Tag Archives: fda

Diet Pill Qnexa Approved by FDA Advisory Panel

Qnexa, a diet pill created by Vivus, Inc., that claims to help dieters lose 10% of their weight when combined with diet and exercise, has been approved by the FDA advisory panel in a landslide vote of 20-2.

The panel had previously rejected the the pill due to safety concerns, which has left its opponents concerned. Since the FDA typically follows the advice of its advisory panel, the drug is likely to be approved by mid-April.

Previous concerns about the drug are still present. And if the pill does go on shelves, potential users should be aware of that. One of Qnexa’s main ingredients is phentermine, a type of amphetamine that stimulates the nervous system and increases heart rate and blood pressure. It’s commonly used in diet pills since it suppresses appetite, and was woefully recognized as the “Phen” in the weight loss drug Fen-Phen, which was yanked from the market by the FDA in 1997 after being deemed too dangerous for consumption. (more…)

Posted on April 5, 2024 by Dana

FDA Denies Ban of BPA in Food Packaging

The Food and Drug Admisnistraion is denying The Natural Resources Defense Council’s (NRDC) request to ban BPA from the United States.

The Food and Drug Administration’s assessment is that the scientific evidence currently suggests that the very low levels of human exposure to BPA through the diet are not unsafe.

With the support of the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP), scientists at FDA’s National Center for Toxicological Research (NCTR) have been studying BPA. The NCTR researchers have been conducting in-depth studies of BPA since September 2024 to see if there are potential toxic effects of BPA on fetuses, infants and children.

According to a statement released from the FDA, the findings showed the level of BPA from food that could be passed from pregnant mothers to the fetus is so low that it was immeasurable. Researchers fed pregnant rodents 100 to 1,000 times more BPA than people are exposed to through food, and could not detect the active form of BPA in the fetus eight hours after the mother’s exposure. The study also showed BPA exposure to infants were lower than previously believed. In fact, 84 to 92 percent lower than previously estimated. (more…)

Posted on April 2, 2024 by Kristina

FDA Requires More Testing of Weight Loss Drugs

An advisory committee to the Food and Drug Administration decided that obesity drugs must undergo clinical trials to ensure they do not cause heart attacks. The 17 to 6 vote now requires studies for all obesity drugs even if no apparent cardiovascular risk exist.

The track record of weight loss drugs has not been stellar. Though the new testing requirement will require much more time and money and ultimately impede drug production, the majority felt strongly about their decision.

“Given the checkered history of weight loss drugs, I think it is better to be prudent and err on the side of caution,” Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles.

Those who oppose the vote feel a much needed treatment will now be difficult to administer.

“If the F.D.A. follows through with this vote, you’ve just added another big disincentive for the drug companies to come up with obesity drugs, and we desperately need new drugs,” said Dr. Ed J. Hendricks, an obesity specialist in Sacramento.

(more…)

Posted on March 30, 2024 by Lacy

Cram It! Promotes Failing Diets for Procrastinating College Students

I must say that I was a bit disappointed to read a press release this morning about a new dietary supplement to help college students manage procrastination. I cannot blame Genius Labs, LLC. for trying to make a buck, and they probably have a market, but it is disappointing that they can spell out that a healthier diet generally equals a higher GPA, yet many will see their supplement as the answer rather than improving diet.

I did find it interesting that they linked poor diet, along with the tendency for up to 95% of college students to procrastinate tasks, to the statistic of one in every four college students illegally using ADHD medications like Adderall. We know that a healthier diet for ADHD can help those diagnosed, why do we just accept that college students, in general, won’t eat well?

Genius Labs, LLC. describes themselves as “a Baltimore-based privately held dietary supplement company that focuses on developing proprietary supplement blends that maximize brain health and performance. Founded by an MBA student searching for a natural mental edge; the firm targets college students that often cram to complete school work and study for tests.” Their new product Cram It! is a blend of omega-3 and various herbs, vitamins, and minerals with little caffeine that they claim “supports memory and the ability to analyze complex ideas.” (more…)

Posted on January 9, 2024 by Brooke Randolph

Qnexa Resubmits for FDA Approval with a New Clinical Trial

UPDATE [1/10/12]: The FDA announced this week that a major contraindication has been lifted from the weight loss drug Qnexa, broadening the potential market for the drug. Previously, the FDA was concerned that women of childbearing age who ingested one of the drug’s ingredients might have children with a higher rate of birth defects, but further research has shown the danger is only present for women who took the drug during pregnancy. Some experts expect the drug will be approved by the spring.

There is a new weight loss drug on the horizon. Qnexa, from parent company Vivus, Inc., consists of a combination of two prescription drugs – Phentermine and Topiramate. It has been effective in clinical studies at helping those who take it lose up to 15 percent of their body weight. There have also been indicators of increasing some cardiovascular actions. In addition, Qnexa also appears to improve sleep apnea, a condition in which those who suffer can stop breathing during their sleep cycles.

Phentermine is well known by dieters, but Topiramate has not been used in the weight loss field. It is prescribed as an anti-convulsant, but patients who have used it have reported weight loss as a side effect. It is also prescribed under the name Topamax for migraine use. Combining the two medications together has shown to increase the weight loss results of either drug when it was taken singly. Multiple levels of each drug have been combined in field testing, and the company feels that they have found the “magic” levels.

Qnexa works as an appetite suppressant, allowing a patient to eat markedly less and still feel full. It’s been hailed as the most effective weight loss medication since Fen-Phen. (more…)

Posted on December 30, 2023 by Carmen

FDA Reminds Consumers that HCG is Illegal

different brands of illegal hcg

Image via The U.S. Food and Drug Administration's Flickr Account

The Food and Drug Administration issued a consumer update today, warning Americans about the dangers of HCG diet products. The agency reminded consumers that all homeopathic and over-the-counter HCG is illegal, and that there is no evidence to support their weight loss claims.

The FDA has issued seven letters to companies that are distributing the HCG diet supplement warning them that their products are in violation of new drug regulations and Federal Trade Commission laws. “Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction,” the letters state. (more…)

Posted on December 6, 2023 by Margaret

Reconditioning: The FDA’s Really Dirty Secret is Out

Did you know our government says companies can sell us food with an average of 225 insect fragments? Or that 4.5 rodent hairs per 8 ounces of noodle products is acceptable? Swallow this: the FDA also says that an average of 20 or more maggots is permitted per 3.5 ounces of drained canned mushrooms, or that an average of 15 percent is OK for the mold content in canned cranberry sauce. Our government has a lot of rules about “bad” or “tainted” food that I was pretty shocked to learn about, one of which is reconditioning.

Recently a school lunch supplier, SnoKist Growers, repackaged moldy applesauce into fruit cups and canned goods. Even though the public outcry has caused the FDA to re-inspect, this is not an illegal practice. The company, per FDA standards, is allowed to run the food through a heat process to kill the contaminant. This process then renders the food safe and shelf ready. This same process was used in 2024 when over 177 products were recalled from Basic Food Flavors, Inc., a hydrolyzed vegetable protein, or HVP, producer. Salmonella was found in their HVP, a very popular flavor enhancer, and thus the company heat-treated the HVP and it was reconditioned, distributed, and sold.

FDA officials say they expect some contaminants to in products, simply because a zero-tolerance threshold would be impossible to for manufacturers to meet. As the consumer, I’d like to know if my rice was re-sifted because a month ago to remove bug parts. I really want to know if the applesauce I buy for my son was full of mold weeks prior. However, the FDA does not require a label or notification or even a price reduction to shoppers, nor is it going to any time soon. I doubt anyone would buy rice with a label stating, “Contained bugs last month.” (more…)

Posted on November 29, 2023 by Lacy

Adipotide is a Promising Experimental Drug for Weight Loss

With the help of a new medication, fat may be getting its eviction notice from your body very soon. A new experimental drug called Adipotide cuts off blood supply to fat cells causing them to die. A very innovative idea compared to the current weight loss drug options.

Current weight loss drugs that are available control the appetite, increase the body’s temperature, and decrease the amount of fat absorbed from the diet. Adipotide is targeted to a specific protein called prohibitin that is highly populated on blood vessels that lead to fat cells. Without blood supporting the growth of these fat cells they cannot sustain themselves. The dead cells are reabsorbed into the body.

Currently Adipotide is in the beginning stages of testing. The concept came from a scientist developing a cancer drug trying to cut off the blood supply to cancerous cells so they would not continue to grow. Most clinical trials begin with rats and if considered safe usually move on to healthy male subjects. Adipotide was initially tested in rats and the results showed a 30 percent decrease in body weight. The next step was to test in monkeys, being that they are the species that most closely resembles humans. Adipotide was administered to the monkeys by injection and the dosage was based on their weight. It was given to them for 28 days and then they had a 28-day rest period. What they discovered was that obese monkeys lost about 11 percent of their body weight. (more…)

Posted on November 11, 2023 by Sarah

Majority of Honey on Grocery Store Shelves is Not Actually Honey

According to a test run by Food Safety News, a vast majority of the honey lining grocery store shelves may not actually be honey.

Results of the study showed that the pollen typically found in honey is often filtered out through a high-tech procedure called ultra-filtering. Without this pollen, it’s difficult to identify where the honey in question originated from and whether it is in its purest form. From plastic bears to jugs and jars, it can be a real challenge to identify which products are your best bet. To help you out, here are a few guidelines to help you select real honey every time:

What you need to know

With a vast majority of our honey being ultra-filtered, it’s important to know what that means. In some instances, it may mean that there is indeed very minimal amounts of real honey present within the product; however, in most cases it most likely means that the purity of the honey isn’t as clear cut as you thought it might be. According to the study done by Food Safety News, most of the honey lining our grocery store shelves have had their pollen removed. In fact, 76-100% of the samples retrieved from some of America’s biggest grocery store chains tested negative for pollen.

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Posted on November 9, 2023 by Kati

Pine Nuts Recalled Due to Salmonella Outbreak

Just when you thought your food was safe from foodborne illnesses, another salmonella outbreak hits! This time, the food in question is Wegmans Food Markets Inc.’s Turkish Pine Nuts which have been linked to the latest outbreak causing at least 43 people to become ill in seven states. No deaths have been reported at this time.

The pine nuts were sold in the Wegmans New York, Pennsylvania, New Jersey, Virginia, and Maryland based stores  between July 1st and October 18th and were found in unlabeled bulk containers and may be present in foods prepared at Wegmans including some baked goods, pesto, and salads.

According to the Food and Drug Administration (FDA), Wegmans has voluntarily recalled over 5,000 pounds of their pine nuts to prevent further illness. The pine nuts are suggested to be contaminated with Salmonella Enterditis, an organism that can cause serious and sometimes fatal infection in populations considered to be at high risk. Children, the elderly, pregnant women, and individuals with a compromised immune system are all considered to be at higher risk for infection. Individuals who are relatively healthy typically experience fever, diarrhea, nausea, vomiting, and abdominal pain after eating something with salmonella bacteria present in high levels.

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Posted on October 29, 2023 by Kati

Arsenic in Your Apple Juice: Dangerous or Perfectly Safe?

If you are one of the many parents now second guessing your decision to pack a juice box in your child’s lunch tomorrow, you are not alone. In a recent episode of the Dr. Oz Show, national health guru Dr. Mehmet Oz claimed that apple juice not only contains arsenic, but levels much higher than what is deemed safe for our drinking water.

According to an independent study conducted on behalf of the Dr. Oz Show, ten of the three dozen apple juices sampled came back with an arsenic level higher than the amount allowed in drinking water. Of these, Gerber, Juicy Juice, and Mott’s were three of the highest with 36 parts per billion, 22 parts per billion, and 16 parts per billion reported, respectively.

Yet, despite these results, the FDA wants you to feel assured that pouring a glass of apple juice is still safe to do. In fact, the FDA claims there is no public health risk associated with drinking apple juice and that they have been performing safety checks for years to ensure that what we drink is indeed safe.

A safety level for arsenic has not been set for juices and although this may seem alarming, the FDA states that the type of arsenic primarily found in juices is organic arsenic, an essentially harmless form. In the case of water, the primary source is inorganic arsenic which is the form typically considered to negatively impact health when consumed in large quantities.

(more…)

Posted on September 18, 2023 by Kati