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5 Questions We Have About the New FDA-Approved Weight Loss Pill

5 Questions We Have About the New FDA-Approved Weight Loss Pill


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Achieving a healthy weight is definitely important—but we're not sure if any pill could replace eating healthier.

When it comes to weight loss, it seems like most of us wish there was a magic bullet that could make the whole thing easier. So when it was announced the FDA had approved a new weight loss pill this week, I knew lots of people would be excited. As a registered dietitian, however, I had some questions—and a few concerns.

The new weight-management device is called Plenity, and is made by a biotechnology company in Boston called Gelesis. Now that it's cleared FDA approval, it is expected to launch later this year. You can read more about the device and how it works here, but there are a few key points I want to call out:

  • It’s approved for people with a body mass index (BMI) of 25 or more with no other health conditions.
  • Instead of increasing metabolism or suppressing appetite by altering brain chemistry (the way some weight-loss pills in the past have done), this capsule works by expanding in your stomach to help you feel more full.

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Here are my questions so far:

How will it be prescribed?

Your body mass index, or BMI is calculated via your height and weight (learn more about how BMI is calculated). Because BMI only looks at height and weight it doesn’t necessarily offer a fully accurate picture of health. For instance, It doesn’t account for muscle mass or body fat percentage or weight distribution. It also doesn’t change based on sex, so the number ranges are the same for men and women. In short, It’s not the best measurement for assessing someone’s health.

Technically, a BMI of 25 or greater is considered overweight (30 or greater is considered obese). And Plenity is approved anyone whose BMI is at least 25. This means a woman who is 5’4’’ and weighs just 147 pounds (BMI = 25.2) or a 6' tall man who weighs 185 pounds (BMI = 25.1) would be able to take this device.

What does it do to your gut?

If you watch this video, which explains how Plenity works, you learn that particles made with cellulose from the pill expand in your stomach and small intestine, mixing with food "to increase the volume," and make you feel more full. Eventually they travel down to your large intestines, where they shrink back down.

We’re still learning a lot about gut health, including the importance of eating prebiotics and probiotics. Given how important gut bacteria are, and how much food absorption occurs in the intestines, I'm curious about how Plenity affects the gut microbiota. If it's degrading (or changing) the microbiome, this could be problematic.

Cellulose (what the pill is made of) is a non-digestible plant fiber. According to the press release, “the remaining cellulosic material is expelled in the feces.” That makes sense, as it's what happens with all non-digestible fiber. But it doesn’t tell us how much fiber is actually in the pill or the impact it has on our gut health.

Will it help people eat more healthy food?

Being healthy isn't just a matter of eating less, it's also about eating the right kinds of foods, and getting plenty of natural fiber, healthy fats, and protein. Choosing foods that contain these three nutrients generally help you stay satisfied for longer because they take longer to digest. And foods that contain these nutrients also contain other beneficial compounds. Vegetables and fruits have fiber and also deliver vitamins, minerals and antioxidants.

While PLENITY says it is meant to be used in combination with a healthy diet and exercise, I wonder if it will actually help people change their eating habits, or if it will make change harder, especially since becoming "full" from low-calorie foods can mess with hunger and fullness cues.

Does the research really prove Plenity works?

The FDA approval was largely based off of this weight-loss study, which was sponsored by the manufacturer. The study looked at 324 people over 6 months (112 withdrew from the study for lifestyle or personal reasons). Participants ate a calorie-controlled diet and consumed 300 calories below than their baseline estimated energy needs. They were also advised to get some moderate exercise (for example, a 30-minute walk).

The group taking Plenity lost 6.4 percent of their body weight compared to 4.4 percent for people taking a placebo. There were no significant differences in heart-disease risk factors, such as cholesterol, or insulin resistance. The most common reported side effects were mild and GI-related: “diarrhea, abdominal distension, infrequent bowel movements, flatulence, constipation, nausea, and abdominal pain.”

The weight-loss difference is statistically significant, yes, but it’s not that different (6.4 percent compared to 4.4 percent). What's more, the study doesn’t touch on the types of foods people were instructed to eat or if people taking Plenity ate less food. In real life, outside of a research setting, most people are making their own food choices without nutrition counseling and support that the participants had in this study. It may be harder to make healthy food choices around different foods and portions without that support, even with Plenity.

Do we really need a new weight-loss tool?

And my biggest question of all: do we really need this? The weight-loss industry is a 60 billion dollar force. Quick fixes, restrictive diets and weight-loss pills have never made us healthier. The solution to being healthier is simple, if it's not always easy: Eat more vegetables, don't stress too much, and find ways to move your body (walking, dancing, yoga, running, lifting weights—whatever makes you happy). Those things can all help us actually be healthier, and this pill doesn't seem to address any of them.

The FDA has made mistakes with weight-loss drug approval before (looking at you fen-phen) and there are plenty of unregulated weight-loss supplements and detox teas out there right now that at best give you mild GI symptoms and at worst can lead to serious health risks. Eating disorders are the most deadly mental health disorder. I’m curious to learn more about Plenity. And while it sounds safer than some of the previous weight-loss pills, I still remain skeptical.

...

This story has been updated. The original version incorrectly called Plenity a weight-loss drug. It is actually classified by the FDA as a weight-management device. The participants in the weight-loss study were also not given meals to eat, as the original article stated, but rather counseled on their diets, and given a specific calorie goal.


FTC warns about a potential weight loss pill scam

As more people are settling their fitness goals ahead of the holidays, experts want to warn you about some new potential scams.

We've all seen the lose 30 pounds in 30 days advertisements. Now the Federal Trade Commission has a new warning asking you to be leery of the products you take to lose weight.

The FTC has investigated, sued, and stopped many companies that made false weight-loss claims in their ads. One company was LeanSpa, which used fake websites and false news reports to promote their products.

There are some ways for you to avoid being a victim of these scams.
No product will let you eat all the food you want and still lose weight. Permanent weight loss requires lifestyle changes. So don't trust any product that promises once-and-for-all results.

Even if you see ads for FDA-approved fat-absorption blockers or appetite suppressants, there’s no one-size-fits-all product guaranteed to work for everyone. In recent years, the FDA has discovered hundreds of dietary supplements containing potentially harmful drugs or other chemicals not listed on the product label.


A potential 'game changer' drug for weight loss and obesity was just approved by the FDA

Semaglutide (brand name Wegovy) is a once-a-week injection that will help manage weight in people with overweight or obesity and who have at least one weight-related condition, such as high blood pressure or type 2 diabetes , the FDA said.

"Today's approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program," John Sharretts, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research, said in the statement. "FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight."

Experts have called the drug a "game changer" for people who need help controlling their weight.

Studies on semaglutide have shown it can help patients lose significantly more weight than a placebo when combined with proper diet and exercise. The medication is considered safe, with minor and temporary side effects like nausea or diarrhea in some people.

Novo Nordisk, which makes the drug, said it plans to start selling it in the US later this month. The company didn't disclose the treatment's price in a press release.

Patients who stopped taking the medication in clinical trials regained the weight they lost, suggesting people will need to keep taking the drug to maintain the benefits.

Semaglutide was first approved to treat type 2 diabetes in 2017, so more research is needed on the potential long-term effects of the medication.

A representative from Novo Nordisk told Insider that the drug will be available in pharmacies later this month, and pricing information will be available in the near future.


Thank you!

Pricing information is not yet available. A Gelesis representative tells TIME that the company is “committed to making sure Plenity is affordable for consumers out-of-pocket, even if their insurance does not cover it.” A limited launch of the device is expected during the second half of this year, with widespread availability slated for 2020, Gelesis says.

Gelesis says the device has been shown to help people lose an average of 10% of their body weight in six months. In one Gelesis-sponsored study, which was published in the journal Obesity last fall, researchers including Apovian found that people taking Plenity had twice the odds of losing 5% or 10% of their body weight over six months, compared to people taking a placebo. Plenity seemed to be particularly effective for people with elevated fasting blood glucose levels and prediabetes, according to the study.

The most common side effects reported in the Obesity study were gastrointestinal symptoms. The device should not be used by pregnant women, people who are allergic to the device’s contents, those with esophageal abnormalities or strictures or individuals with complications from previous gastrointestinal tract surgeries. People with active gastrointestinal issues and those taking certain prescription drugs should also use caution, the company says.

Primary care doctors typically recommend that people who want to lose weight start with lifestyle adjustments, such as moving more and eating healthfully, and Apovian calls these the cornerstones of weight management. But given that more than 70% of American adults are overweight or obese, and about half of American adults say they’re trying to shed pounds, regulated weight-loss treatments can provide a valuable second strategy.

The original version of this story misstated the terms of Plenity&rsquos FDA approval. It was cleared as a device for weight management, not a drug for weight loss.


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A New “Game-Changing” Weight Loss Drug Approved by the FDA

This is awesome! The FDA just approved a “new” weight-loss drug Wegovy, touted as a “game-changer” by many media outlets and medical expert sources. With the obesity rate in this country escalating over the last two generations, it is clear we need another weight loss drug. Because weight loss drugs are the answer to the obesity crisis…………said no Metabolism Expert……Ever……… Said no Obesity Medicine physician ever.

There are currently 6 (now 7) FDA approved weight loss drugs: Xenical/Alli (orlistat), Qsymia (phentermine-topiramate), Contrave (naltrexone-bupropion), Saxenda (liraglutide), Belviq (lorcaserin), and phentermine, the most commonly prescribed. Four of these were approved just over the last decade. As I have discussed in past blogs and lectures on metabolism and in past obesity conferences – https://www.a4m.com/weight-symposium-boston-2017.html#schedule -, I predicted that these drugs would do nothing for the obesity rate in this country and cause significant harm. Remember Fen-Phen? Already we are seeing damage these drugs are causing. In fact, Belviq (lorcaserin) is being formally looked at by the FDA to be pulled off the market due to its increased cancer occurrence. I mentioned this risk at a national conference four years ago. These are issues already known before approval. Qsymia will be the following weight loss drug to be “questioned” and pulled from the market.

The issue is everyone is looking for a quick fix. The demand is there. Pharmaceutical companies are primed to make billions (that is, millions with a B). Obesity is the fastest-growing chronic disease process, and along with that comes diabetes, heart disease, and cancers. Of course, people are looking for quick answers, and the FDA is willing to approve quick fixes. Unfortunately, you will not find an obesity fix in a pill.

Now let us talk about this “new, game-changing weight loss drug” Wegovy. Like many of the “new drugs,” it is not new. Wegovy, or the generic semaglutide, is a well-known diabetes medication noted to help people reduce hunger and eat less. Semaglutide was tested in Phase III clinical trials showed a weight loss of approximately 15% over a year and a half with the usual side effects (nausea, cramping, weird bowel movements). This amount of weight loss is more significant than the other FDA-approved medications which average a 5% to 8% weight loss. However, none have shown to sustain the weight loss, and all have statistically and clinically significant side effects. Do you see yourself taking these drugs for life? And then there is the cost: Average $1200 a month without insurance. Even with insurance, with over 70% of our population overweight (yep, that is correct), this cost is not practical nor sustainable. Even if insurance covers it, what do you think will happen to health insurance rates? The European Medicines Evaluation Agency (EMEA), Europe’s FDA equivalent, has not approved the drug…..yet.

So, we now have another FDA-approved weight-loss drug, expensive and unproven for sustained weight loss……….a drug with questionable long-term safety issues that makes you eat less, allowing your body to become more efficient in storing calories. Our society values big servings, profit, and quick fixes. We are overexposed to fast-food marketing. Our brains are wired physiologically to take in high-calorie foods. We crave salt, fat, and sugar, and it is available to be dropped off at our doorstep with a click of an app. No exercise is required. All of this is a setup for failure.

A sad issue is that there are hundreds if not thousands of studies on weight loss but minimal discussion on sustaining weight loss and even less on addressing metabolic repair as the primary approach for metabolism management. Metabolism management should be the primary goal of all obesity studies. Metabolism repair should be the focus of physicians.

I KNOW you are frustrated. There is a balance between personal responsibility and physician intervention. The longer someone is in an overweight or obese state, the harder it is to get out of it. There is a role for anorectics/appetite suppressants/”weight loss” drugs. I prescribe them. But that role is NOT to lose weight. The brain needs to be rewired from the desire for calorie-dense foods to high-nutrient foods. The focus needs to be on metabolism and metabolic repair. That should be the goal of ANY weight loss approach. In a 15-minute appointment, your doctor cannot provide sound advice for proper metabolic repair. This is another reason for the appeal for these FDA-approved weight-loss drugs: Just write the prescription and tell you “This will help you lose weight” and kick you out the door…..”Next!” If you are only being told to “exercise more and eat less” – https://atlantismedcenter.com/blog/bad-advice-from-your-doctor/ -, then you are being ignored.

Soon you will see more articles and pharmaceutical ads on TV for the “game-changing” weight loss drug………And now you know.


Announcer: Covering all aspects of women's health, this is "The Seven Domains of Women's Health" with Dr. Kirtly Jones on The Scope.

Dr. Jones: Four in 10 women are obese, and over 2 in 10 are overweight. That adds up to 6 in 10 women who are overweight or obese. And many of these women would like to lose some weight. And many of those women have medical problems, such as diabetes, or pre-diabetes, or high blood pressure that would be improved or resolved with weight loss.

Okay, diet and exercise can help with weight loss, and exercise alone doesn't really lead to much weight loss. So the focus of interventions for weight loss is diet. There've been medications approved to decrease appetite. These medications change brain chemistry to decrease interest in eating, but these medications have side effects and some of them are very significant, and the FDA has been very careful about approving new weight loss medications.

Many women who take these medications gain their weight back when they stop them. The alternative is weight loss surgeries that decrease the room in your stomach or decrease the absorption of food in your intestines. This approach has been the most successful for sustained weight loss, but it's expensive and with all surgeries it can be risky.

So what if you feel full before you ate, sort of like weight loss surgery without the surgery? The FDA just unanimously approved a new device for weight loss. The device is a pill with a special compound called Gelesis 100 that absorbs water. If you take these pills 20 to 30 minutes before you eat and drink half a liter of water, which is about two eight-ounce glasses, the compound, which is cellulose, swells up and fills up your stomach so that you aren't too hungry and you can't eat so much. The compound is like those over-the-counter bulk laxatives, a cellulose compound.

Now how well did it work? The GLOW study, that's the name of the study with Gelesis as the G, published in the "Journal of Obesity," was conducted in the U.S. and was sponsored by the manufacturer. About 400 men and women took the active pills or placebo with two eight-ounce glasses of water 20 to 30 minutes before lunch or dinner for six months. The average weight loss for those who took the active pills was about 6% of their body weight, and those who took the placebo pills was the average about 4% of their body weight.

So in a 200 pound person . . . Now of this is for people who are math averse, so I'm doing the numbers for you. The average weight loss was 12 pounds over 6 months in the active group and 8 pounds in the placebo. Now looking more carefully at these results, it appears early on that you could predict who is going to lose weight with the pills and who wasn't. Of course, eating patterns are different person to person. If you get lots of your calories in snacking between meals, and that's such an American thing, taking these pills before meals won't make a difference, because you will have already snacked up your calories in there too late. If you're someone who doesn't really pay attention to how full you are before you eat that second serving of pizza or that dessert, that won't make a difference.

But for those who were losing weight on the active pills in the first several weeks, they were very likely to lose over 10% of their body weight in 6 months, about 20 pounds for a 200 pound person, and that's significant.

And among the participants with pre-diabetes or lifestyle treated type two diabetes, people taking the active pills were 6 times more likely to lose 10% of their baseline weight by the end of the study. And people who are pre-diabetic, or had diabetes that was treated with diet, were more likely to have a significant drop in their fasting glucose and insulin. So these pills helped people with diabetes or pre-diabetes get better control over their sugars.

Now unfortunately, the study didn't differentiate between men and women, and that's outrageous. There's the . . . I got the numbers. They should have done that. Women probably eat differently than men, have different eating and fullness cues, and we're going to need to find out more about that.

Now, one quarter of the participants dropped out in both the active pill group and the placebo group. Now that may be related to how hard it is to eat moderately, one, on a schedule, two, exercise 30 minutes a day, and three, drink water and take pills. All were required of the study, and, of course, there were side effects that were bloating, that only women use and I've never heard a man use, was more common in the active pill than in the placebo. Of course, they didn't call it bloating. They called it fullness or distension. It was noted 11% of the time in active pills and 6% in the placebo group. There you go, take nothing and you get bloated. I don't figure that one out.

Now, tummy side effects were common, 43% in the active pill group and 34% in the placebo, but that's how the pills work. The cellulose, which expands to fill up the stomach breaks down as it passes through the intestines and the large bowel, and it's excreted with bowel movements and so you have more bowel movements.

The product which will be called Plentity, that's kind of a cool name, is termed a device because cellulose is a commonly available chemical in food and in laxatives, but the way it's delivered in these pills makes it unique. It will be marketed in the fall of 2019 and available probably in early 2020.

So how does this help the overweight or obese woman who wants to lose weight? Well, firstly, you have to know your pattern of eating and whether you can change it to eating most of your foods at lunch and dinner and not snacking or drinking those mocha frappuccinos. Keep a log of what you eat and when you eat it so you can figure this out. If you don't want to wait until this new weight loss device is available, you can drink two large glasses of water before lunch or dinner.

In the GLOW study, those drinking water and the placebo also lost weight and water's free. Or you can do what some dietitians have suggested, and that is to eat a large bowl of low-calorie vegetable soup before your regular lunch or dinner. This soup thing is common all over the world and particularly in Asian cultures. This has also been shown to facilitate weight loss in American women.

Or you can buy a bulk laxative like psyllium. Take two doses with two large glasses of water before lunch and dinner. This is much like the strategy of this new weight loss device. It's also been shown to facilitate weight loss. Taking this much new soluble fiber in your diet all at once may have the same side effects as this new device, fullness, and that's the goal, nausea, bloating, more frequent bowel movements, that's also the goal of bulk laxatives, and possibly diarrhea.


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One Shot Keto Reviews – Alarming Weight Loss Truth Revealed!

April 10, 2021 06:00 ET | Source: Marketing By Kevin Marketing By Kevin

Homewood, Illinois, UNITED STATES

Denver, CO, April 10, 2021 (GLOBE NEWSWIRE) --

Weight loss has always been a hot topic among people, and it comes as no surprise that almost everyone has the advice to give in regards to weight loss. Most of these self-proclaimed experts reside on the internet, advising people on their channels or blogs.

The most popular weight-loss method is dieting, and the most popular diet of all is the keto diet. The reason for the popularity of keto diets is that it helps you lose weight quite fast. But sometimes, just going on a keto diet may not help. And for your body to reach a state of ketosis all by itself is almost an impossible task and can take up to two weeks to achieve.

Ketosis is the process where the body burns stored fats instead of carbs (carbohydrates). Getting your body to achieve this state is quite difficult because you need to have ketone bodies in your blood. And this is the main reason people go on keto diets, where they restrict themselves from eating a huge amount of carbs. But even with a keto diet in the picture, it is hard for individuals to achieve and maintain the state of ketosis.

And that is exactly why various kinds of dietary supplements will help you achieve the state of ketosis. But you have to be careful when you are selecting and purchasing a supplement. Quite a lot of supplements contain harmful elements like chemicals and toxins, which can negatively affect your health, which is why you should make sure you are aware of the contents of the supplements.

But you can push that worry aside, and we are here to tell you about a dietary supplement that is so good that it is growing in popularity like never before. This supplement is called One Shot Keto.

One Shot Keto is a popular weight loss supplement that uses only naturally occurring ingredients and does not contain synthetic ingredients or chemical elements.

But is this supplement worth the hype? And more importantly, does it work?

To answer these questions, we will take a closer look at the ingredients and the benefits they have to provide. One Shot Keto: A Small Overview

One Shot Keto was brought into the market as one of the most powerful keto weight loss supplements with a formula that uses exogenous ketones to produce nutritional ketosis in the body. According to their website, One Shot Keto contains enough ketones to help you follow your keto diet regime more efficiently.

The trend of keto diets has created quite a stir amongst those seeking to use a natural supplement to lose weight. As mentioned earlier, going on a keto diet means that you have to limit your intake of carbs to help the body transition into burning fats instead of carbs. Even though it sounds quite simple, the process is not. It takes a lot of time for an individual to achieve the state of ketosis, mainly because following a low-carb diet for an extended period of time can be difficult, and even one cheat meal can throw all of your progress off.

Moreover, when people go on keto diets without consulting a nutritionist, they always feel low on energy and feel extremely weak. This is where One Shot Keto can help you. It can help your body achieve the state of ketosis without you having to go through all this.

One Shot Keto pills are designed to help you get the optimal number of ketone bodies in your blood. This way, your body achieves the state of ketosis at a much faster rate, and as a result of that, you will able to get rid of the excess fat quickly, and you will also feel more energetic than before.

But it would help if you kept in mind that results may vary from person to person, which means that the time taken for One Shot Keto to induce its effects may vary from individual to individual.

One Shot Keto: How Does It Work?

As per the official website, One Shot Keto basically provides the body with essential nutrients that will help the body enter the state of ketosis. During the state of ketosis, your body is filled with ketones, and ketones are nothing but tiny chemical bodies produced in the liver when stored fats are broken down.

As you know, when your body enters the state of ketosis, it gains its energy from stored fats and not from carbs as it usually does. But here is how this happens, when you stop giving your body carbs or glucose, it starts looking for an alternative energy source, and that is your stored fat.

And when the body starts burning fat for energy, ketones are released as a byproduct of that, and when the ketones reach a particular stage, your body is then in a state of ketosis.

Here is how One Shot Keto helps this process. These capsules contain a solution filled with electrolytes that mimic the effect of stored fat inside your body. When the capsule reaches your gut, it is broken down and releases pre-made ketones to assist the body in entering the state of ketosis.

One Shot Keto: What Are The Ingredients Used?

As mentioned earlier, the ingredients used in making this supplement are all naturally occurring, and they do not pose any threat to your health.

One Shot Keto contains two main blends, namely a BHB Ketone blend and a Detox blend. Both of these blends contain various other naturally occurring ingredients.

Listed below are the ingredients used in the making of One Shot Keto

BHB Proprietary Blend (800mg Per Serving)

This particular proprietary blend contains a good amount of nutrients (potassium, calcium, magnesium, and sodium) combined with a Beta-Hydroxybutyrate (BHB) blend. The above-mentioned nutrients are also referred to as ketone mineral salts. Apart from helping the body enter the state of ketosis, it also improves your body’s overall health.

Detox Proprietary Blend (300mg Per Serving)

As mentioned above, the detox proprietary blend consists of several naturally occurring ingredients listed below are the natural ingredients used to make the Detox proprietary blend:

Green Tea Leaf 4:1 Extract

Camellia sinensis is a plant that contains this ingredient in the One Shot Keto nutritional supplement. It was first found in China. After that, it spread worldwide due to its delectable flavor and a long list of nutritional benefits, the majority of which are due to the increased amounts of powerful antioxidants.

Green tea is especially high in epigallocatechin, a compound that promotes fat oxidation in the body. It may also improve hydration, aid loss of weight, and safeguard you against a spectrum of ailments.

Niacin is a B3 vitamin that has several nutritional advantages. It's been used for a variety of ailments, including hyperlipidemia and any potential vitamin B deficiency. In fact, this vitamin plays an essential role in the detoxification process within the body. The body is in a healthier state to induce fat loss when it becomes detoxified.

Green Coffee Bean 2:1 Extract

Green coffee bean extract is made from unprocessed coffee beans and therefore has an abundance of antioxidants. Chlorogenic acid, an element of green coffee bean extract, has been proven to have weight loss properties, which is especially useful.

Medium-Chain Triglycerides Powder (MCTs)

MCTs (medium-chain triglycerides) are fatty acid chains with six to twelve carbon atoms. These MCTs are keto-friendly, which means they'll help you avoid the unpleasant side effects and health problems this diet is known for. MCTs have also been shown to accelerate the mechanism of dietary ketosis, according to research.

Garcinia Cambogia Extract

Garcinia Cambogia is a tiny fruit that looks like a pumpkin. Due to the extreme presence of hydroxycitric acid, it has now become extremely well known among fitness enthusiasts. This ingredient has undergone rigorous research and is beneficial in the treatment of obesity.

Garcinia extract used in this supplement will aid in the removal of visceral fat and overall fat content in the body, assisting consumers with powerful nutritional benefits while assisting with weight loss.

Raspberry Ketone

Raspberry ketone is a compound found naturally in raspberries. This substance is responsible for the brilliant red color of these berries and their distinct fragrance. The majority of products on the market today that claim to have raspberry ketones in their formulas is typically made synthetically. One Shot Keto pills, on the other hand, produce only naturally occurring raspberry ketones, according to the makers. Raspberry ketones are one of the main fat-burning ingredients in this dietary supplement. Furthermore, they promote the development of adiponectin, a hormone that aids in fat-burning control.

Black Pepper Extract

Black pepper is a naturally occurring spice widely used in several keto supplements to help with digestion and detoxification. This component will increase the flow of sweat and urine, allowing you to expel all of the harmful substances accumulated in your system and detoxify them from the inside out. As a result, digestive pathways will be strengthened, and the body will shed weight more effectively.

These are some of the main ingredients used in the making of One Shot Keto the rest of the ingredients are

  • L-Tyrosine
  • Dandelion
  • Gelatin
  • Rice Flour
  • Silicon Dioxide
  • Magnesium Stearate

All the ingredients are procured from the most reliable sources, and they are tested to make sure you get the best product. Furthermore, the manufacturers also mention that they follow GMP (Good Manufacturing Practices), the highest standard for testing and manufacturing in the supplement sector.

Benefits Of One Shot Keto

In brief, here are some of the benefits of using One Shot Keto

  • This supplement will aid you with weight loss
  • It is a risk-free investment
  • You do not have to wait for a long period of time, and you can see the results as soon as you start consuming this supplement.
  • This product boasts high-quality ingredients. .
  • It is one hundred percent natural.
  • This supplement also helps in boosting your energy levels
  • It helps in maintaining overall health as well

These are some of the many benefits that One Shot Keto has to provide.

One Shot Keto: Dosage

The recommended dosage is two capsules every day with a glass of water. Ideally, it should be taken alongside a meal or as suggested by a medical professional.

Making sure you take this supplement regularly is important. It would be best if you consumed this supplement for at least a time period of 3 to 5 months, which will help your body adapt to the changes it is going through.

Where To Purchase One Shot Keto?

You can purchase One Shot Keto on their official website only and nowhere else. Not making this supplement anywhere else is a smart move by the manufacturers, as it prevents customers from falling prey to fake manufacturers with fake products.

Here are the pricing options available:

  • One Bottle - $69.99 (includes free shipping)
  • Two Bottles - $49.97 per bottle + get one bottle free (includes free shipping)
  • Three Bottles - $39.74 per bottle + get two bottles free (includes free shipping)

Are One Shot Keto Scam Complaints Real?

Depending on where you go to shop or seek real One Shot Keto customer reviews, there are a few glaring issues that pop up and must be addressed properly in order to get the most bang for your buck as well as reassured consumer protection regarding the fake OneShot Keto pills. There are two very important caveats to know right away, and that is 1) ALL the One Shot Keto scam complaints about negative side effects and harsh adverse reactions found online are from non legitimate vendors and marketplaces who are selling inferior ripoff weight loss diet supplements under the same brand name and 2) One Shot Keto Shark Tank advertisements are 100% fraudulent and should not be believed in at all.

Of course these both have nothing to do with the actual ketosis boosting fat burner, but there are very serious risks involved with buying fake Limitless One Shot Keto diet pills from unauthorized third party retail platforms. Between the One Shot Keto side effects coming from negative reviews of those who bought off of Amazon or Ebay or Walmart, to the same brand different product listings that do not offer any sort of money back guarantee or company transparency, thankfully it is very easy to avoid all these negative One Shot Keto customer complaints by ordering directly from the official website only. Then, as touched on, it is wise to not believe or be lead to think that Shark Tank endorsed One Shot Keto pills like some falsified promotions found online are trying to suggest. To date, no ketone weight loss supplement has ever been featured on Shark Tank TV show, especially not the One Shot Keto variety. That doesn't imply that One Shot Keto is an outright scam, it only reveals that there are shady actors who promote the product in a fake way that is meant to lure unsuspecting consumers into the buying process thinking it is a highly touted formula for burning fat for energy via BHB ketones. But the irony is, One Shot Keto ingredients are some of the most diverse and robust formula on the market for a ketosis boosting supplement, so it does not need to have fake advertorials to showcase its high profile extracts and ketogenic diet-friendly benefits.

It comes as no surprise that this supplement can truly work wonders. And yes, One Shot Keto is one hundred percent worth the investment. With a supplement like this to help you with weight loss, you can be sure to achieve your fitness goals in no time.

Contact Details: OneShot Keto

Email: [email protected]

Phone: TOLL FREE (844) 423-5386 (KETO)

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This product review is published by Marketing By Kevin. Marketing By Kevin reviews are researched and formulated by a group of experienced natural health advocates with years of dedication and determination to finding the highest quality health products and wellness programs available. It should be noted that any purchase derived from this resource is done at your own peril. It is recommended to consult with a qualified professional healthcare practitioner before making an order today if there are any additional questions or concerns. Any order finalized from this release’s links are subject to the entire terms and conditions of the official website’s offer. The researched information above does not take any direct or indirect responsibility for its accuracy.

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Questions and Answers on HCG Products for Weight Loss

FDA and FTC are issuing seven joint warning letters to firms marketing over-the-counter (OTC) HCG drug products that are labeled as homeopathic for weight loss. The firms are receiving these letters because they are violating the Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission Act by selling unapproved new drugs and misbranded drugs that make unsubstantiated claims about weight loss.

These unapproved “homeopathic” HCG drug products are marketed OTC on websites and in retail stores, and can be in the form of oral drops, pellets, and sprays. FDA has not evaluated these products for safety or effectiveness.

FDA and FTC will monitor the firms’ responses to the warning letters and take further action as needed. Firms that do not correct the violations may face enforcement action, possible legal penalties, or criminal prosecution.

2. What is HCG?

Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved for the treatment of select cases of female infertility and hormone treatment in men. FDA-approved HCG products are only available in injection-form and require a prescription from a licensed medical professional.

There are no FDA-approved HCG products for weight loss.

3. Why is FDA concerned about the use of homeopathic HCG drug products marketed for weight loss?

Currently, there are no FDA-approved HCG drug products for weight loss. HCG has not been demonstrated to be effective therapy in the treatment of obesity. There is no substantial evidence that HCG increases weight loss.

Additionally, the labeling for the “homeopathic” HCG products states that each product should be taken in conjunction with a very low calorie diet (VLCD). Consumers on a VLCD are at increased risk for side effects including gallstone formation, electrolyte imbalance, and heart arrhythmias. A VLCD should only be used under proper medical supervision.

4. Which homeopathic HCG products and manufacturers/distributors are affected?

The following table provides the products and manufacturers/distributors that are the subjects of this action. This is not an all inclusive list of illegal “homeopathic” HCG products currently on the market. At this time, all drug products claiming to include “homeopathic” HCG are illegally marketed.

Manufacturer/Distributor Name

Product Name

HCG Diet Homeopathic Drops

HCG 1234 LLC (The hCG Drops LLC)

HCG Platinum LLC RightWay Nutrition

HCG Platinum
HCG Platinum X-30
HCG Platinum X-14

HCG Fusion 30
HCG Fusion 43

Homeopathic Original HCG
Homeoapthic HCG

HCG Extra Weight Loss Homeoapthic Drops

Alcohol Free hCG Weight Loss Formula

5. Are prescription HCG products safe and effective for weight loss?

No. FDA-approved uses for prescription HCG products include female fertility and select hormonal treatment in males, and FDA has not approved prescription HCG for any other uses, including weight loss. Current scientific evidence does not support the claim that HCG is safe and effective for weight loss or for the treatment of obesity.

FDA understands that sometimes approved products are used to treat conditions that the products were not approved for (i.e., “off-label” uses). The “off-label” use of products usually presents greater uncertainty about both the risks and benefits because less information is available on safety and effectiveness. Unexpected adverse events may occur in this context. FDA has received reports of serious adverse events associated with the use of HCG injections for weight loss including cases of pulmonary embolism, depression, cerebrovascular issues, cardiac arrest, and death.

6. What should consumers do?

FDA advises consumers who are using “homeopathic” HCG for weight loss to stop using the product, to stop following any labeled dieting instructions, and to discard the product. Consumers who suspect they have experienced adverse effects as a result of the use of HCG drug products for weight loss should contact a licensed health care professional immediately.

FDA urges both health care professionals and consumers to report harmful effects experienced from using HCG for weight loss to the FDA’s MedWatch Adverse Event Reporting program by doing one of the following:



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