When It Comes To Medical Devices, The Process Is Different
The FDA generally uses a risk-based approach to regulating specific medical devices. That is, the higher the risk, the more likely it is to be federally approved. There are generally three tiers of devices. Class III is the highest and includes devices like infusion pumps and mechanical heart valves. They require FDA approval before they can go to the market. The manufacturers must demonstrate reasonable assurance that the devices are safe and effective at their intended uses.
Class II includes devices like dialysis machines and some kinds of catheters. The FDA clears these if they demonstrate that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval. Class I includes devices like tongue depressors, exam gloves, and elastic bandages, for example, and does not require premarket notification.
The ackee is a fruit from Jamaica that can be quite dangerous if you don’t reap it at the right time. Before harvesting, you must allow it to become ripe. Even then, you still have to exercise special care. Ackee has high hypoglycin A and B levels, which can cause comas and even death. So how do you tell when ackee is ripe?
You have to wait until the ackee fully opens naturally. Forcing measures to open an ackee can result in toxicity. Once you remove the fruit, you must extract the seeds and the reddish membrane surrounding it. Then you need to wash and cook it properly. Dispose of the water you cook it in.
The Use Of Sunscreen in Cosmetics Won’t Pass FDA Regulations
The problem with cosmetics stating that they have sunscreen is that it places them in the “drug” category, subjecting them to regulation. And there is very little evidence to prove that sunscreen in cosmetics will actually work to block the sun’s harmful UV rays. There is one exception to the rule, however. Companies may use sunscreen ingredients if they protect the product’s color, which the packaging states.
This is to protect consumers so that they don’t believe that they can use makeup alone to protect their skin when that isn’t the case. The other included ingredients could interfere with the sunscreen’s ability to do its job, thereby further decreasing its effectiveness. It’s better to add sunscreen to your makeup to achieve full protection.
We’ve all grown a little upset that countries like Canada have the Kinder Surprise chocolate eggs, a chocolate egg that has a toy inside. So why is the FDA so adamant about allowing these across the border? That’s because they consider the toys inside a choking hazard, especially when it comes to children handling these eggs.
However, it has come to recent attention that the ban stopped in 2018. Now the company packages the chocolate eggs a little differently from their Canadian counterparts to prevent children from still choking on the toys. They’re called Kinder Joy eggs and are still pretty much the same thing, just under a different name.
Another chemical that the FDA prohibits from being used within cosmetics is hexachlorophene. This is because it is capable of penetrating human skin and can lead to adverse effects. Some of these side effects include swelling, skin rash, blistering and reddening of the skin, scaly skin, and increased sensitivity to sunlight. An overdose can result in confusion, convulsions, diarrhea, dizziness, fainting, blurred vision, abdominal cramps, loss of appetite, weight loss, wheezing, and thirst.
Each product can use no more than 0.1% of hexachlorophene only if no other preservatives are safe. In addition, there can be no cosmetic products using hexachlorophene on any mucous membranes, including the lips. Any products for children cannot contain any amounts of hexachlorophene.
Bithionol is an antibacterial and an algaecide and is for the treatment of tapeworms in horses. So why would the FDA regulate its use in cosmetics? The reason is that it may cause photo contact sensitization of the skin. This is where the product has an interaction with sunlight or UV radiation and causes a reaction on the skin.
Bithiniol was originally in certain soaps and cosmetics to serve as an antiseptic until this interaction. It also helped break down any odor produced by the bacterial decomposition of organic matter on the skin. Since then, FDA has banned this ingredient. You should never use it too often, anyway. Why? Because bithiniol plus sunlight could result in serious skin disorders.
Pasteurized milk has existed for centuries. Why? Because it is the process by which people heat milk to a high temperature in order to kill any harmful bacteria that might be present. This process has made milk safer for consumption. Unpasteurized milk does not go through this process, which is why the FDA deems it unsafe.
In fact, pasteurized milk is even illegal in some states, so you’re not going to find it in many places. This has come under contention, as a group of raw milk advocates out there deem unpasteurized milk as the healthiest way to consume it. But has anyone told them that humans are the only animals that continue to drink milk into adulthood? What’s so natural about that?
You Won’t Find Chlorofluorocarbon Propellants In Cosmetics
People also call them CFCs, and the FDA banned them back in the mid-90s. This is because CFCs when released into the atmosphere, can start to burn a hole in the ozone layer. Before their ban, CFCs were used in pretty much everything, from hairspray to any aerosol products, refrigerators, and packing materials used outside of cosmetics or any other domestic consumption. This means that manufacturers must go back to the drawing board for what to put into their products.
It’s not that they’re dangerous to human health — they’re nontoxic and nonflammable — but it’s when they’re broken down in the air that creates the real problem. Inorganic chlorine is a result that eats away at the stratosphere that protects harmful radiation from reaching the Earth’s surface. Thankfully, banning CFCs in the 90s has led to the hole in the ozone layer slowly repairing itself.
The Ban On A Fish In Order To Preserve Its Numbers
The redfish is a pretty rare species of fish, so when a New Orleans chef published a recipe for its preparation back in 1980, the redfish population started to dwindle even more, to the point that the fish became endangered. This is a case of the FDA stepping to preserve the species rather than for any safety measures. To this day, redfish is banned in every state except Mississippi.
The Commerce Department stepped in in 1986 and forced redfish fisheries to close down and limit fish sales. Why? So that the numbers could increase. But even with the ban in place, most states still allow for the fishing of redfish, as long as it is for personal use only.
When you hear the word “cheese,” you probably think of delicious, shredded cheese on a taco or melted cheese on some broccoli or potatoes. But casu marzu is not a cheese you’ll likely want to put in your mouth. It’s definitely creamy, to be sure, but once you hear how it gets that consistency, you may never want to consider it ever again.
The secret to casu marzu is the presence of fly larvae. That’s right: flies are allowed to lay their eggs inside Pecorina cheese so that they can hatch into larvae and speed up the fermentation process. That’s why the cheese has such a creamy texture. What’s even worse is that you have to eat the cheese while the maggots are still alive. once they die, then the surface of the cheese is ruined. There’s a reason that casu marzu is also called “maggot cheese.”
Even foods that are FDA-approved do not have their labels and nutritional facts approved. The FDA requires specific labeling elements, such as serving sizes and nutritional content. Otherwise, the FDA doesn’t spend time inspecting labels to ensure that they need approval. The onus is left on the manufacturers themselves to comply with the requirements, and they have to ensure that any statements made on the labels are truthful and not misleading.
A lot of time would have to be spent reading every single label to ensure that they meet requirements, and the FDA has a lot to get through. They are only required to update the conditions of food labels. This is to help people make informed decisions on what they’re eating and drinking so they can choose to live a healthier lifestyle.
Would you believe that mangosteen was once missing in the United States because of the fear of Asian fruit flies? It’s a real concern that invasive species will arrive on certain fruits and vegetables. That is why the FDA has strict import rules. The FDA mostly lifted the ban. However, if there is any importation of mangosteen, they are first irradiated to ensure that any fruit flies or larvae are killed first.
So why not grow it in your own backyard? Studies prove it is complicated to cultivate outside of Southeast Asia. This is because the fruit requires a lot of humidity and high temperatures to flourish. It was also challenging to import because it spoils so easily, wasting many resources for such a coveted fruit.
You may have heard that shark fin soup is a delicacy in some Asian countries, but you’re not going to find it anywhere in the United States. That’s because the act of “shark finning” involves the removal of a shark’s fin while it is still alive and releasing it back into the ocean. This is a big no-no; despite this, the actual consumption of it isn’t illegal. But you’ll have a hard time finding any restaurant in the United States serving it.
Shark finning was outcast back in 1993 to prevent the overfishing of sharks. However, since then, the government has established new rules, and fishermen can once again bring a shark to shore with all of its fins still attached. They have permission to remove the fin, too. Keep in mind, though, that the market for shark fins doesn’t really exist in the United States, so the majority of sales come from Asian countries.
You would be surprised to know that dietary supplements can be manufactured and marketed without notifying the FDA or even receiving their approval. The FDA isn’t authorized to approve that these are safe or effective at doing what they claim. Manufacturers of dietary supplements are only required to meet specific label requirements, submit premarket safety notifications if there are any “new dietary ingredients,” and have to ensure that their products are safe.
The FDA plays a part in inspecting facilities to ensure they comply with specific safety requirements. And if there are ever any public health concerns arising from these dietary supplements, then the FDA can take action against the manufacturers to protect the public. Otherwise, they’re pretty hands-off when it comes to nutritional supplements.
Also known as foie gras in France, the FDA has a big problem with this pate. They intentionally fatten the duck or goose liver or force-feed the animals to become fatter than normal. This has led to a controversial opinion on the treatment of these birds. As a result, several states and countries ban foie gras.
The feeding process involves a funnel and a long tube going down the bird’s throat and pouring food into it. This can add a lot of stress to the bird’s life, with many of them showing signs of fear and damage to their throats. By forcing too much food into the bird, the liver becomes ten times the standard size, restricting blood flow and even making it difficult for the bird to breathe.
Infant Formula Doesn’t Fall Under The Scrutinizing Eye Of The FDA
Did you know that the FDA plays no part in regulating infant formula? Before being marketed, there is no need to seek premarket approval, but the manufacturers are still subject to regulatory oversight. Nutrient requirements and other regulations still have to be adhered to. Manufacturers must also register with the FDA and submit their formula before it can be put on the market.
The FDA also inspects facilities that make infant formula and collects product samples for analysis. If any infant formula has been misbranded or adulterated and presents a risk to human health, the manufacturers are required to conduct a recall to prevent further damage.
Sassafras used to be one of the main ingredients when making root beer, but this is no longer the case. This is because sassafras contains an ingredient called safrole, which is actually carcinogenic. Tests revealed that it contributed to liver cancer in rats when given high doses. This led to the ban on sassafras by the FDA.
Today’s modern root beer no longer uses sassafras, instead relying on other ingredients in order to achieve the same flavor. Some have stated that recent studies have failed to prove that the effect in rats has occurred in humans, making the ban not worth it. Other ingredients like nutmeg also have safrole, and that isn’t banned either. So, is there really the need to ban it outright when safrole is still out there?
Surprisingly, The FDA Does Regulate Tobacco Products
Tobacco products are not food or medications, so they would not fall under the FDA’s spectrum. There’s also no such thing as a safe tobacco product. Thus, the safety and effective standard wouldn’t even apply to them in the first place. The only part the FDA plays when it comes to tobacco products is creating regulations based on the public health standard.
Manufacturers must first receive authorization from the FDA if they want to sell or distribute a new tobacco product. You can do this in one of three ways: substantial equivalence applications, premarket tobacco product applications, or receiving an exemption from considerable equivalence requests. Receiving authorization doesn’t indicate that the tobacco product is safe in any way or approved, only that it has complied with certain requirements.
Suppose you’re not sure what medical food is. In that case, it is a distinctive food product formulated to meet a specific dietary requirement in managing a disease or condition with specific nutritional requirements. This is all based on medical evaluation and specific scientific principles to arrive at the creation of these products.
For example, there is a condition called phenylketonuria, which is a genetic disorder. You need specific medical foods free of phenylalanine, an amino acid normally present in food. Medical foods are not the same as diet shakes or meal replacements; you must consume them under the supervision of a physician. One thing that makes medical foods different from other market products is that they don’t have to have a Nutrition Facts label. Furthermore, some countries approve ingredients and products by the FDA while others keep them banned for several reasons. It’s time to take a look at the other side of the spectrum.
Poultry from the United States is Banned in Many Countries
Millions of pounds of chicken are eaten every year in the United States. But you may not know that other countries bans poultry from the United States. This is because of the presence of arsenic. Arsenic is naturally in the soil and water of farms, which plants absorb. Chickens, pecking at their food on the ground, can pick up this arsenic and it settles into their meat.
Fish, shellfish, dairy products, and cereals prepared with this contaminated water are also at risk of arsenic presence in them. So that’s why the European Union, Japan, and other countries, have banned the import of livestock feed and poultry from North America. On the other hand, the FDA defends the low amounts of arsenic found in these products.
Potassium bromate is an additive that is used in baking, especially in the production of bread. It is one of the cheapest oxidizing agents on the market that helps to improve the quality of bread. However, studies have shown that it is also an additive that can cause cancer in rodents. When given orally to humans, it is damaging to the kidneys, impairing their function significantly.
However, potassium bromate is still in the United States, even though Canada, China, Brazil, the European Union, and several other countries banned it. It’s a wonder why such a dangerous substance would be approved by the FDA. Why? Because it has such harmful effects on a person’s health. But perhaps it’s too late to change anything because of how widespread the process is. Plus, just how much bread is out there on store shelves.
Europe Has Also Banned this Chemical that the FDA Approves
Grain products from the U.S. are no more. Why? Because of the presence of azodicarbonamide or ADA. People also call it the “yoga mat” chemical because you can find them in yoga mats as well as bread. It is a chemical agent that conditions the dough and whitens it. It’s not necessary to make any bread or cereals taste good. However, the FDA still approves it.
Europe banned ADA despite being in almost 500 common grocery stores and restaurant chains. Subway, McDonald’s, and Wendy’s have all removed the product from their ingredients, despite still being FDA-approved. Even the World Health Organization has gotten involved because the chemical is a carcinogen linked to many diseases. Whether general bread and cereal manufacturers will remove it from their products is unknown.
Although milk is not a big export for the United States, it wouldn’t get very far anyway if it was. That’s because a large part of the dairy industry uses rBST or rBGH hormones in their cows, which helps to stimulate milk production. The FDA has stated that there is no difference in the milk produced from cows treated with these hormones, but other countries aren’t going to take a chance. Canada and the EU have both banned milk coming out of the United States.
Research on these hormones as they affect human health is mixed in their results. Some have stated that consumption of milk from hormone-treated cows may lead to higher cancer risk, such as pre-menopausal breast cancer. These studies have called for people to look for dairy products with ingredients from cows with hormones.
Everyone expects Stove Top Stuffing around Thanksgiving time. It’s a great way to spice up a turkey dish with seasoned ingredients that you add to the internal organs to make it taste great. However, this Thanksgiving favorite is missing in several countries because of the use of BHA and BHT. Some preservatives help to keep the ingredients fresh for as long as possible.
However, studies have shown that in high doses, BHA and BHT cause cancer in mice, rats, and hamsters. For this reason, they are completely in order to protect the health of these countries’ citizens. They could likely use other preservatives that aren’t carcinogenic. However, the FDA doesn’t seem interested in making the manufacturers of Stove Top Stuffing change their ingredients or practices.
Did you know that chicken produced in the United States is washed with chlorine? No one is sure who thought that would be a good idea, considering chlorine is a toxic substance. But apparently, it seems to be the only measure to prevent diseases like salmonella from spreading. Seems like something of a good idea, but is this the only practice that can prevent this from happening?
It has been banned in the United Kingdom and the European Union on the basis that washing chicken in chlorine promotes unsanitary farming practices, allowing farmers to keep chickens in whatever conditions they feel like, as long as the poultry gets washed in chlorine at the end. It really makes you question whether we should be eating American chicken too…
If you’ve ever wondered why you won’t find American ice cream products in other countries, that’s because of the presence of carrageenan. Carrageenan is an emulsifier, thickener, or stabilizer that is mostly used in dairy products to keep them stable. Companies use it in ice cream, salad dressings, soy milk, chocolate milk, and some meat products. It is a naturally occurring substance extracted from red seaweed.
The reason that it’s banned is that studies show a link to colon cancer, rheumatoid arthritis, IBD (inflammatory bowel disease), and IBS (irritable bowel syndrome). For this reason, the European Union completely banned this ingredient. They have even banned carrageenan use in baby formulas. However, the World Health Organization has stated that it is safe for carrageenan to be used in infant formulas as long as it is not more than 1000 mg/L.
Ractopamine-Filled Meat Is A Big No-No Anywhere Else
If you’ve never heard of ractopamine before, you’ll never forget the name after this. Ractopamine is a drug used in livestock that increases the growth of lean muscles. Essentially, people use it to produce more meat from each livestock to make more money per head. Forty to sixty percent of the pigs in America contain ractopamine in order to develop bigger pigs.
As many as 160 countries, including Russia, China, and the European Union, have banned the use of ractopamine in their meat production. The FDA has stated that meat from animals that eat ractopamine is entirely safe. How? Because it has been completely metabolized and is no longer present in the meat by the time they harvest the animals. However, the ban is likely to do more with the inhumane treatment of animals. That is, rather than whether the meat is safe for consumption.
The FDA Approves Olestra, But Most Countries Still Ban It
During the 90s, Olestra came to the market as an oil that tastes no different from that used in your favorite snack foods but promised to help you lose weight in the process. People often used it in the “diet” versions of Pringles, Doritos, and Ruffles. However, ingestion of Olestra led to diarrhea, cramping, and loose bowel movements, making it very inconvenient for people to go about their normal daily routine.
And this was after the FDA had approved Olestra. Because of these unfortunate side effects, Canada and the European Union banned this ingredient. Olestra and Olean are still being used to this day in other foods labeled as “diet.” Thus, it would be best to read the ingredient lists and avoid them if you’re not interested in spending your entire day on the toilet.
Everyone’s Favorite Coffee Additive Isn’t In Other Countries
Coffee Mate is most people’s first choice when adding creamer to their coffee. But it is filled with trans fats like cottonseed and partially hydrogenated soybean oils, which doctors link to heart disease. The FDA officially banned them in the United States in 2018, but that hasn’t stopped them from being out in the market. For this reason, Hungary, Austria, Iceland, Switzerland, Norway, and Denmark also banned this coffee product.
Most people would prefer to use actual creamer, but this option isn’t open to those who want creamer but are lactose intolerant. They may want to skip the Coffee Mate until a healthier option is available. Or, you can settle for a variety of lactose-free milk that still protects their health without the horrible side effects of lactose.
You’ve probably seen the bright green drink on several shelves in your grocery store, but you’re never going to find them in Japan and Europe. Not the way the United States makes it, anyway. Both Mountain Dew and Fresca contain an ingredient called BVO or brominated vegetable oil. This comes from a chemical called bromine, which is in brominated flame retardants. When taken into the body, the levels can build up, resulting in memory loss, as well as skin and nerve problems.
The purpose of the brominated vegetable oil is to keep the citrus flavor from separating from the rest of the beverage. Why? So that it can remain homogenous. Still, despite this, it’s not illegal in the United States to be used as an ingredient. However, a petition started by a teenager in Mississippi to drop the component has led PepsiCo to agree to stop putting it in their Gatorade drinks.
You Won’t Find Little Debbie Swiss Rolls In Other Countries
Little Debbie Swiss Rolls contain Yellow 5 and Red 40, both food colorings that can adversely affect children. For this reason, Norway and Austria banned them. Other European Union countries have warnings placed on the box, so parents know the dangers of buying this product. But you don’t find those warnings in America.
Yellow 5 and Red 40 both have FDA approval. However, some studies show that there is an association between these dyes and hyperactivity in children. Yellow 5 links with behavioral changes, such as depression, irritability, difficulty sleeping, and restlessness. Other studies reveal that this isn’t the same reaction in all children. Perhaps genetics also play a part in whether they’re affected or not.