Beeyoutiful.com, LLC
FDA issued a warning letter to Beeyoutiful.com, LLC (Steven M. Tallent) on July 12, 2021, after reviewing the company's website and finding that 26 dietary supplement products were marketed with disease-treatment and cure claims that legally classified them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. The claims spanned a wide range of serious conditions including cancer, diabetes, Alzheimer's, Ebola, AIDS, autism, and multiple sclerosis, among others. FDA also found that many products were misbranded because they lacked adequate directions for use for conditions requiring licensed practitioner supervision. The company was directed to respond within 15 working days with corrective steps, and was warned that failure to comply could result in seizure or injunction.
Flagged claims (48)
The immunoglobulins go after and stop a microorganism called cryptosporidiosis, a cause of severe diarrhea. Children and adults with acute or chronic diarrhea can be helped by taking a small, white capsule of colostrum such as Beeyoutiful's Colostrum Transfer Factor.
Bone AmiTM bone health tablets can help you reduce the pain associated with arthritis…when you take it daily as…arthritis supplement.
Some research shows bromelain to have anti-tumor properties.
Raw honey…delivers a rich supply of live enzymes required to help body systems fight colds and respiratory infections of all kinds.
…regular intake of B Vitamins is beneficial to prevent cataracts, migraines, anemia, birth defects, dementia, depression, and even some cancers
[O]therwise known as BerryWell…several studies show a clearly documented connection between elderberry extract and rapid T1 cytokine production. This is part of what makes it so very effective as an immune-boosting preventative measure against viruses – it can stop the virus in its track before it takes hold.
Uterine fibroids, fibrocystic breasts, and endometriosis are also the results of estrogen-dominance…Beeyoutiful's Vitex addresses these mid-life problems.
…[B-12] seems to help prevent heart disease by lowering homocysteine levels…it also…protects against anemia…
Do you have a sports injury, trauma, arthritis and other types of swelling? Bromelain may be the right solution for you. It works by blocking metabolites that accelerate and worsen the inflammatory process.
Folate is well known for its role in …helping to prevent disorders such as Down Syndrome, Spina Bifida…early miscarriages.
Raw apple cider vinegar…increases your body's alkalinity. (Although today's diets tend to make us more acidic, an alkaline body is safer from cancer and other diseases.)
Saw Palmetto Extract has shown in several studies to be effective in treating enlarged prostate by shrinking the inner lining of the prostate…
Before you consent to taking irritable bowel prescription medicines (which do have unwanted side effects), try putting yourself on a Tummy Tuneup™ regimen for awhile.
Bee propolis and Organic Echinacea root extract -- both considered powerful, natural antibiotics.
When the body is getting enough D to go around, it is used liberally by many cells that are able to make calcitriol and use its cancer-fighting properties!
…Vitamin K is even used to treat osteoporosis before turning to prescription drugs.
Studies have shown that those who can benefit the most from Methyl B12 are…people suffering from Autism Spectrum Disorder, Alzheimer's or Parkinson's diseases, or neurological disorders such as Bell's Palsy or Multiple Sclerosis…
If you already have cancer, colostrum is a powerful ally in the fight. It contains phytic acid which inhibits iron from reaching and nourishing cancer cells. It also isolates and starves fungi and viruses which would otherwise thrive…
Colds and upper-respiratory viruses get specific remedies around here…out comes the Berry Well.
Studies have show [sic] that when men take lycopene [an ingredient in the firm's Prostate Health*—Clinical Strength] they have a decreased risk for prostate cancer and other prostate ailments.
Vitamin D…key in caring for osteoporosis, rickets, osteomalacia, and osteopenia.
Selenium studies have shown that it protects against stomach, breast, esophageal, prostate, liver, and bladder cancers…
With the benefits that can help relieve an enlarged prostate and prevent/decrease the risk for prostate cancer…while helping to avoid…chronic diseases…
In addition, Clinical Strength Prostate HealthTM contains vitamin D3 which has been shown to encourage prostate cancer cells to either adapt to the organ cell functions or commit cellular suicide.
While commonly prescribed pain killers such as ibuprofen and specific arthritis pain inhibitors can mask the ache of joints rubbing together, they don't promote healing and can have unwanted side effects…On the other hand, glucosamine relieves discomfort while it helps to restore-by…repairing…cartilage, tendons, and other connective tissues…
…adequate selenium…protects against the dreaded 'cytokine storm' many researchers think is responsible for the severe respiratory tract damage and many of the deaths in…SARS flus…
No other herb comes close to the multiple system actions of garlic, its antibiotic activity…It has been successfully used to treat all of the following common conditions:…high blood pressure…high cholesterol…active bacterial infections…gastrointestinal infections…sinus infection…infections of eye, nose, and ears…athlete's foot and surface skin infections…prevention of blood infections such as gangrene…amebic dysentery…
Fortunately, studies suggest that taking colostrum offers hope for stopping communicable diseases, whether Ebola, bird flu, AIDS, SARS, or the host of new antibiotic resistant illnesses on the rise.
No pharmaceutical currently on the market has been able to match the Elderberry's ability to combat viruses and prevent their recurrence.
[W]e have put together a convenient and significantly discounted Anti-Flu package. Included in this package are what we believe to be our most effective and beneficial products to arm and protect you and your family from any potentially dangerous flu.
Beeyoutiful®'s Yeast Assassin LiteTM Caprylic acid…has been found to exhibit anti fungal [sic] properties…
One study found that heart disease was literally cut in half in those taking Vitamin K.
Echinacea [an ingredient in the firm's Berry Well]... Other components in Echinacea have been shown to have antibacterial and fungicidal activity. These elements have been found to slow down the spread of the bacteria rather than kill them outright like an antibiotic.
Consider the diseases that can be combated with colostrum….campylobacter, Candida and E. coli, clostridium (botulism), food poisoning, helicobacter pylori, listeria, rotavirus, salmonella, shigellosis, and streptococcus…colostrum counters leaky gut and irritable bowel syndrome, colitis, ulcers, chronic fatigue, diabetes, autoimmunity, rheumatoid arthritis, lupus, and cancers, and that it may even inhibit schleroderma [sic], fibromyalgia, and multiple sclerosis.
There are significant findings that those suffering from Parkinson's are low in CoQ10, and therefore can benefit from supplementation, especially earlier in the disease stage. The improvements in their overall symptoms were marked…
Propolis [an ingredient in the firm's Berry Well]…some people call it "Bee Antibiotic"
Studies on selenium have shown that it may provide protection against many different cancers…
Cranberries contain proanthocyanidins that can prevent the adhesion of certain bacteria (including E. coli) associated with urinary tract infections to the urinary tract wall. The antiadhesion properties of cranberry may also inhibit the bacteria associated with gum disease and stomach ulcers.
Health complications…directly involved with the problem of inflammation -- such as cardiovascular disease, high blood pressure, stroke, diabetes, and cancer (among many others) -- have benefited greatly from vitamin C's ability to help reduce inflammation.
Yeast Assassin is a potent combination of herbs known to be mortal enemies of candida: caprylic acid, pau d'arco, black walnut, and oregano oil. Caprylic acid…has anti-fungal as well as some anti-bacterial and anti-viral properties…
[H]eadaches depression…constipation…are all eased by this wonderful herb.
[C]ontains the herb uva ursi, long used for its healing powers over UTI's, cystitis, and kidney stones.
Blood sugar problems, low back pain, high blood pressure, type I and type II diabetes, Alzheimer's disease, kidney stones, psoriasis, depression, seasonal affective disorder, fibromyalgia and chronic fatigue syndrome and auto-immune diseases have all been linked with low levels of vitamin D…
…CoQ10 can be beneficial for a number of conditions….those suffering from Congestive Heart Failure have seen a significant decrease in symptoms and the severity of symptoms.
Vitamin K2 has a very crucial role in the nervous system in production of sulfatides, a lack of which can cause significant neural symptoms. This is especially seen in patients that suffer from seizures or Alzheimer's Disease. Thos [sic] treated with Vitamin K2 often saw either dramatic improvement of symptoms or elimination of the symptoms altogether…
…especially those suffering from dementia, have been encouraged to take B-12 in conjunction with folate to help decrease the likelihood of their symptoms worsening.
Berry Well is a practically miraculous combination of the following:
[P]urple elderberries …. [t]he anti-viral powers of these immune system enhancers attack many strains of influenza A and B -- without the side effects or complications of a flu shot.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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