WARNING LETTER
Beeyoutiful.com, LLC
MARCS-CMS 613682 —
July 12, 2021
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Steven M. Tallent
Beeyoutiful.com, LLC
100 Huddleston Street
Centerville
,
TN
37033
United States
Issuing Office:
Office of Human and Animal Food Operations-East
United States
WARNING LETTER
July 12, 2021
RE: 613682
Dear Mr. Tallent:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at Internet address www.beeyoutiful.com in April and May 2021, and has determined that you take orders there for the products Vitex w/ Dong Quai, Berry Well, Cranberry Power Cleanse, Tummy Tuneup, Colostrum Transfer Factor, Methylated Folate, Prostate Health— Clinical Strength, D3, Vitamin K2 + D3, Dino Bones, Dynamic Duo A + D, Liquid D3, BBetter, Gentle C, CoQ10, Glucosamine/MSM, Bone Ami, Bio B12, Liquid B12, Bromelain, Magnesium Citrate, Omega-3, Odorless Garlic, Selenium Secure, Biome Blast (Yeast Assassin), and Caprylic Acid. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s Internet home page at
www.fda.gov.
Examples of some of the claims observed on your www.beeyoutiful.com website that provide evidence that your products are intended for use as drugs include:
“Vitex w/ Dong Quai”
On the product page, under the Product Description tab:
“[H]eadaches depression…constipation…are all eased by this wonderful herb.”
“Uterine fibroids, fibrocystic breasts, and endometriosis are also the results of estrogen-dominance…Beeyoutiful’s Vitex addresses these mid-life problems.”
“Berry Well”
On the product page, under the Product Description tab:
“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.”
“Raw honey…delivers a rich supply of live enzymes required to help body systems fight colds and respiratory infections of all kinds.”
“Bee propolis and Organic Echinacea root extract -- both considered powerful, natural antibiotics.”
“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.) And the potassium in raw vinegar helps cells fight bacteria and viruses.”
On the product page, the link to the article,
Our Family Miracle:
“No pharmaceutical currently on the market has been able to match the Elderberry’s ability to combat viruses and prevent their recurrence.”
“Propolis [an ingredient in the firm’s Berry Well]…some people call it “Bee Antibiotic”
White blood cells (phagocytes) serve as the body’s primary defense mechanism against bacterial infections…The same white blood cells are responsible for influencing production of antibodies which will wipe out harmful bacteria. Propolis has been found to initiate the activity and cleansing action of these lifesaving white blood cells.”
“…other fantastic ingredients in BerryWell, honey supports healing on many levels…raw, unfiltered honey…used by many to help alleviate the symptoms of severe allergies and asthma”
“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.”
On the product page, the link to the article,
When Your Family Gets Sick:
“Colds and upper-respiratory viruses get specific remedies around here…out comes the Berry Well”.
“If I have any inkling that we’ve been exposed to a stomach virus…we all immediately start taking Berry Well and Tummy Tune Up…Take it a few times per day as prevention, or as often as every two hours when symptoms are present.”
On the product page, the link to the article,
Swine Flu: Prevention and Treatment:
“[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.”
“[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. It contains BerryWell, Vitamin D3, Odorless Garlic, Tummy Tuneup, Ultimate Defense and Colostrum Transfer Factor.”
“Cranberry Power Cleanse”
On the product page, in the Product Description section:
“[C]ontains the herb uva ursi, long used for its healing powers over UTI's, cystitis, and kidney stones.”
“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.”
“Tummy Tuneup”
On the product page, under the Product Description tab in the section “How it Works,” your website states:
“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. If you're on an anti-yeast program, this pro-biotic is also an excellent accompaniment for Beeyoutiful's Yeast Assassin™ because a strong population of good bacteria is crucial to help combat yeast and fungal overgrowth.”
On the product page, the link to the article,
Pre-Natal Preparation:
“Tummy Tuneup…protecting against harmful bacteria.”
“Colostrum Transfer Factor”
On the product page, under the Product Description tab:
“Colostrum…expedite the body’s natural process of wound healing…”
On the product page, the link to the article,
How Now? From the Cow:
From the “How Does It Work?” section of the article:
o “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.”
From the “How Does It Help?” section of the article:
o “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…”
From the “How Do You Change the Past?” section of the article:
o “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.”
o “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.”
o “Colostrum…may also accelerate the healing of injuries…”
“Methylated Folate”
On the product page, under the Product Description tab:
“Folate is well known for its role in …helping to prevent disorders such as Down Syndrome, Spina Bifida…early miscarriages.”
“Folate’s role…plays a role in discouraging…colon disorders.”
“[T]hose who can benefit from Methylated Folate are those…with mental or neurological disorders…”
“Prostate Health*—Clinical Strength”
On the product page, under the Product Description tab:
“Clinical Strength Prostate Health includes three ingredients…Saw Palmetto, Lycopene, and Beta-Sitosterol. Saw Palmetto Extract has shown in several studies to be effective in treating enlarged prostate by shrinking the inner lining of the prostate…”
“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.”
“In addition, Clinical Strength Prostate Health
TM
contains vitamin D3 which has been shown to encourage prostate cancer cells to either adapt to the organ cell functions or commit cellular suicide.”
“Low levels of zinc [an ingredient in the firm’s Prostate Health*—Clinical Strength] have been found in those with low testosterone levels and subsequently prostate cancer. So supplementing with zinc is suggested to be beneficial in preventing prostate cancer.”
“[T]here has been significant data to link low selenium [an ingredient in the firm’s Prostate Health*—Clinical Strength] levels to an increased risk for prostate cancer.”
“Stinging Nettles[an ingredient in the firm’s Prostate Health—Clinical Strength]…is also known as an anti-inflammatory that can decrease the size of an enlarged prostate.”
“Pumpkin seed oil[an ingredient in the firm’s Prostate Health—Clinical Strength]… can help to decrease an enlarged prostate by inhibiting hormonal activity responsibility [
sic
] for enlargement, decrease inflammation…”
“Tumeric [sic] [an ingredient in the firm’s Prostate Health*—Clinical Strength] has been shown in studies to reduce the risk of prostate cancer.”
“With the benefits that can help relieve an enlarged prostate and prevent/decrease the risk for prostate cancer…while helping to avoid…chronic diseases…”
“D3”
On the product page, under the Product Description tab (in the “Why So Important?” section on your website):
“Vitamin D…key in caring for osteoporosis, rickets, osteomalacia, and osteopenia.”
“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!”
“…D3 may help work against cancer.”
“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…”
“Vitamin K2 + D3”
On the product page, under the Product Description tab:
“…Vitamin K is even used to treat osteoporosis before turning to prescription drugs.”
“Vitamin K may help…to eliminate the risk for caries and other dental problems.”
“One study found that heart disease was literally cut in half in those taking Vitamin K.”
“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…”
“Vitamin D3 is an immense contributor…helping to stave off contagious ‘bugs’ of all sorts.”
“Dino Bones”
On the product page, under the Product Description tab:
“Deficiency in Vitamin D has been linked to 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, Chronic Fatigue Syndrome, and autoimmune diseases.”
“…Vitamin D3 is …helping stave off ‘bugs’ of all sorts. Flus, colds, other viral and bacterial upsets…”
“Dynamic Duo A + D3”
On the product page, under the Product Description tab:
“Vitamin D is …helping to stave off ‘bugs’ of all sorts…is key in caring for such problems as osteoporosis, rickets, osteomalacia, and osteopenia.”
“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!”
“…D3 may help work against cancer.”
“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…”
“…[V]itamin A [an ingredient in the firm’s Dynamic Duo A + D3] is a warrior for the eyes, protecting them from blindness, night blindness, and other problems such as keratomalacia, and xeropthalmia. It is also very helpful for diabetics suffering from problems with the retina.”
“Liquid D3”
On the product page, under the Product Description tab:
“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!”
“…D3 may help work against cancer.”
“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…”
“…vitamin D3 is an immense contributor...helping to stave off ‘bugs’ of all sorts. Flus, colds, other viral and bacterial upsets…”
“B-Better”
On the product page, under the Product Description tab:
“…commonly known uses for the B complex, would be folic acid [an ingredient in the firm’s B-Better] during pregnancy to prevent spina bifidia [sic] and downs syndrome disorders (and many other disorders…”
“…regular intake of B Vitamins is beneficial to prevent cataracts, migraines, anemia, birth defects, dementia, depression, and even some cancers”
“It has shown to…increase the rate of healing in wounds”
“…regular intake has seen to help to decrease chances of heart disease, stroke or arterial disease…”
“Gentle C”
On the product page, under the Product Description tab:
“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.”
“Vitamin C is an excellent aid for those who suffer from gout…It is also frequently used as a type of chelating agent for minerals when deposits in the body are causing damage (such as calcium deposits in atherosclerosis).”
“CoQ10”
On the product page, under the Product Description tab:
“…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.”
“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…”
“Glucosamine/MSM”
On the product page, under the Product Description tab:
“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…”
“For even more significant relief, Beeyoutiful®’s supplement adds MSM, a natural sulfur compound, to aid in pain reduction. MSM blocks the transmission of pain signal impulses in nerve fibers, and it alters cross-linked collagen, resulting in less scar tissue and diminished degeneration of the joints.”
“Bone Ami”
On the product page, under the Product Description tab:
“Bone AmiTM bone health tablets can help you reduce the pain associated with arthritis…when you take it daily as…arthritis supplement.”
“Bio B12”
On the product page, under the Product Description tab:
“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…”
“Liquid B12”
On the product page, under the Product Description tab:
“…[B-12] seems to help prevent heart disease by lowering homocysteine levels…it also…protects against anemia…”
“Regular intake of B-12 has also shown to…decrease depression…”
“…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.”
“Bromelain”
On the product page, under the Product Description tab:
“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.”
“Some research shows bromelain to have anti-tumor properties.”
“Magnesium Citrate”
On the product page, a link to an article, A Magnificent Solution for Colon Health:
“So most of us are getting inadequate magnesium plus too much calcium. This imbalance has been linked to high cholesterol, high blood pressure, and ultimately, to heart disease. A variety of other problems also, have been linked to magnesium deficiency:…phobic anxiety, depression…”
“As we age, we get…insomnia, Restless Leg Syndrome…Maybe the reason isn’t just that we’re ‘getting older’, but that we need more magnesium!”
“Omega-3”
On the product page, under the first Product Description section:
“Omega 3’s have been shown to play a role in helping to reduce the risk OF [sic] heart disease…help decrease inflammation.”
On the product page, under the Product Description tab (in the “Who can benefit from taking Omega 3?” section):
“1. Inflammatory diseases or inflammation in the body – studies have shown it helps to decrease inflammation by reducing cytokine production 2. Cardiovascular Health – studies show it can help to decrease excessive clotting, lower lipids, decrease or help stop thickening of the arteries 3. Diabetics – stimulates the body to produce and release leptin which thus improves the body’s ability to respond to insulin 4. Cognitive function – including both dementia/Alzheimer’s and Depression/Mental disorders…”
“Odorless Garlic”
On the product page, a link to an article, Garlic,
The Natural Plant Antibiotic:
“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…”
“Selenium Secure”
On the product page, under the Product Description tab:
“Studies on selenium have shown that it may provide protection against many different cancers…”
On the product page, a link to an article,
The Selenium Difference:
“Selenium studies have shown that it protects against stomach, breast, esophageal, prostate, liver, and bladder cancers…
“Selenium-deficient patients are known to experience mutations of the influenza virus, often resulting in severe lung damage and a worsened case of the flu.”
“…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…”
“Biome Blast (Yeast Assassin)”
On the product page, under the Product Description tab:
“Excess yeast can cause all sorts of problems including digestive and gastrointestinal disorders, rashes, fungal outbreaks and infections and of course the dreaded ‘yeast infection’…dealing with fungal problems on a systemic level is faster and much more effective than dealing with them topically…”,
On the product page, a link to an article,
Rise Up Against Yeast:
“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…Pau d’arco…known to be resistant to fungus growth…Black walnut hulls…another known ally in the candida war (and in expelling parasites!)…Oregano oil rounds out this awesome foursome with it anti-fungal, anti-viral, anti-bacterial, and anti-parasitic powers.”
“Caprylic Acid”
On the product page, under the Product Description tab:
“Beeyoutiful®’s Yeast Assassin Lite
TM
Caprylic acid…has been found to exhibit anti fungal [
sic
] properties…”
Your Vitex w/ Dong Quai, Berry Well, Cranberry Power Cleanse, Tummy Tuneup, Colostrum Transfer Factor, Methylated Folate, Prostate Health—Clinical Strength, D3, Vitamin K2 + D3, Dino Bones, Dynamic Duo A + D, Liquid D3, B-Better, Gentle C, CoQ10, Glucosamine/MSM, Bone Ami, Bio B12, Liquid B12, Bromelain, Magnesium Citrate, Omega-3, Odorless Garlic, Selenium Secure, Biome Blast (Yeast Assassin), and Caprylic Acid products are not generally recognized as safe and effective for the above-referenced uses and therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § § 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” mean directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your Vitex w/ Dong Quai, Berry Well, Cranberry Power Cleanse, Tummy Tuneup, Colostrum Transfer Factor, Prostate Health—Clinical Strength, D3, Vitamin K2 + D3, Dino Bones, Dynamic Duo A + D, Liquid D3, Gentle C, CoQ10, Bio B12, Liquid B12, Bromelain, Magnesium Citrate, Omega-3, Odorless Garlic, Selenium Secure, and Biome Blast (Yeast Assassin) products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Vitex w/ Dong Quai, Berry Well, Cranberry Power Cleanse, Tummy Tuneup, Colostrum Transfer Factor, Prostate Health—Clinical Strength, D3, Vitamin K2 + D3, Dino Bones, Dynamic Duo A + D, Liquid D3, Gentle C, CoQ10, Bio B12, Liquid B12, Bromelain, Magnesium Citrate, Omega-3, Odorless Garlic, Selenium Secure, and Biome Blast (Yeast Assassin) fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to the U.S. Food and Drug Administration, Zada L. Giles, Compliance Officer, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have any questions with regard to this letter, please contact Zada L. Giles, at (615)366-7985 or via email at
ORAHAFEAST5FirmResponses@fda.hhs.gov.
Sincerely,
/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Food Operations-East
Content current as of:
07/20/2021
Regulated Product(s)
Drugs
Food & Beverages