FDA, FTC Warn 10 Companies Illegally Selling Dietary Supplements Claiming to Treat Diabetes
For Immediate Release: September 09, 2021
Today, the U.S. Food and Drug Administration and the Federal Trade Commission posted warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent diabetes, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.
The warning letters were issued to: Live Good Inc.; Pharmaganics LLC; Lysulin Inc.; Nuturna International LLC; Phytage Labs; Ar-Rahmah Pharm LLC; Metamune Inc.; Holistic Healer & Wellness Center Inc.; Radhanite LLC; and Aceva LLC.
“More than 34 million Americans— just over 1 in 10 people— are living with diabetes. Dietary supplements that make fraudulent claims to treat diabetes are unapproved new drugs that could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments,” said Cara Welch, Ph.D., Acting Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “The FDA is committed to protecting U.S. consumers from products and companies that make unlawful claims to treat or prevent diabetes, and we’ll continue to hold companies accountable by alerting the public about products that place consumers at risk.”
Under the FD&C Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns. The FDA advises consumers to talk to their doctor, pharmacist or other health care provider before deciding to purchase or use any dietary supplement or drug. Also, if claims sound too good to be true, they probably are.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by 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 nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Spore Mushroom Supplements Review – High Quality Products?
Mushrooms have existed for many years. Over 50,000 species of mushrooms are grown in different parts of the world. What comes to mind when you hear the term “functional mushroom”? Is it a white button that you purchase at a local grocery store? Functional mushrooms are rare mushrooms containing a plethora of nutrients, vitamins, and minerals. From boosting the immune system to promoting heart health and cognitive functions, these mushrooms have many benefits.
Spore Intelligent Functional Mushroom Formulations
Here’s a review of Spore’s functional mushroom formulations. Let’s get started!
Mike’s Mushroom Mix
If you’re looking for an all-natural health formula that replenishes your body with vitamins, minerals, and nutrients for your total wellbeing, Mike’s Mushroom Mix may be a suitable choice. The supplement is a blend of 10 mushrooms that offer anti-inflammatory and antioxidant benefits, support the immune system, promote liver function and overall health. The creator, Mike, developed this comprehensive formula from the highest quality mushroom ingredients. Mike’s Mushroom Mix acts as a nutritional powerhouse for optimizing body functions and performance. Considered safe for individuals of all ages, Mushroom Mix promotes mental alertness while reducing brain fog. Some active ingredients in this formula include the following:
Maitake: Containing polysaccharides, triterpenes, and bioactive chemicals, Maitake is an immune booster that offers you an extra dose of energy.
Reishi: The antioxidant-rich ingredient also boosts immunity and helps to relieve stress. Reishi is used to treat various health conditions.
Shiitake: Loaded with eight essential amino acids, Shiitake reduces inflammation, promotes cardiovascular health, and supports blood sugar levels.
Turkey Tail: The functional mushroom is anticarcinogenic and promotes a healthy gut biome.
Apple Cider Vinegar: Rich in polyphenol, Apple cider vinegar improves heart health, boosts digestion and weight loss.
Other ingredients: Other ingredients include KSM-66 Ashwagandha, Boswellia Serrata, black pepper fruit extract, garlic, burdock root, calcium, cayenne pepper, chamomile, chromium, DIM, Ubiquinone, fenugreek, elderberry, garcinia Cambogia, Gingko Biloba, among others.
Want an extra dose of energy to see you through the day’s activities? You might find Spore’s Energy Performance a good option. With this energy blend, your energy level is at its peak. Formulated from Cordyceps and Maitake mushrooms and supported with ingredients like Green Tea Extract, Guarana, and Panax Ginseng, this supplement will elevate your energy level. Daily consumption of 2 capsules can increase endurance and energy production, reduce aging, boost metabolism, and decrease fatigue.
Below are some of the constituents of this product:
Cordyceps: This medicinal mushroom boost exercise performance, reduce weight, support cholesterol levels, increase sex drive and lower high blood pressure.
Maitake: Composed of Vitamin B and C, antioxidants, amino acids, and potassium, Maitake supports blood pressure and immunity. The fungus also lowers the growth level of some tumors.
Green Tea Extract: Considered a healthy beverage, green tea extract prolong longevity, enhance brain function, and lowers fat in the body. It offers anti-aging benefits and is quite effective against cardiovascular disease and type 2 diabetes. As an antioxidant, it helps to fight free radicals.
Guarana Extract: Guarana fruits and seeds are loaded with stimulants such as theobromine and caffeine. The extract enhances focus, helps the digestive system, relieves constipation, improves the look of your skin, and promotes vision. Guarana extract possesses antibacterial and anticancer properties.
Other ingredients include Panax ginseng and turmeric root extract. The combined effects of these ingredients include increased energy levels, improved sexual drive, management of oxidative stress, etc.
People often focus on dieting and exercise regimens to maintain a healthy body while paying less attention to the brain. But, recently, there’s been the development of various supplements to improve brain health. Focus Performance is a nutritional supplement that boosts mental health and alertness. From being an energizer to supporting adrenal, memory, and cognitive functions, Focus Performance is a powerhouse for improving general brain health. The effectiveness of this formula is a result of its brain-boosting ingredients such as Ginkgo Biloba, Lion’s mare, Ashwagandha, and Cordyceps.
Ginkgo Biloba: This ingredient helps in eliminating toxins from the body. The antioxidant-rich cures blood disorders while promoting circulation and memory.
Lion’s mare: The medicinal mushroom proves effective in increasing mental sharpness, focus, and overall brain health. Based on studies, Lion’s mare reduces the possibility of dementia, nerve damage, and depression.
Ashwagandha: It’s used as traditional medicine due to its powerful healing ability. In addition, Ashwagandha is clinically proven to decrease stress, supports balance, brain, and cardiovascular health. Other benefits associated with this ingredient include an increase in libido and sexual health improvement.
Cordyceps: The rare mushroom is loaded with energy-boosting constituents. Cordyceps increase immune functions and organ performance.
Using Focus Performance twice daily for 30 days can reduce aging, prevent brain fog, relieve stress and inflammation in the body. Unlock mental clarity and performance with this supplement.
Protect + Defend
Protect + Defend claims to improve overall health and well-being by containing a wide array of vitamins, minerals, and antioxidants. The revolutionary formula supports immunity and strengthens the body’s natural defense system. Sourced organically, Protect + Defend is a holistic supplement scientifically proven to defend the body against infections. Besides Reishi and Maitake, Protect + Defend contain other ingredients such as:
Vitamin C: The essential vitamin is found in many fruits like oranges and other types of citrus. Vitamin C helps growth, repair body tissues, and promote development in the body. It’s also beneficial to the eyes, heart, and respiratory system.
Vitamin D: The fat-soluble vitamin facilitates the absorption of calcium, phosphate, and magnesium. It also helps other biological processes.
Zinc: Besides iron, zinc is another mineral present in large quantities in the body. While we don’t produce this mineral, we can get zinc from our diet or supplements. From protein synthesis to DNA production, immunity, and healing of wounds, zinc offers many benefits to the body.
Elderberry: The dark purple berry contains many antioxidants and vitamins, beneficial to the immune system.
Are you looking to relieve stress and rejuvenate after a hard day’s work? Then, a mood relaxant will be an ideal option. Chill Out is a blend of Reishi mushroom and natural herbs such as valerian root, lemon balm, and chamomile. This dietary supplement gives you that relaxing feel while helping you sleep at night. Among the various ingredients that constitute Chill Out, Reishi is the most powerful. Considered the mushroom of immortality, Reishi combines with other herbal ingredients to relieve anxiety and cure insomnia. Let’s consider some benefits of these ingredients.
Lemon Balm: The lemon-scented herb doubles as a sedative that helps improve mood. It has anti-inflammatory properties and claims to support blood sugar levels.
Passion Flower: The vine was used in ancient times to manage stress and cure insomnia and anxiety. Popular in North America, the Passionflower has wide use in traditional medicine.
Valerian Root: Traced to ancient Greece, Valerian root promotes sleep while helping relaxation, treating anxiety and digestive problems.
Chamomile: Chamomile is a mild sedative and potent herb that makes you calm, feel relaxed, and promote digestive functions. The daisy-like plant is native to Egypt and is believed to be a gift from the Egyptian god.
If you’re looking to shed some excess weight, you should consider a metabolic boost. While exercise helps you lose weight, it won’t be a bad idea to try a nutritional supplement that increases your fat-burning process. The formula will help put your appetite in check while reducing your cholesterol and sugar levels. Metabolic Boost is packed with various ingredients, including green coffee, chromium, niacin, Cordyceps, and Maitake. These ingredients combined promote cardiovascular health, lowers weight, increases cellular energy and respiratory functions. Other ingredients include:
Cayenne Pepper: Cayenne pepper is a species belonging to the nightshade family. It’s a potent spice known for its medicinal benefits. It helps relieve pain, reduce appetite, boost metabolism, reduce high blood pressure and appetite. In addition, cayenne pepper aids digestion.
Green Coffee Extract: Green coffee extract is derived from unroasted coffee beans, features chlorogenic acids and caffeine to support inflammation, increase energy production, among others.
Garcinia Cambogia: The tropical fruit abundant in Indonesia is very sour and can’t be eaten raw. Also known as Pot Tamarind, Garcinia Cambogia is usually cooked and used as an ingredient in foods. The fruit has an increased amount of hydroxy citric acid (HCA), which supports weight loss.
Raspberry Ketones: Responsible for the deep red pigment in raspberries, Raspberry Ketones help increase energy levels when low.
Vitamins: Vitamin B1, B2, B3, and D3 improve gut, skin, and brain functions. Vitamin B3, a water-soluble vitamin, supports cholesterol level and a healthy heart. Vitamin B2 aid assimilation and digestion of nutrients.
As you get older, your sexual drive and performance reduce. With enhancement pills, you can ramp up your testosterone levels and sperm count. Men’s Vitality is made effective by functional mushrooms like Cordyceps and Lion’s mares. These mushrooms are supported by plant extracts such as Ashwagandha, Fenugreek, Mucuna Pruriens, etc. Here are some of the beneficial effects of these ingredients:
Black Pepper Fruit Extract: The fruit extract is derived from black peppercorn and is used as a seasoning in foods. Often called piperine, black pepper fruit extract increases absorption when taken with other supplements.
DIM: Found in broccoli and cabbage, Diindolylmethane (DIM) improves immunity, boosts metabolism, and promotes healthy hormone levels.
Longjack Root: This root which dates back centuries, is widely used in traditional medicine to boost sexual health, exercise, and fat loss.
Mucuna: Mucuna is extracted from the velvet bean. It has also been in existence for years. It helps to enhance focus, sexual drive, and mood.
Fenugreek: Mostly found in India, fenugreek is commonly used as a spice. Fenugreek seeds support lactation and blood sugar levels. It also boosts sexual health in men.
The heart is an essential part of the body that needs utmost care and attention. Using a heart health supplement can increase the overall health of an individual. If you’re looking for a blend that promotes heart functions, you might want to consider Cardiovascular Performance. The supplement is formulated from functional mushrooms like Reishi, Chaga, Maitake, and Shiga. These mushrooms are complemented by powerful ingredients such as CoQ10, L-Taurine, Hawthorn Berry, B Vitamins, among others. From preventing oxidative stress to promoting circulation and tissue growth, cardiovascular performance is one of a kind. Below are how these ingredients help the overall health:
Hawthorn Berry: The small red berry is primarily grown in the Northern hemisphere. It’s packed with antioxidants to reduce free radicals, inflammation, cholesterol, and high blood pressure.
L-Theanine: The amino acid is abundant in mushroom species, black and green teas. L-Theanine has a distinct flavor that helps to sweeten some foods. It’s used alongside other supplements to aid relaxation, sleep and focus.
L-Taurine: L-Taurine is concerned with nerve growth, blood pressure, and cardiovascular health.
Osteo Performance has been found to support bone health. For an aging person, this supplement will be beneficial as it boosts joint functions. Osteo Performance makes you active and increases flexibility. With this formula, you can say goodbye to aches and soreness while living your best life. The blend consists of the following:
Burdock Root: Burdock root is both used as herbal infusions and eaten as a vegetable. Containing quercetin and luteolin, burdock root support digestion, inflammation, and blood sugar.
Calcium: The essential mineral that helps to build strong bones and teeth. It also supports healthy muscles, fat burning, and blood clotting.
Other ingredients include glucosamine, loquat flower, turmeric, turkey tail, and zinc.
Ultimate Wellness Bundle
Like its name, the Ultimate Wellness Bundle is an all-around supplement that supports overall health, immunity, focus, mood, and energy production. As an all-inclusive product, the Ultimate Wellness Bundle has many ingredients that help a healthy lifestyle. Let’s consider the benefits of some of these ingredients.
Agarikon: Pegged the elixir of long life, Agarikon possesses antibacterial, antiviral, and anti-inflammatory properties that defend the body against harmful microorganisms.
Antrodia: This fungus helps liver function and heart performance. It also boosts immunity, relieves stomach problems and inflammation, reduces symptoms of diabetes and hypertension.
Other ingredients are Panax ginseng, Agarikon, apple cider vinegar, Ginkgo Biloba, turmeric, etc.
RELATED: 10 Best Liver Health Supplements to Detox and Cleanse Safely
The links contained in this product review may result in a small commission if you opt to purchase the product recommended at no additional cost to you. This goes towards supporting our research and editorial team and please know we only recommend high quality products.
Please understand that any advice or guidelines revealed here are not even remotely a substitute for sound medical advice from a licensed healthcare provider. Make sure to consult with a professional physician before making any purchasing decision if you use medications or have concerns following the review details shared above. Individual results may vary as the statements made regarding these products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease.
The Best Vitamin D Supplements to Take, According to Dietitians
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With COVID still a threat around the globe, many people are eager to boost their immune health by adding some supplements to their regular routine. Among the most popular additions to many people’s supplement regimens has been vitamin D, and with good reason. A 2020 study published in JAMA Network Open found that, among a group of 489 individuals studied, those with low vitamin D levels were 1.77 times more likely to test positive for COVID than those with sufficient vitamin D levels.
What’s more, research has found that vitamin D may promote weight loss among overweight and obese adults, has cardiovascular health benefits, and may even reduce your risk of certain types of cancer. If you want to improve your health fast, read on to discover the best vitamin D supplements on the market, according to dietitians. And if you want to improve your whole body wellbeing, check out The One Vitamin Doctors Are Urging Everyone to Take Right Now.
Nordic Naturals Vitamin D3 Gummies
Looking for an easy way to get adequate vitamin D in your diet, even if you’re pill-averse? Look no further than these vitamin D gummies from Nordic Naturals.
“They are sweetened naturally with organic tapioca syrup and cane sugar. This vitamin D supplement is also free of fillers and additives. In addition, they’re gelatin-free, non-GMO, certified vegetarian, and pretty potent as they are 1,000 IU,” explains Courtney D’Angelo, MS, RD, author at Fit Healthy Momma.
$18.66 at Amazon Buy Now
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NOW Vitamin D-3
For those who prefer their vitamins in capsule form, D’Angelo recommends NOW’s vitamin D-3 supplements, which are soy-free, kosher, and halal.
“NOW Vitamin D-3 is also a great vitamin D supplement that I recommend. These are also sweetened naturally and they do not contain artificial colors and flavors. This supplement does have gelatin, but is non-GMO,” says D’Angelo.
$4.52 at Amazon Buy Now
Metagenics Vitamin D3 5,000+ K
If you want a little more bang for your buck when it comes to your vitamin D supplement, Metagenics' combination vitamin D3 and vitamin K supplement might just be the perfect fit.
“The most effective vitamin D supplements will also have vitamin K2, which ensures that calcium can more easily go to the bones where it should be, instead of to the arteries. Personally, I recommend Metagenics vitamin D3 with K2 softgel because it is a medical-grade supplement brand that ensures purity and quality, the pills are small and easy to swallow, the amount of vitamin D is appropriate for many individuals, and the type of K2 used is more bioavailable, meaning that the body can absorb and use it more efficiently,” says dietitian and health coach Kaytee Hadley, RDN, MSNHL, CPT.
$33.80 at Amazon Buy Now
Nature Made Vitamin D3 1000 IU
If you’re looking for a budget-friendly way to increase your vitamin D intake, Nature Made’s vitamin D supplement certainly fits the bill.
“It’s a very affordable supplement that could fit into most families' budget,” says Cheryl Mussatto MS, RD, LD, author of The Nourished Brain.
“This brand is also free of gluten, artificial flavors, and colors. For better absorption, it encapsulates their vitamin D supplements with soybean oil. Nature Made has also been ranked as the number one pharmacist recommended vitamin and supplement brand and USP verified in 2020. The company has a strong reputation for the potency and dependable quality of its supplements.”
$9.99 at Amazon Buy Now
Hum Nutrition Here Comes the Sun
Worried about additives in your supplements? With Hum’s Here Comes the Sun vitamin D supplement, you don’t have to be.
“Hum supplement ingredients are clinically researched, tested and proven effective,” says Carrie Gabriel MS, RDN, owner of Steps2Nutrition. “Their vitamin D is a softgel, it is vegan, non-GMO, gluten-free, and has no artificial sweeteners or coloring added. You can take it in the morning with food and you’re good to go for the day!”
$12.00 at Hum Nutrition Buy Now
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