Tag Archives: FDA

Despite Pleads and Warnings, FDA Approves a New and Powerful Opioid

The opioid crisis is stronger than ever. Just last year in the United States, there were 72,000 drug overdose deaths, and over 49,000 of those people died of opioid overdoses.  Despite a bill that was signed by President Trump to help tens of thousands battling opioid addictions, the FDA has approved a new opioid which is one of, if not the most, powerful opioid ever to be produced.

The drug, which is called Dsuvia, is the tablet form of sufentanil, a synthetic opioid that has been used since the 1980s. It is 10 times stronger than fentanyl, a parent drug that has often been used in hospitals. Fentanyl has been illegally produced in different ways, which has led to tens of thousands of overdose deaths in recent years.

Even though the FDA’s advisory committee approved the drug in a 10 to 3 vote, the panel’s chairman, Dr. Raeford Brown, wrote a letter to officials that expressed deep concern about allowing the drug to be used by the public.

In the letter, Dr. Brown predicted that the new opioid will lead to abuse and death within a few months of availability on the market. The letter questioned if the FDA would succeed in the enforcement of restrictions on the drug if it were to hit the market.

Dr. Scott Gottlieb, the FDA commissioner, gave the drug final approval and released a statement that defends the decision, stating that Dsuvia will only be allowed for use in hospitals and other medical settings. He also stated that the drug is ideal for serious situations and that more soldiers wounded in the battlefield would have died without the strong painkiller.

Now it is up to hospitals and the FDA to prevent this opioid from hitting the market. If they fail, it could be very bad news for addicts and families.

 

FDA Proposes Crackdown on Flavored E-cigs

There have always been jewels and diamonds in the air for Juul, the e-cigarette company that is trendy for young adults that want to look cool, just without the health problems. One problem: e-cigarettes are causing a new generation to become addicted to nicotine. On Wednesday, the FDA responded that they might take away the “jewel” from Juul.

Juul e-cigarettes may be in trouble; photo from time.com
Juul e-cigarettes may be in trouble; photo from time.com

The Food and Drug Administration (FDA) has declared the use of e-cigarettes by teenage users to be of “an epidemic proportion” and has given the makers of e-cigarettes 60 days to prove that they are able to keep their products away from minors. If not, companies like Juul will no longer be able to sell their products and they could face civil and criminal charges if they allow bulk sales through their websites.

Juul and e-cigarette companies weren’t the only ones to get the hammer on Wednesday as the FDA sent out letters to over 1100 stores across the nation, warning of what could happen if they sold e-cigarette products to minors. The FDA also issued 131 fines for selling e-cigarettes to minors, ranging from under $300 to over $10,000.

In a press briefing to reporters, the FDA’s commissioner, Dr. Scott Gottlieb, said that over 2 million students going to either middle or high school were regular users of e-cigarettes and the flavors that come with them.

While it is true that e-cigarette users inhale fewer chemicals than the normal cigarette smoker, studies show that e-cigarette users get more addicted to nicotine due to the high amounts of it found in e-cigs.

Juul wrote a statement in an email to the New York Times about the FDA’s decision, saying, “Juul Labs will work proactively with FDA in response to its request. We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.”

The FDA has also threatened to ban all flavors associated with e-cigarettes. Smoking e-cigarettes can also be called “vaping,” depending on what you believe constitutes vaping and what doesn’t.

As more information comes out about e-cigarettes, the FDA continues to place more sanctions and limits on companies like Juul. There could be a time where e-cigarettes get banned, but since the actual cigarette hasn’t been banned, then most likely the e-cig is likely here to stay.

If you are dealing with substance misuse or you know of someone here on campus dealing with substance misuse, please get in contact with SAVES, located in the lower level of Tyler Hall. You can call them at (540)-831-6031 to set up an appointment or you can walk in. All information will be kept confidential.

Genetically modified salmon receives FDA approval

The FDA has approved a fish genetically engineered to develop more rapidly than non-genetically engineered salmon, named the AquAdvantage Salmon. It’s the first GMO animal approved for human consumption in the United States.

The AquAdvantage salmon develops twice as fast as non-GM Atlantic salmon, due to the over-expression of a growth hormone. AquaBounty Technologies, the organization that made the fish, has been attempting to get it through approval for just about 20 years. The fish is an Atlantic salmon which has been genetically modified to incorporate genes from various fish, including a growth hormone gene and the promoter of an antifreeze gene.

Genetically modified salmon is now FDA approved. Graphic by Katie Gibson
Genetically modified salmon is now FDA approved. Graphic by Katie Gibson

In a statement released November 20th by AquaBounty’s CEO Ron Stotish, he said, “AquAdvantage Salmon is a game-changer that brings healthy and nutritious food to consumers in an environmentally responsible manner without damaging the ocean and other marine habitats. Using land-based aquaculture systems, this rich source of protein and other nutrients can be farmed close to major consumer markets in a more sustainable manner.”

The FDA has only agreed to AquaBounty’s present breeding and growing setup, where fish are bred in Canada on Prince Edward Island, and sterilized eggs are shipped to the highlands of Panama to be developed to market size. On the off-chance that the product takes off and the organization needs to add additional facilities, each of these would need to get approved separately. “It’s not clear that it would be a simple process by any means,” Smith says.

With the current administrative fight behind it, AquaBounty still has to win over grocery stores and customers careful about GM products. “It’s difficult to disentangle consumer’s attitudes from their understanding of the technology,” Smith says, “there are a lot of politics of [GM organisms] that might inform people’s decision-making that might not have anything to do whatsoever with the technology.”

What’s more, in light of the fact that the new product can be labeled as farmed Atlantic salmon without mention of the genetic modification, shoppers may not know they’re eating it unless sellers explicitly decline to purchase it, Smith says. Target, Trader Joe’s, and Whole Foods have stated that they weren’t going to sell, or buy, the fish.

Our favorite banned foods

It’s a common stereotype around the world that US citizens are fat and unhealthy — and that has a lot to do with our diets. Many countries have banned some of our most popular foods, from certain ingredients in your McDonald’s hamburger to your Kraft Mac n’ Cheese.

Books like Mira Calton’s Rich Food, Poor Food and other sources have spread information on what foods have been deemed unsafe by foreign governments — and why. Recently, a list of some of the top 10 forbidden ingredients has been floating around the Internet.

Artificially colored food such as Yellow 5, Red 40 and six other dyes are known as the “rainbow of risk” by the Center for Science in the Public Interest. These dyes, made from petroleum and coal tar, help enhance foods such as Fruit Loops and granola bars. They’re banned in Norway, Finland, France, Austria and the U.K.

Chicken with arsenic is banned in the European Union. Arsenic in used in chicken feed to reduce parasites, making chickens grow faster and giving their meat more color. Of course, it also gives the chicken we eat arsenic, which is known to cause lung, bladder and skin cancers.

fruit loops
“Books like Mira Calton’s Rich Food, Poor Food and other sources have spread information on what foods have been deemed unsafe by foreign governments — and why.”

 

Drinks with brominated vegetable oil (BVO) are banned in more than 100 countries. You can find bromine in PepsiCo’s Mountain Dew and carpets, where it is meant to be a flame retardent.

Breads with potassium bromateusebromated flour, which assists in breads’ rising efficiency, has been banned in Europe, Canada and China — even California declared it a carcinogen in 1991. Potassium bromate has been linked to thyroid and kidney cancers.

Frozen dinners with azodicarbonamide, a chemical that bleaches and stabilizes flour, is banned in Australia, the U.K. and most European countries. It’s found in frozen TV dinners, packaged baked goods and some breads, and in foamed items such as sneakers and yoga mats. It’s been associated with asthma.

Food preserved with BHA and BHT is banned in the U.K., Japan and many European countries, while the debate over their safety is ongoing in the US. These preservatives are added to cereal, nut mixes, gum, butter, meat and dehydrated potatoes to keep them from turning rancid.

Milk with rBGH and rBST, also known as bovine growth hormones have been linked to cancer and infertility. They have therefore been banned in Australia, New Zealand, Canada, Japan and the European Union. These synthetic hormones are given to cows and found in milk and other dairy products.

Finally, chips with Olestra or Olean, a fat substitute used in fat-free chips like Ruffles Wow, can produce cramps and leaky bowels. These ingredients are banned in the U.K. and Canada.

This list is certainly not all-inclusive and the consequences of what they may cause are overwhelming. While we rely heavily on the FDA to protect us from proven dangerous foods, we can’t forget to pay attention to the foods we eat and the ingredients they contain.

Fix the plastic problem

One of the most popular materials in our lives is also filled with dangerous chemicals that leak out into our environment: plastic. This isn’t exactly new information, particularly with celebrities like Oprah Winfrey hailing the horrors of bottled water or more and more cities banning plastic bags from being given away at stores. Even Plato’s Closet in Christiansburg will give an extra discount stamp for declining a plastic bag.

polluting
“One of the most popular materials in our lives is also filled with dangerous chemicals that leak out into our environment: plastic.”

The waste produced from plastic that isn’t or can’t be recycled takes up a sizable chunk of landfills, simply buried underground with the rest of our waste and allowed to poison that ground. While chemicals leaking from plastic into our soil and water is its own problem, the chemicals that leak into our food and so forth is also consumed by humans. The Food and Drug Administration says that amount that’s actually consumed by humans is safe; however, this only means that it probably won’t permanently harm or kill us.

Chemicals from plastic can potentially alter hormones, poison wildlife, and so forth.

However, the fact remains that most of our lives are supported by plastic. Your phone, car, grocery containers, and even the IV bag you get at the hospital are all made from plastic. For a relatively new material, it seems to be integral to our world. So how do we stop plastic from killing it?

Scientists have been trying to figure that out for years and a team of researchers from North Dakota State University have made a huge step recently. They’ve invented a new recipe of molecules that allows plastic to degrade in just three hours of direct sunlight. The new solution is based on fructose molecules and light-absorbing molecules called phototriggers that when strung together and cooled create a solid plastic. The best part? According to the team’s recently published paper in Angewandte Chemie, these molecules can then be recovered and re-used to make new plastic, which helps reduce the demand for raw materials.

Of course the whole dissolving in sunlight thing might not be ideal for many of our plastic items, such as cars or patio furniture. For cell phones and other devices which aren’t often in sunlight for prolonged amounts of time and are difficult to recycle, this material could make a huge impact on waste.  While still being tested and modified for commercial production, this new material could be the first leap in a world desperately in need of less plastic.

FDA changing labels on painkillers to curve dependance

On Sept.10, the Food and Drug Administration announced a new labeling system for prescription painkillers in an effort to deter abuse. Health care providers and patients will soon be faced with this updated labeling in the near future. Douglas Throckmorton, M.D., a deputy director in the Center for Drug Evaluation and Research at the FDA, stated, “These actions are part of the FDA’s efforts to make opioids as safe as possible for those who need them.”

Continue reading FDA changing labels on painkillers to curve dependance

From our perspective: Happy meals aren’t always so happy

Like all fast food restaurants, McDonald’s promises quality food at an affordable price. Sometimes, however, I wonder if that reasonable price should come with a disclaimer. The quality and standards of the end product should never be compromised because a company is trying to reduce costs; a factor which is being compromised more frequently in the fast food industry.

Recently, McDonald’s made a press release stating that their burgers would no longer contain “pink slime.” Pink slime is comprised mostly of ammonia and meat trimmings, according toJulie Kennel, director of Human Nutrition at Ohio State University. Ammonia is a chemical, most commonly found in household cleaners such as Windex, Mr. Clean and Pledge. If inhaled or ingested, ammonia can have potentially serious health risks including fatigue, respiratory failure, burns or corrosive bodily damage.
Why would McDonald’s have had an ammonia-based meat product in their burgers in the first place? How do we, as consumers, know what else might be lurking inside one of these burgers? McDonald’s is supposed to be a place we all know and love. Its whimsical past, including Ronald McDonald, Grimace, Mayor McCheese, Hamburglar and many others, bring back memories of colorful ball pits and happy meals. Most of us grew up loving McDonald’s and the entire “eating experience” that has been provided by the golden arches for years.
When you think of McDonald’s as a brand, you probably think of the long tradition of beloved food, iconic symbols and lovable mascots. Releasing such a bold statement, such as the removal of pink slime (seeing how most people had no idea that something so dreadful could be hiding inside of their burgers in the first place), could hurt their reputation as a hallmark company forever.
The American public should demand better quality food. In discussing what should be done to make sure no harmful chemicals or toxins are in our fast food products, I came to the conclusion that the FDA or another federally funded program should be more heavily involved in the regulation of fast food. After seeing the various articles on pink slime, would that actually entice you to go out of your way to eat at a fast food joint? McDonald’s will, and should, get heat from consumers for an extensive amount of time to come, so hopefully some good will come of this.
If the FDA mandates a higher standard for beef in fast food restaurants, then maybe we will decide that it’s safe to eat at our favorite childhood eatery again. High quality fast food matters to me. How about you?
Graphic by Ashley Kincaid.