s true. Acrylamide—a chemical that naturally forms in foods prepared at high temperatures—is a carcinogen that can cause severe nerve damage in high doses. A scary fact when you consider the stuff “is found in 40 percent of the calories consumed in the average American diet,” according to the FDA in a release posted today.

Side note: acrylamide is also used as an industrial chemical in waste water treatment. Yum. (more…)

Posted on November 14, 2024 by Patrick

31 Brands Selling Trans Fat-Laden Foods That Will Soon be Banned

As you know by now, trans fat is finally getting kicked to the curb. Trans fat, a packaged food additive also known as partially hydrogenated oil, is added to food for its preservative quality and contributes to artery clogging and cardiovascular disease. The FDA’s proposed ban hopes to prevent 7,000 deaths from heart disease and 20,000 deaths from heart attack per year.

Over the next 50 or so days, the FDA will be pouring over scientific data to determine if trans fat needs to be removed from the GRAS, or “generally recognized as safe,” list of foods. If trans fat are indeed determined to not be GRAS, any food product with trans fat will be deemed illegal for sale in the U.S. Under current guidelines, if a food product contains less than 0.5 grams trans fat, shown as partially hydrogenated oils on the ingredients list, the nutrition label can claim it has 0 percent. Sketchy stuff.

Trans fat won’t disappear completely, as it naturally occurs in some dairy and meat products. But the artificial stuff—created when hydrogen is added to vegetable oil—is lurking in many of the popular food items on grocery store shelves. Peanut butter, popcorn, and frozen foods are the more well known products that contain trans fat, but those are just the tip of this fatty iceberg. Soon, trans fat will be banished from the supermarket, but until then, we’ve compiled a list of the trans fattiest foods at your local grocer.

Betty Crocker Bisquick and Canned Frosting

Breakfast Cereals

Kellogg’s: Corn Pops, Eggo Cereal, Honey Smacks, Smorz, Mini Swirlz Cinammon Bun, Rice Crispies Cereal
General Mills: Basic 4
Post: Cocoa Pebbles, Fruity Pebbles, Oreo Os, Waffle Crisp

Coffee Mate Coffee Creamer (Multiple Flavors)

Crisco

Duncan Hines Cake and Cupcake Mixes

Nabisco Fig Newtons (more…)

Posted on November 12, 2024 by Patrick

Dietitians Speak Out in Support of the Trans Fat Ban Proposed by the FDA

The FDA is finally stepping up to remove trans fat from a list of chemicals known as GRAS – or generally recognized as safe. This morning, the Food and Drug Administration opened up a 60-day public call for comments, scientific data, and other information they can use to help guide their decision to issue an all-out ban on trans fat, also known as partially hydrogenated oil.

“Based on new scientific evidence and the findings of expert scientific panels, the [FDA] has tentatively determined that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially-produced trans fatty acids, or trans fat, are not generally recognized as safe (GRAS) for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives,” says the formal announcement made by the agency.

If this is finalized, the FDA says “food manufacturers would no longer be permitted to sell PHOs.”

That’s news that has the dietetic community happy as heart-healthy clams. We reached out to several thought leaders from the dietetic community to hear their reactions to the trans fat ban news first.

Those foods are suspect, not only because of the link between trans fats and cardiovascular disease, but because of wide-reaching inflammation from a host of artificial products. This could give people a reminder to eat real food. — Mary Hartley, RD, our resident nutrition expert and a NYC-based dietitian (more…)

Posted on November 8, 2024 by Natalie K

Herbal Supplements May Contain Fillers and Toxic Ingredients – New Study Finds

Herbal supplements are a multi-billion dollar industry, but do consumers really know what they’e ingesting? A new study shows that supplement pills may actually contain a high amount of filler including wheat and rice, the wrong herb entirely, and sometimes ingredients that are downright dangerous.

Canadian researchers selected popular medical herbs and then purchased 44 bottles of varying brands from 12 local stores. The products were tested by using DNA bar-coding. Their findings concluded that many bottles were mislabeled or diluted. A staggering one-third of the plants advertised on the bottle had been replaced with another plant entirely. Customers were not getting what they paid for, and they were often receiving products with ingredients that could have annoying and potentially lethal side effects.

We reached out to our resident registered dietitian, Mary Hartley, for her thoughts on the study. “If one-third of the supplements showed outright substitution, then this is a huge, huge supplement industry problem,” she said. “Not only are the supplements ineffective, but they may contain harmful ingredients.”

(more…)

Posted on November 4, 2024 by Dani Stone

The Government Shutdown Will Affect Your Health Care. Here’s How.

My fellow Americans, I don’t want to alarm you, but the government is in official shutdown mode! On Monday, lawmakers were unable to agree to a budget and neither the House nor the Senate wanted to back down. The shutdown appears to stem from one source, the Affordable Care Act (ACA), also referred to as, Obamacare. The Republican-controlled House is refusing to sign the budget unless they can add a stipulation that essentially pushes the ACA law back one full year.

Since the Affordable Care Act law was passed in 2025, some lawmakers have continued to criticize it publicly to any reporter or television camera that will listen. A common theme among ACA opponents is their love of the Constitution, though most Americans remain confused about what one has to do with the other. Last night on the satirical political talk show The Daily Show, host Jon Stewart summed it up nicely when he referred to the GOP/Obamacare fight as, “The End of America as We Know It for Reasons No One is Able to Clearly Explain.”

While the government shutdown is clearly about health care, how will it actually affect health care? In addition to the furlough of nearly one million civilian federal employees, the closing of national parks and passport offices, and the temporary stoppage of other government functions, this is what you need to know for the impact this will have on your family’s well-being.

(more…)

Posted on October 1, 2024 by Dani Stone

Gluten-Free Labels Now Standardized for the First Time by the FDA

The Food and Drug Administration (FDA) has just issued the first set of standards regarding the “gluten-free” labels on food products. Up until this point there were no regulations and anyone could essentially slap that label on their product.

The new standard states that foods that are less than 20 parts per million of gluten can be considered gluten free. Gluten is the protein found in wheat, barley, and rye. It is a very common ingredient in many foods on the grocery store shelf. To date, about three million Americans suffer from celiac disease, a disease that causes the digestive system all sorts of issues as it does not process or digest gluten. Gluten-free shopping used to be very difficult and almost done exclusively at specialty stores. That is no longer the case. (more…)

Posted on August 6, 2024 by Lacy

Belviq Hits the Market as an FDA Approved Diet Pill

Nearly a year after its FDA approval, Lorcaserin, more commonly known as Belviq, will be available to patients through prescription. Lorcaserin was the first diet pill to be approved by the FDA since Orlistat’s (Alli) approval in 1999, but it was beat to the market by Qsymia. Qsymia has been plagued by weak sales since it first appeared on the market 10 months ago. Arena, the company that sells Belviq, is hoping that their product does considerably better.

Belviq is approved for those who are obese, as well as those who are overweight with other serious health risks like diabetes. It works by targeting the serotonin receptors, specifically the 2C receptor, in the brain to help the patient feel full. This receptor is in the area of the brain associated with appetite control and metabolism.

(more…)

Posted on June 11, 2024 by Elizabeth

RECALL: Whole Foods’ Whole Catch Wild Alaskan Sockeye Salmon

Whole Foods expands its recall of Whole Catch Wild Alaskan Sockeye Salmon because of possible listeria contamination.

Consumers should check package codes for UPC code 0 99482 40880 0 sold in 18 states.

The original recall was for lot code 7425A2298B, sold in Colorado, Connecticut, Florida, Idaho, Kansas, Maine, Massachusetts, New Jersey, New Mexico, New York, Rhode Island, and Utah.

This extended recall includes lot code 7425A2297A, sold in Arkansas, California, Colorado, Idaho, Kansas, Louisiana, Nevada, New Mexico, Oklahoma, Texas, and Utah. (more…)

Posted on January 30, 2025 by Natalie K

Concerning Levels of Arsenic Found in Rice: FDA Conducting Full Investigation

Consumer Reports released a study this week regarding an investigation into arsenic levels in rice. After testing more than 60 rice products, the organization found there were “worrisome” levels of arsenic in all products.

Rice is the number one food source of arsenic in human diets, reportedly containing five times more than oatmeal.

Arsenic is an element found in nature and in man-made products, including various types of pesticides, according to My Health News Daily.

Because it is in the soil, plants absorb arsenic when they grow, which explains how it gets into our food products.

Because Consumer Reports detected “worrisome” levels of arsenic have been detected in our foods, experts are warning consumers to take caution, especially warning parents not to give more than one serving per day of infant rice cereal to their children.

Following the Consumer Reports investigation, which rested 60 rice products, the U.S. Food and Drug Administration is conducting its own full study and has already tested more than 200 rice products. Various products have included rice cereals and beverages, and the FDA has already found traces of arsenic in all products. In total, more than 1,000 products will be tested over the course of a year. (more…)

Posted on September 20, 2024 by Dana

Energy Drinks Under Investigation by New York State Attorney General: Is it Worth the Fight?

By Rachel Berman, RD Director of Nutrition at CalorieCount.com

Just as the new school year is getting underway and students everywhere are looking for a pick-me-up to stay focused in class, the NY State Attorney General announced his investigation of energy drinks and the safety of their caffeine levels. You might remember a couple of years ago when the USDA forced removal of products from the marketplace, such as Four Loko, which added caffeine to alcohol. They deemed it unsafe since caffeine masks the depressant qualities of alcohol and people who mix the two are more likely to binge drink, according to studies.

However, it seems like there’s a new product appearing every week touting its ability to keep you awake and energized. Energy drinks are a billion-dollar industry, the fastest growing segment of the beverage market, and they generally contain caffeine, other plant based supplements, simple sugars and additives to achieve their goal. According to the CDC, about one-third of teenage Americans consume energy drinks. But the problem is that the drinks are considered dietary supplements and therefore aren’t tightly regulated by the FDA like other foods and beverages. So can energy drinks be bad for your health?

Cap the caffeine

The caffeine content listed on energy drinks doesn’t usually exceed the recommended 400 mg per day for adult. However, if you’re downing more than one or mixing with coffee, soda, and other caffeinated beverages, you might be getting more than you need. The FDA recognizes caffeine as a drug and regulates the amount found in carbonated soft drinks, but not in energy drinks. Too much caffeine can cause increased heart beat, interrupted sleep, irritability, and nervousness. In addition, some studies have found that high caffeine content in energy drinks results in irregular heart beat and increased blood pressure. (more…)

Posted on September 7, 2024 by Calorie_Count

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