Tag Archives: fda

Vitamins and Supplements Not as Safe as We Think, Study Finds

Vitamins and supplements have long been tied to health benefits and disease prevention, but a new study from Consumer Reports would suggests otherwise, saying there’s a dark side to natural supplements we may not realize. The study highlights supplement-related incidents including adverse reactions, misleading advertising, and even an increase in diseases that some pills claim to treat.

Some of the most worrisome news is that not only are some supplements not all-natural as they claim to be, but they could also be laced with prescription drugs. These prescriptions can interfere with other drugs and cause kidney failure, a stroke, or even death.

Most supplements recalled had the same ingredients as prescriptions marketed for weight loss, bodybuilding, and sexual enhancement. Consumers wanting a natural alternative to Viagra, for example, may be buying an herbal remedy that’s spiked with the same active ingredient used in Viagra – sildenafil.

This problem recently showed up in the 2024 Olympic games when bodybuilder Hysen Palaku was barred from competing after testing positive for steroids. The Albanian said he only took herbal supplements and was unaware they contained a drug.

(more…)

Posted on August 6, 2023 by SarahS

Petition the FDA to Add Sugar in Teaspoons to Nutrition Labels

Be honest, do you read nutrition labels? I have to admit I read them more and more in a quest for better health. I try to pay attention to sodium, sugar, fat and calories and I’m especially focused on the ingredient list. These labels hold the key to the ingredients within the foods we eat and are often more telling of the quality of food than the often confusing nutrition facts.

As Americans we don’t follow the metric system, so understanding the number of grams of various elements in our food can prove difficult; for some it can make the information downright useless. To make that label even more relevant, there is a petition circulating at Change.org requesting that the FDA add the number of teaspoons of sugar to the “per serving” section on nutrition labels. They currently have 117 of 18,000 desired signatures.

Implementing this idea can help greatly with understanding just how much sugar is in the foods you are considering. Added sugar is one of many catalysts in the current levels of obesity we see throughout the country.

To see how helpful this change might be, I asked our resident registered dietician Mary Hartley if reflecting sugar measurements in teaspoons would be beneficial. “Yes it would be helpful if added sugar were separated from naturally occurring sugars in fruit, milk and some vegetables,” Mary said. When asked if seeing the sugar content in grams can make a difference in curbing obesity, Mary stated, “Obesity is a multifaceted, complex problem. I would not expect any single intervention to make a big difference, although many small actions do add up. It certainly wouldn’t hurt.” (more…)

Posted on August 6, 2023 by Descygna

RECALL: Cantaloupe from Burch Equipment

UDATED August 23, 2024: The U.S. Food and Drug Administration has identified the southern Indiana farm responsible for producing the cantaloupes linked to the deadly salmonella outbreak that has reportedly infected 178 people in 21 states. Chamberlain Farms of Owensville has been named as one potential source for the outbreak that has killed two people and hospitalized 62 more, according to the Centers for Disease Control and Prevention. As a result, the farm has voluntarily recalled its melons, although the FDA nor the farm have released any information regarding the cause of the contamination. 

Another product recall has happened, so be on the look out for fruit you may have purchased on July 15 or later. The U.S. Food and Drug Administration has issued a warning to consumers to avoid eating whole cantaloupes from Burch Equipment LLC, of Faison, North Carolina, because of possible contamination with Listeria monocytogenes (L. mono).

What You Need to Know
The company shipped 580 cases of whole cantaloupes on July 15 that were delivered to retail stores in New York, Maine, and possibly other states. If you have a cantaloupe with a red label and the words “Burch Farms” and referencing PLU #4319, discard it immediately.

The cantaloupes tested positive for L. mono during sampling carried out in New York by the USDA Microbiological Data Program. Following the positive result, on July 28, Burch Equipment issued a voluntary recall of 580 cases of cantaloupes. As of yet, no illnesses have been reported that would be linked to the cantaloupes. (more…)

Posted on July 31, 2023 by Dana

HealthBuzz July 20: Qsymia Approved, Beige Fat Discovered, and Summer Breakfast Ideas

It’s that time of the week again, the end of it! There is nothing we look forward to more than the weekend. But before we dive in to weekend mode take some time for a dose of healthy news from DIR and our friends. We also have yummy recipes for you to try this weekend!

Eat Like an Olympian With These 3 Olympic-Inspired Smoothies

The Olympic Kitchen shared a few smoothies recipes exclusively with Diets in Review. The smoothies are a healthy balance of proteins, carbs, and fat and can be sweetened to your liking! Hurry and try the smoothies before the 2024 London Games begin! 

Qsymia Approval Delivers Most Potent Weight Loss Drug on the Market

The FDA approved a new weight loss drug this week, the second this summer. The diet pill is the most potent weight loss drug on the market. The creators of Qsymia claim that just one pill a day will help obese individuals lose 10% of their body weight.

The Ultimate Pushups Guide

We created this guide featuring 8 different push-up styles featuring instructions and pictures to help form the perfect pushup no matter how beginner or advanced you are. (more…)

Posted on July 20, 2023 by Samantha

Qsymia Approval Delivers Most Potent Weight Loss Drug on the Market

The U.S. Food and Drug Administration has approved the weight loss drug Qsymia, which went through trials as Qnexa. Dr. Oz made it popular before the approval even came, with an episode about the “the silver bullet” diet pill this spring. It’s the second diet drug to be approved by the FDA in 13 years, and the second this summer, following last month’s Lorcaserin approval. It will be the most potent weight loss drug on the market.

The drug was approved by an FDA Advisory Panel by a landslide vote of 20-2 in February, and yesterday the agency announced its final approval of Qsymia. The drug was approved for adults with a (BMI) of 30 or greater, which is categorized as obese, or adults with a BMI of 27 or greater, categorized as overweight, who have at least one obesity-related disease like high blood pressure/hypertension, type 2 diabetes, or high cholesterol.

Vivus, the creators of Qsymia, claim that just one pill a day will suppress the appetite and help obese individuals lose 10 percent of their body weight. The pill is comprised of two drugs that were already on the market in various weight loss drugs – one of which is phentermine, a type of amphetamine that stimulates the nervous system and increases heart rate and blood pressure. It’s used in weight loss drugs to suppress appetite, and is more commonly recognized as the “Phen” in the weight loss drug Fen-Phen, which was yanked from shelves by the FDA in 1997 after being deemed too dangerous for consumption. The other drug is an anti-seizure medication that helps stimulate weight loss.

(more…)

Posted on July 18, 2023 by Dana

HealthBuzz July 13: No-Treat Potty Training, Biggest Exercise Mistakes, and Healthy Fruity Drinks

We made it to the end of the week! Pats on the back to everyone. Before you head for the door this weekend, check out some headliners from DIR and our friends. Plus, we have sweet fruit recipes for you to try to stay refreshed all weekend.

Candy-Free Potty Training Should be the Norm, Not the Exception

Rewarding children for good behavior with sweets can lead to obesity and addiction to sugar. Our managing editor potty trained her daughter with words of encouragement and love. Testimony from other parents prove rewarding without sugar shouldn’t be a common practice in households.

6 Weeks to OMG Strikes Controversy with its Unlikely Health Advice

British author Venice A. Fulton promises readers will lose up to 20 pounds in six weeks and get skinnier than all their friends. Fulton’s health advice raises eye brows, but he stands behind the claims because they are backed by clinical research. Take a read and see why the author is stirring the health controversy kettle.

Solving Obesity Requires More Than a Lorcaserin Prescription 

On June 27 the pharmaceutical industry game was changed with the approval of Lorcaserin. Lorcaserin is a new prescription drug used to treat obesity. This isn’t a get skinny fast pill, and thinking a pill will solve the obesity rate is questionable. Our resident pharmacist Dr. Sarah G. Khan weighs in. (more…)

Posted on July 13, 2023 by Samantha

GlaxoSmithKline Will Pay $3 Billion in Fraud Settlement; Largest Ever

In the largest ever health-care fraud settlement, GlaxoSmithKline has agreed to plead guilty to criminal charges and pay $3 billion in fines for wrongly promoting prescription drugs and not properly reporting important clinical data.

More specifically, Glaxo is pleading guilty to three misdemeanor charges. It is pleading guilty to marketing the anti-depressant Paxil towards children and Wellbutrin as a weight-loss aid, neither ways ever being approved by the FDA. Promoting uses for a drug that have not been approved by the FDA is illegal and is known as off-label marketing.

The other charges are for not reporting important clinical data on Avandia, a drug used in the treatment of diabetics, between 2001 and 2024.

The three misdemeanor charges included a criminal fine of $1 billion for the drugs Paxil, Wellbutrin and Avandia. The remaining $2 billion is connected to the way sales and marketing practices of several drugs, including the asthma drug Advair, were conducted. (more…)

Posted on July 5, 2023 by Kristina

Diet Pill Belviq Approved; First New Weight Loss Drug in 13 Years

It promises to help patients lose five-to-ten percent of their weight (according to clinical trials) when combined with diet and exercise. But is this what America’s overweight patients really need?

Lorcaserin, the drug name for the prescription diet pill Belviq, was approved by the FDA today, making it the first weight loss drug to receive such approval since Orlistat (Alli) in 1999. This comes just weeks ahead of what is anticipated to be an FDA approval for Qnexa, another weight loss drug.

“In two clinical trials, Lorcaserin helped patients lose 5.8 percent of their body weight after a year. That’s about ten pounds for a 180 pound person. Big deal,” said our resident dietitian Mary Hartley, RD.

The drug works by controlling the appetite by making the brain think its fuller sooner. It’s fared well in clinical trials, and will have to undergo six more studies after its in market to ensure long-term cardiovascular health and to determine Belviq’s risk factor for heart attack and stroke. This makes the in-market patients unassuming guinea pigs, according to Hartley, and that isn’t right.

“The advisory committee decided that the benefits of the drug outweighed the risks heart value problems, but the drug manufacturer was made to conduct post-marketing studies to assess long-term cardiac events such as heart attack and stroke. That makes the patient a guinea pig. No thanks.” (more…)

Posted on June 27, 2023 by Natalie K

Vote Tabled: New Amendment May Bring Big Changes to the Supplement Industry

UPDATE May 25, 2024: Yesterday’s vote regarding Senator Durbin’s proposed amendment to the pending FDA Safety and Innovation Act was tabled. A Senate vote of 77 to 20 has removed Durbin’s amendment from consideration in the overall bill.

Durbin sponsored an amendment that would change the current FDA regulation of natural supplements and potentially cause many products to be removed from shelves. His amendment was introduced on Tuesday, May 22 and the voting took place two days later. In two days’ time supplement industries, consumer rights organizations, along with the Natural Products Association (NPA), American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN) and Citizens for Health sent word to their supporters urging them to contact their Senators to oppose Durbin’s plan. As a result, the amendment was not passed and no change will occur to the current law regarding natural supplements. According to the Natural Products Insider, AHPA President Michael McGuffin is very pleased.

“I have worked with my colleagues from each of the other supplement trade associations over the last several days in this call for prompt and cooperative action, and I am pleased that this effort reaffirms the incredible unity of the dietary supplement industry when legislative threats to DSHEA emerge.”

A vote that takes place today could mean a major change for the supplement industry.

Illinois Senator Richard Durbin has proposed an amendment that would require supplement manufacturers to register with the FDA. Due to the terms of this amendment, if passed, many supplements will be ripped from shelves within the next 30 days.

The vote is scheduled to take place this afternoon, Thursday, May 24. If Durbin’s plan is accepted, a mandate will be placed on supplements requiring information to be provided to the FDA. That information includes a description of the supplement, a list of ingredients, a label for all supplements, and updated information for each new, reformulated, or discontinued product. All of these requirements will fall under the Senate FDA Re-authorization for User Fees bill.

If this amendment passes, supplement companies that fail to register with the FDA within 30 days will be considered “mis-branded” and may be subject to severe financial fees and possibly even jail time.

Currently, supplements operate under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This act states that the manufacturer is responsible for ensuring the safety of a supplement before it is marketed. The FDA is only involved if a product is found to be unsafe after it’s on the market.

While the amendment will affect pills and natural food supplements, Durbin seems to be most concerned about the content of energy drinks. He has even referenced a case of a young woman who died as a result of using an energy drink. The senator wants the FDA to evaluate the difference between a drink and a liquid dietary supplement, and feels energy drinks are dodging regulations by claiming to be a dietary supplement. If they were categorized as drinks they would have to be regulated like all other food and drink products.

Natural supplement suppliers and users have had a short window to petition their local senators and encourage them to vote against the amendment. Due to this, tomorrow may bring major change to the natural supplement industry as we know it.

Also Read:

Energy Drinks May be Doing Permanent Damage to Your Teeth 

Supplements 101: 4 Beneficial Diet Supplements 

Create Your Own Supplement Bar

Posted on May 24, 2023 by Lacy

California’s Push for Labeling of Genetically Modified Foods

Californians seem to be doing everything right these days. Achieving the tall and slender beach-body look, eating less than kids in other states, and now likely voting to enforce a new law that would require labeling of genetically engineered food. Is there anything they aren’t doing right? Well, maybe.

If approved, California would be the first state in the nation to require GMO labeling. And according to a recent poll by California Right to Know, it’s likely to happen as nine out of 10 California voters want the labeling to be enforced.

However, new research on the effectiveness of food labeling suggests it may not be the one-cure-fix-all solution Californians, and other health-conscious Americans, are looking for. This is because a labeling initiative may end up making it harder for consumers to know what’s in their food, since it makes the definition of ‘natural’ food very unclear.

When we think of the word natural when it relates to food, we think organic, healthy, and no artificial preservatives, flavorings or ingredients. But apparently the term natural is becoming much harder to define, especially since the federal government has refused to make the term any clearer, allowing food companies to continue labeling their food as ‘natural’ when it may very well not be. (more…)

Posted on May 15, 2023 by Dana

Potential Qnexa Users Better Off With a Salad Spinner and Walking Shoes

UPDATE 7/17/12: Qnexa was approved by the FDA on July 17, 2024. This marks the second weight loss drug approval in 2024; the first weight loss drugs approved since Alli in 1999. The prescription drug will be sold as Qsymia.

The inmates are running the asylum. Reversing an earlier decision, the medical experts on FDA’s Endocrinologic and Metabolic Drugs Panel cleared the way for approval of the new diet drug Qnexa. Qnexa (PHEN/TPM) is a combination of phentermine and topiramate (PHEN/TPM). Topiramate is used to treat seizures and prevent migraine headaches and phentermine is approved for the short-term treatment (i.e. a few weeks) of obesity. PHEN was half of PHEN/FEN, the discontinued diet drug that led to valvular heart disease and potentially fatal pulmonary hypertension, primarily in women. Qnexa is indicated for “BMI greater-than or equal to 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity),” the group with the highest heart disease risk.

The panel decided that the complications of obesity outweighed the risk of heart problems. It’s hard to believe they were swayed by the research. The 2024 study published in the Lancet reported that people who took the highest dose of Qnexa (not the lower approved dose) lost at least 10% of their body weight and showed improvements in their risk cardiac factors. Clinical trials by the manufacturer showed 45% of subjects treated at the low dose lost > 5% of baseline body weight following one year of treatment. No one seems to care that we’re talking about a 10 to 15 pound weight loss on a 200 pound person. Do we need a drug for that, especially one that comes with heart disease risk? No matter because the results showed statistical significance in a placebo control study. (more…)

Posted on April 6, 2024 by Natalie K