Daily Archives: October 24, 2019

For Immediate Release: October 22, 2019

Today, the U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinsons and Alzheimers disease, among other conditions or diseases.

Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance. We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children, said Acting FDA Commissioner Ned Sharpless, M.D. Weve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements. As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority. We appreciate the FTC joining us on these and other actions to protect consumers from fraudulent CBD products.

As described in the warning letter issued to Rooted Apothecary, the company used product webpages, through its online store and social media websites, to make unfounded claims about its CBD products, and some of the products were also unlawfully marketed as dietary supplements. The agency has determined that CBD products cannot be marketed as dietary supplements.

Examples of the unsupported claims made by the company include:

Additionally, under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. The FTC is concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. These products are also misbranded under the Federal Food, Drug, and Cosmetic (FD&C) Act, because the products labels and product information fail to include adequate directions for use. Drugs in the United States must contain directions explaining how a consumer can use a drug safely for its intended purpose. Under the law, there is an exemption for this labeling requirement for prescription drugs that have FDA-approved applications in effect. However, none of Rooted Apothecarys products are FDA-approved.

The FDA and FTC have requested responses from Rooted Apothecary within 15 working days stating how the company will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or administrative cease and desist order, and an order also may require that a company pay back money to consumers.

The FDA continues to be concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the agency. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.

The FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products while maintaining the FDAs rigorous public health standards.

The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies, said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products. We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.

Unlike drugs approved by the FDA, the manufacturing process of unapproved CBD products has not been subject to FDA review as part of the drug approval process. Further, there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. Consumers may put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, its important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.

The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agencys MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD,...

CreditAriel Davis

Our bodies house an extraordinarily vast collection of bacteria and other microorganisms so many, in fact, that scientists now estimate there may be just as many bacteria in our bodies as human cells.

They thrive on the skin, where they might help protect it from infection, and in areas like the intestinal tract, where they help break down food and absorb nutrients. Given the sheer volume, its no wonder scientists are discovering that these microbes play an important role in health and disease.

Research on the microbiome, that collection of microorganisms, is still in early stages, but it has become increasingly common to hear references to the microbiome in the news and advertising. Last week, Bill Gates wrote an essay for The Telegraph suggesting that correcting an out of whack microbiome by taking next-generation probiotic supplements, for example, or eating certain gut-healthy foods could eventually help prevent some of the worlds most common ills, such as malnutrition, obesity and perhaps even inflammatory conditions including asthma, allergies and some autoimmune disorders.

And Dove has been advertising an infant soap with prebiotic moisture, as well as a lotion claiming that it nourishes babys delicate microbiome. Mother Dirt, a skin-care company, also has said that its biome-friendly cleansers, shampoos, moisturizers and more help restore harmony in your skins microbiome.

If youre still a bit confused about what all of this means and who isnt? heres a short introduction to a complicated subject: the role of the microbiome.

The microbiome is a community of bacteria, fungi, viruses and other microbes that live inside your body and on its surface. Just as in a community of people, youll find both good and bad actors: Some of the microbes, like the gut bacteria that help you digest food, are beneficial, while others, like certain viruses, can be dangerous.

Everyones microbiome differs, depending on your age, gender, diet and immune system. And the types of microbes on one part of the body may be different from those on another.

Imagine the microbiome as basically like a rainforest, said Jonathan A. Eisen, Ph.D., an evolutionary biologist who directs the Microbiome Special Research Program at the University of California, Davis. On any given spot on the skin, he said, there might be hundreds to thousands of different species of microbes, which can come in hundreds of different strains. With E. coli, you cant just say you have E. coli on your skin, because some E. coli make vitamins and others kill you, said Dr. Eisen. So this is incredibly complicated.

Even something as simple as showering can affect the composition of your skins microbiome, he said, depending on the temperature of the water, the products you used and the length of time you spent in the water.

Scientists know that babies receive helpful microbes from their mothers, who pass them on to their children through the birth canal and breast milk, but the specific benefits derived from those microbes are not fully understood.

While theres still a lot that we dont know about the microbiome, scientists say its clear that it plays an important role in health and disease.

It prevents overgrowth by harmful microbes, thats one important function, said Dr. Gregory A. Storch, M.D., a professor of pediatrics at Washington University in St. Louis. Another is that its important in digestion and breaking down food.

The microbiome has also been shown to help the immune system learn the difference between good and bad bacteria, he added.

The gut microbiome plays a role in several gastrointestinal diseases, according to the American Microbiome Institute, and may even influence behavior. Accumulating evidence also suggests that the microbiome could influence asthma, obesity, heart disease, cancer therapies and even autism, but the research is far from conclusive.

In short, yes. The microbiome has become a buzzword that vaguely signifies good bacteria, so some advertisers have promoted their products as being gentle on the bodys microbes. But without studies showing that these products are truly beneficial to the helpful microbes, experts have said that consumers should be wary.

Its become incredibly hot as a scientific area, but also the realm of snake oil, Dr. Eisen said.

With that in mind, Dr. Eisen created an Overselling the Microbiome Award on his blog, which exposes questionable research as well as companies that are touting unproven claims about the microbiome to sell products. I could probably give out one of them a day if I had time, Dr. Eisen said.

When Dove started running ads for microbiome-friendly lotion and bath soap, for instance, Dr. Eisen began dissecting the claims on his blog, one by one, including the idea that Dove was nurturing the microbiome.

Anindya Dasgupta, Ph.D., a scientist at Unilever R&D, which developed a microbiome-friendly line of Baby Dove products, said its infant cleansers and lotions contained nutrients that were identical to those found naturally in skin and help to replenish skin-natural nutrients as well as a prebiotic moisturizer, which serves as an excellent nutrient source for good bacteria, helping to keep the microbiome nourished.

Unilever did not immediately respond to questions about whether the company had conducted studies that supported its claims, nor did the company explain which prebiotics or nutrients were included in its products.

The challenge in this is that some of the bacteria on our skin can be good and some can be bad, and just nourishing bacteria generally does not guarantee that you are nourishing the right ones, Dr. Eisen said.

When it comes to dietary supplements that say they support the microbiome, such as probiotics, its unclear just how helpful they are, said Dr. Martin J. Blaser, M.D., the director of the Center for Advanced Biotechnology and Medicine at Rutgers University and author of the book Missing Microbes.

Theyre almost completely untested for the kinds of things that people are taking them for, Dr. Blaser said.

Recent studies, for example, have found that the probiotic Lactobacillus offered no benefit when treating stomach virus in children.

Even though we know that the microbiome is very important in human health, we cant assume that probiotics and other treatments that try to manipulate or even protect the microbiome will be effective, Dr. Storch said.

In addition, the Food and Drug Administration does not review, approve or strictly regulate dietary supplements or personal care products such as lotions and soaps. And it doesnt approve claims that appear on product labels.

Avoiding the overuse of antibiotics and antimicrobials is one of the best ways to help preserve the microbiome, Dr. Blaser said.

When people are exposed to antibiotics, it disturbs the beneficial microbes, which can lead to antibiotic resistance and create new illnesses.

One of the most clear examples is when antibiotics allow the bacteria Clostridium difficile to proliferate in the gut, which can damage intestinal cells and lead to inflammation in the colon.

Number one: Minimize the damage, Dr. Blaser said. We have to move from a philosophy of, This might not help you but it wont hurt, to, Is this antibiotic necessary?

Given the wide variations in how pediatricians prescribe antibiotics, Dr. Blaser advised parents to have a conversation with their childs doctor about whether antibiotics are truly necessary for certain conditions. Some ear infections and colds, for example, are caused by viruses and will resolve on their own.

Its the germaphobia that encourages killing all types of bacteria that can do more harm than good.

People shouldnt have a fetish about trying to maintain a sterile environment, Dr. Storch said. In some cases I think people are treating their own anxiety rather than any real disease threat.

While Dr. Eisen also recommended avoiding medically unnecessary antibiotics, he warned against going too far in the other direction by, say, encouraging your child to lick the subway poles to strengthen their immune system, something he refers to as microbiomania. Pathogens are real, he added, and they are transmitted by contact between people or between people and surfaces, so youre not going to protect yourself by licking everything.

Wash your hands often, dont touch things that many other people have touched, he advised. And that alone, just that, will help prevent the spread of infectious disease beyond any antimicrobial that they put in toothpaste or clothing or wherever.

Christina Caron is a parenting reporter at The New York Times.

Originally posted here:

Why Do Parents Keep Hearing About the Microbiome? - NYT Parenting

Venus Williams does not play games when it comes to her health. The tennis great revealed her secrets to staying fit despite an admitted love for junk food in an exclusive interview with Us Weekly.

Olympic Athletes: Where Are They Now?

I love junk food, but I just got off tour and I started eating junk food. Honestly, I started feeling so bad I had to stop, the 39-year-old star explained to Us. [I had] donuts. It was bad. I had pancakes. I ordered pancakes at 5 in the morning with jet lag. Its so bad. I was like, No, I cant live like this. I was literally like, How do I get a salad? Im so desperate for a salad.

The four-time Olympic gold medalist, who said she feels her strongest when shes eating a balanced diet, went on to detail some of her tips for keeping her mind and body working at its highest potential. I [eat] lots of greens, lots of fiber. That kind of covers it, so your bodys well nourished,she said.[I get] lots of sleep, very important. Very important for me especially since I train. My body just requires so much sleep because of that.

Celebrities Dating Athletes

She continued: I also travel with a lot of supplements, and I have a specific kit just for anti-virals. I have olive leaf extract, oregano oil. I have garlic, I have lysine and vitamin C. Everyones like, Venus, can I get them? Everyone comes to me for [my supplements] because I literally cannot get sick. I buy supplements and I have a special [kit] I put them in, its always there. Because then youre like, Oh sht, I wish I had that stuffand youre in Timbuktu.

Besides needing to staying healthy for work, the Florida native admits her sister Serena Williams daughter, Alexis, is also a motivating factor. The hard part though is if you do get sick and youre like, Oh man, I cant go see the baby, and you put yourself in quarantine. But youre just like, FaceTime me please.

Stars Theyre Just Like Us!

Venus, who is partnering with Clorox Disinfecting Wipes in an effort to keep the public safe from germs, pointed out that germs which can cause the common cold tend to lurk in some unexpected places. Obviously, its very important for me to stay healthy because my job requires that you are healthy. I just keep wipes everywhere, she continued.In [my] carry on, in my dog bag and my racket bag, and that covers all the bases. I [wipe down] things you dont think of, like when youre in your hotel room. Nobody really uses the [hotel room] phone, but every now and then you have to [make a] call. So, I always have my wipes.

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Venus Williams Reveals Health Tips, Supplements - Us Weekly

And so what can I do I do feel like I was there and helped create a bit of this beast to really stay true to the mission and to spread that to my team?

Talking about it in earnest is one way to address the problem. Chantal Bacon also seeks to live out her values with Moon Juice, which opened its first shop in Venice, California, in 2011 and carries products that offer more than what youll find in just about any grocery store or gas station these days.

What would be the difference between a Moon Juice with some type of pasteurization on it in a cute juice shop and a juice for maybe $2.99 in a grocery store thats the same blend and organic? she asked. It would really be the difference of a label. So that didnt feel worthwhile. Herbs, though, that was something that when you scale it, it makes sense. Your costs go down. Youre able to reach more people. Supplements are actually something that you need scale for safety reasons alone.

In the latest Glossy Beauty podcast, Chantal Bacon discussed Moon Juices focus on research over marketing (people are always surprised to find out that we really dont spend any money on marketing), the companys use of Instagram and its move into beauty and skin-care products.

Here are a few highlights from the conversation, lightly edited for clarity.

Leveling up from the localhealthfood storeGoing anywhere where wellness was a term was a pretty janky health food store with bad lighting and loud sounds and strange smells. So that was really one of the intentions with Moon Juice, was to bring this next level of health, which I wasnt finding in the Vitamin Barns, with the bulk bins of the world.It was to bring some of that fine dining accuracy that Id come to know and trust and employ every day in my own kitchens and where I was working, and really missing that in the health world. Every time you got a juice it was completely different. Sometimes there were bugs in the bulk bin. It was just that angle of aesthetic and precision that was missing.

Herbs and supplements set the product apartThere are great juice companies out there that sell to Whole Foods and any grocery store, [and] any airport around the country, and theyve got organic green juice blends. So truly, what would be the difference between a Moon Juice with some type of pasteurization in it in a cute juice shop, and a juice for maybe $2.99 in a grocery store thats the same blend and organic? It would really be the difference of a label. So that didnt feel worthwhile. Herbs, though, that was something that when you scale it, it makes sense. Your costs go down. Youre able to reach more people. Supplements are actually something that you need scale for safety reasons alone. The amount of energy that we put into sourcing and testing, I couldnt do as a small company. And I knew we needed that to truly come out with the products that I wanted.

All is not well with wellnessI think that is my criticism of the wellness world, if there was one. I think theres so many wonderful things about wellness spreading, but the underbelly of it is this notion of it is for the 1% to live forever by themselves in their castles, looking young. And so what can I do I do feel like I was there and helped create a bit of this beast to really stay true to the mission and to spread that to my team? And to dig deeper into myself and look at how we can swing this thing the other way? And why do we want to be well? What is the point of living longer and feeling better and being stronger?

Research over marketingPeople are always surprised to find out that we really dont spend any money on marketing. Weve got a creative little bubble that is very lean, that goes onInstagram, which is our main marketing channel. I look at every post, Im tweaking every post. It was not so long that I was actually writing and posting each post. And we really do spend our energy and our time and our money on sourcing and testing for potency and safety. And I hope that never changes.

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Moon Juice founder Amanda Chantal Bacon on bringing research to the wellness industry - Glossy

Type 2 diabetes is a condition in which the body cant control the amount of glucose (sugar) in the blood, causing levels to become too high, and left untreated, serious complications such as kidney failure, nerve damage, heart disease and stroke can occur. High blood sugar levels can be prevented or managed with lifestyle changes such as regular exercise, but while the NHS recommends 30 minutes of moderate aerobic exercise five days a week, a recent report by the World Health organisation estimates a third of UK adults arent active enough. Now, new research by experts in New Zealand says consuming a specific type of blackcurrant could help sedentary adults walk for longer without getting tired. The effects took hold just an hour after taking the blackcurrant supplement.

Meanwhile the superfood also resulted in a dramatic 90 percent reduction in the build of enzymes linked to the onset of dementia and depression.

The studys lead author Dr Suzanne Hurst said: "Identifying foods or dietary supplements that specifically support the desire to exercise daily will enable an individual to adhere to an exercise programme and maintain and active and healthy lifestyle."

And she found that drinking blackcurrant juice one hour before exercise supports positive affective responses during a low impact walking exercise in healthy sedentary adults.

The blackcurrants themselves were grown in New Zealand - and because of the Southern Hemispheres intense UV light, this produces unusually high levels of protective and health-giving nutrients compared with berries grown elsewhere.

The key ingredients are anthocyanins, pigments in the fruit's skin responsible for their dark purple colouring, which belong to a group of flavonoids called polyphenols and possess high levels of antioxidants.

The participants - a group of male and female adults aged between 20 and 59 - were given either blackcurrant juice or a placebo an hour before they were asked to walk on a treadmill.

The average time walked by those whod taken blackcurrants was 11 minutes longer than those who hadnt.

While only 10 percent of those whod had the placebo walked a distance greater than 10km - compared with 30 percent of participants in the blackcurrant group.

The treadmill walkers whod had blackcurrants also reported lower exertion scores - and higher overall mood scores - than those whod had the placebo. Test subjects also underwent a blood test both before and after the experiment.

And its here they noted a huge decrease in something called monoamine oxidase-B, or MAO-B, activity - something they believe could help fight neurological diseases like dementia.

Dr Hurst, of the New Zealand Institute for Plant & Food Research, says: "We found that plasma collected 1 hour after blackcurrant consumption showed a dramatic acute decline - 90 percent - in platelet MAO-B activity, which was still detectable in participants plasma once they had stopped exercise.

"The pharmacological inhibition of brain MAO-B activity has been used to treat those diagnosed with neurological diseases and depression, potentially through their neuroprotective properties in reducing the metabolism of monoamines."

The findings were reported in the Journal of the International Society of Sports Nutrition and they have been welcomed by Nicki Bundock, of Surrey-based firm CurraNZ, the UKs leading supplier of New Zealand blackcurrants supplements.

Nicki explained: "Regular exercise is one of the best ways to reduce your chances of health problems like heart disease or type 2 diabetes. But if youre not an active person, starting an exercise plan and actually sticking with it can be incredibly difficult.

Studies have shown more than half of us drop out of exercise plans after just six months, reverting to inactive lifestyles. And its therefore vital we find ways to make exercise more tolerable and enjoyable.

This study suggests blackcurrant supplements can boost time spent exercising while also making it feel easier and more pleasurable. And the less stressful exercise is, the more likely it is to become a habit.

"The fact the study also suggested benefits to neurological health make it even more welcome."

Previous studies have also demonstrated the positive effect of blackcurrants on blood sugar.

A clinical trial carried out at the University of Aberdeen showed the fruit could affect how the body breaks down carbohydrates and sugars, reducing the amount of sugar that ends up in the bloodstream after a person eats a meal.

Another fruit found to have a positive impact on blood sugar is guava.

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Type 2 diabetes: Eating this superfood could help fight the condition - Express

Visceral fat is stored within the abdominal cavity, and as such, can build up around many vital organs in the body, including the pancreas, liver and intestines. If a person has too much visceral fat, their risk of serious health conditions, such as type 2 diabetes and cardiovascular disease, is increased. But the good news is, visceral fat is extremely receptive to lifestyle measures such as eating well, exercising, sleeping and minimising stress day to day. While there isnt a single food that can get rid of visceral fat there are certain foods that will play a role in reducing overall body fat levels, helming to control the stress hormone cortisol (which can contribute to visceral fat) and help to keep appetite levels under control.

Ruth Tongue, nutritionist at FOGA, recommended five foods to include in your diet.

Many studies have shown people with abdominal obesity had reduced visceral fat levels when fibre was introduced into their diet.

Ruth advised: For a quick way to boost your fibre, I would recommend the FOGA Plantshakes, which are a delicious rang of instant-plant-based smoothies that contain at least 3g of fibre per serving.

There are so many reasons why eating plant foods will help to keep visceral fat levels under control, according to Ruth, one of which being the effect that polyphenols (the anti-oxidant substances found in plant foods) have on the release of sugar into the blood after eating.

She explained: We know that people who have better blood sugar control are less likely to have abdominal fat.

Eat a range of different coloured fruit and veggies throughout the day to keep your intake of polyphenols as diverse as possible.

Not probiotics which are the healthy bacteria found in their trillions in the gut, but the food that they feed on - prebiotics.

Ruth said: These types of fibre found in all plant foods but particularly in foods like onions, garlic, leeks, bananas and asparagus help to keep the gut microbiome thriving - in turn we know that people with a more diverse microbiome have lower levels of visceral fat.

A veggie-based stir fry is a great way to get tons of these probiotics into your diet, or if you want to start the day with a healthy shake - blend a FOGA Plantshake with your favourite milk and perhaps a handful of almonds for an extra prebiotic fix.

It may sound counter intuitive that eating more fat can reduce fat in the body, said Ruth, but eating a diet rich in MUFA (monounsaturated fatty acids) found in foods like avocado, olive oil and nuts, has been shown to reduce central fat storage.

She added: Avocados are so versatile - snack on half an avocado with a little lemon, chilli and salt, blend half in a smoothie for a delicious creaminess or whizz up with some soy sauce, ginger and a little honey for an Asian inspired dip.

Its been suggested the calcium found in dairy products has a direct effect on the reduction of abdominal fat - in fact a study of dieters found that in people given either calcium supplements, or natural yogurt daily, the yogurt eaters had great fat loss, and more of it was from the tummy area.

Ruth said: Natural yogurt is a filling snack at any time of the day - add some berries and seeds for a perfect start to the day or mix with cucumber and mint for a low-fat alternative to your shop bought Tzatziki.

So how can you tell if you have high levels of visceral fat?

Ruth advised: The simplest way to tell if you have visceral fat is to measure your waist - measure at the belly button level - In women, a waist circumference of 35 inches or larger is generally considered a sign of excess visceral fat. In men, its 40inches.

When it comes to an overall diet to follow to get rid of visceral fat, studies have proven the keto diet to be effective.

Link:

How to get rid of visceral fat: Five of the best foods to reduce the dangerous belly fat - Express