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WARNING LETTER

Grandma's Herbs MARCS-CMS 532853 —

Delivery Method:
UPS
Recipient:
Recipient Name
Kevin Parr
Grandma's Herbs

221 West 200 South
St. George, UT 84770
United States

Issuing Office:
Denver District Office

United States

 

  

Black HHS-Blue FDA Logo

 

Denver District Office 
P.O. Box 25087
Denver, CO 80225

 
 

 

September 15, 2017
 
 
WARNING LETTER
 
 
Via UPS Overnight
 
 
Grandma’s Herbs, Inc.
Attn: Kevin Parr, CEO
221 West 200 South
St. George UT 84770
 
 
Ref: HAF4W(DEN)-17-21-WL
 
 
Dear Mr. Parr:
                                   
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the internet address www.grandmasherbs.com in July 2017 and has determined that you take orders there for your products: Anti-Plague Formula, Aspire, Bright Eyes, Cayenne, Deeper, Deliverance, Endo Relief, Eyebright Plus, EZ Traveler, Frankincense Certerii, Frankincense Serrata, Herbal Calcium, Immune Enhancer, InsideOut, Kidney Cleansing and Strengthening, Lavender, Lemon, Lemongrass, Millenia, MyGraine, Nature’s Biotic, Nervine, Paine, Pancreas-Aid, Prostate, Slim Too, SpiceC, Super Lax, Tea Tree, Vitality and Warm Down. The claims on your website establish that the 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 home page at www.fda.gov.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Anti-Plague Formula
On the page titled Anti-Plague Formula
  • “If you are suffering with a cold, flu and/or other infectious ailments, many have found relief from this combination.”
  • "This tincture is effective at preventing and eliminating the common cold and the flu viruses."
  • "It is also good for cuts, bruises, fevers, burns and plagues. We have testimonial after testimonial of it’s [sic] effective results."
Aspire 10 ml
On the page titled Aspire 10 ml (Essential Oil)
  • “Aspire is used to bring relief from colds, bronchitis, pneumonia, sinusitis, respiratory congestion, allergy symptoms, deep pneumonia, pleurisy, asthma, and flu that have settled in the lungs.”
Bright Eyes
On the page titled Bright Eyes (Dietary Supplement)
  • “BRIGHT EYES has also been used for pink eye …”
Cayenne
On the page titled Cayenne (Dietary Supplement)
  • “[R]ebuild the tissue in the stomach and aid in the healing stomach and intestinal ulcers.”
On the page titled CAYENNE (Capsicum frutescens) – Grandmas Blog
  • "In case of a heart attack cayenne will stimulate the heart… “
  • "Cayenne will stabilize blood pressure, stop internal bleeding and help to stop a stomach ulcer from bleeding"
On the page titled Cayenne – Testimonials
  • “I am very excited with the results I have received from herbs. I have been a Diabetic for 28 years and was diagnosed with Amyotrophic Lateral Sclerosis, ALS, or Lou Gehrigs Disease about a year and a half ago. Diabetic Neuropathy was very advanced in my feet….My brother, Bert S Leany, suggested that I use Cayenne (http://www.grandmasherbs.com/daily-herbal-vitamins-minerals/cayenne.html) to stop the bleeding in my eye when I was losing the sight in it due to complication of surgery following a detached retina...I have partially regained the feeling in my feet”.
Deeper 10ml
On the page titled Deeper 10ml (Essential Oil)
  • “10 ML Pure Essential Oil It is useful for sciatica, arthritis, osteoarthritis, the pain of osteoporosis, sprains, and injuries where there is bruising and/or nerve damage.”
  • “Other important uses for Deeper are pain relief with shingles and bursitis.”
Deliverance 10 ml
On the page titled Deliverance 10 ml (Essential Oil)
  • "Deliverance is one of the most potent antiviral, antibacterial, antifungal combinations available. Its many uses include respiratory infections, sore throats, strep throats, dental diseases and infections, cold sores, canker sores, cuts, general infections, athlete's foot and toe nail fungus and infection from slivers." 
Endo Relief 10 ml
On the page titled Endo Relief 10 ml (Essential Oil)
  • “Endo Relief can have a beneficial effect on any ailment that is related to endocrine organs.”
  • "This makes Endo Relief useful for such things as diabetes, hypoglycemia, bladder and kidney infections, candida, and so much more."
  • “[A]ffects such things as the prevention of gallstones, kidney stones, arthritis, and osteoporosis”.
Eyebright Plus
On the page titled Eyebright Plus (Dietary Supplement)
  • "Bilberry has been found to help with nearsightedness..."
EZ Traveler 10 ml
On the page titled EZ Traveler 10 ml (Essential Oil)
  • “It has been used to treat anorexia.” 
Frankincense, Certerii 10ml
On the page titled Frankincense, Certerii 10ml (Essential Oil)
  • "Beneficial effect on respiratory conditions such as cough, bronchitis, and pneumonia. 10 ML Pure Essential Oil (single) Frankincense is useful for skin disorders and circulation problems."
Frankincense, Serrata 10 ml
On the page titled Frankincense, Serrata 10 ml (Essential Oil)
  • "There is a lot of scientific data around the world indicating that the anti-inflammatory properties of resin oils (frankincense is a resin oil) are useful to inflammatory diseases such as Crohn’s disease."
  • "Preliminary studies conducted by medical research teams are also promising for shrinking tumors, particularly those in the brain.”
Herbal Calcium
On the page titled HORSETAIL Equisetum arvense – Grandmas Blog
  • “[H]orsetail is good for tumors…even good for cancer-like growths….” 
Immune Enhancer
On the page titled Immune Enhancer (Dietary Supplement)
  • "Best if used just prior to and during cold and flu season."
  • "This product is great for preventing colds and flu's that childres [sic] and teenagers contract associated with the beginning of the school year."
  • "Works well in conjunction with NATURE’S BIOTIC for colds and flu, and RESPIRATORY RELIEF during allergy season." 
InsideOut 10 ML
On the page titled InsideOut 10 ML (Essential Oil)
  • "InsideOut should be used for any bout of intestinal flu or food poisoning."
  • "This blend should be applied over the abdomen for colon problems and for candida overgrowth."
Kidney Cleansing and Strengthening
On the page titled Kidney Cleansing and Strengthening (Dietary Supplement)
  • "Helps to avoid issues such as kidney stones and kidney or urinary tract infections."
On the page titled HYDRANGEA Hydrangea arborescens – Grandmas Blog
  • “It is also used for cystitis, enlarged prostate, backache, gout, scurvy, dropsy and many other problems that relate the urinary system and stones. This is why hydrangea is used in Grandma’s herbal Kidney and Arth-Aid formulas."
Lavender 10 ml
On the page titled Lavender 10 ml (Essential Oil)
  • “It can bring relief from . . . headaches and migraines . . .”
  • “Lavender can be used for nearly all skin conditions. It can be applied to cuts, sunburns, burns, rashes, dermatitis, eczema, and insect bites. Consistent use of lavender with burns and injuries minimizes scarring. Lavender, usually as part of a blend, is often used to prevent or remedy conditions of dandruff and hair loss. Lavender is antiseptic, anti-inflammatory, cytophylactic, and antispasmodic, making it effective for muscle strains and sprains, cramps, and wound healing.”
Lemon 10 ml
On the page titled Lemon 10 ml (Essential Oil)
  • "Lemon essential oil supports the respiratory system and is useful for asthma, bronchitis, sore throat, sinusitis, and most other respiratory complaints "
  • "Lemon is very helpful in passing gallstones and is said to induce labor when the baby is overdue."
Lemongrass 10 ml
On the page titled Lemongrass 10 ml (Essential Oil)
  • "It is useful in bladder and kidney disorders and for healing varicose veins."
Millenia 10 ml
On the page titled Millenia 10 ml (Essential Oil)
  • "Millenia essential oil is effective in working with ADHD and hyperactivity." 
MyGraine 10 ml
On the page titled MyGraine 10 ml (Essential Oil)
  • "Often the aroma will be all that is needed to back off a migraine."
  • "MyGraine may be useful for some types of depression." 
Nature’s Biotic
On the page titled Nature’s Biotic (Dietary Supplement)
  • "[H]as been effectively used against fighting minor infections of all kinds.”
  • "Garlic assists in addressing minor cold and flu issues."
  • "[W]ell known ingredients that help to fight infection."
On the page titled Nature’s Biotic – Testimonials
  • “I definitely know these products improve your body to ward off infection.”
Nervine
On the page titled Nervine (Dietary Supplement)
  • "In this day and age, we seem to encounter a lot of stress…some signs and symptoms of an unhealthy or failing nervous system are: [...] physical symptoms like hives, rashes, shingles; insomnia... "
  • "I get shingles when I am under a tremendous amount of stress, which lately seems often. My doctor gave me all sorts of suggestions, one of them pain medication because they are extremely painful. I didn’t want to resort to pain medication. I found Grandma’s Herbs NERVINE, what a difference it made. It makes it so I can mentally and physically calm myself and slowly heal. I truly was amazed, and it confirmed my belief in natural remedies.”
On the page titled Mistletoe Viscum album – Grandmas Blog
  • “Mistletoe is used in Grandma’s herbal Nervine formula…In centuries past, mistletoe was used for cholera.” 
Paine
On the page titled Paine (Essential Oil)
  • "Paine is anti-inflammatory, antispasmodic… This essential oil blend can be used for sciatica, bone pain, arthritis, sports injuries, muscle spasms, torn ligaments, headaches, osteoporosis, bone spurs, bursitis, back pain, and bruising."
Pancreas-Aid
On the page titled Pancreas-Aid (Dietary Supplement)
  • "My diabetic sister said that my daughter had low blood sugar and suggested that she take some Grandma’s herbal PANCREAS AID as it would strengthen her pancreas and keep her from getting diabetes. ""
Prostate
On the page titled Prostate (Dietary Supplement)
  • "An enlarged prostate may cause a bladder infection or kidney damage. Many of these problems can be overcome with the use of Grandma's all natural PROSTATE and NATURE'S BIOTIC formulas taken together."
  • “I knew prostate problems happened to older men, but I was only 34 years old. I thought I was in pretty good shape until I started having pain and trouble urinating. Someone said it was because I didn’t drink enough water, so I drank more water. That helped but my prostate still bothered me and my back hurt. A friend suggested Grandma’s herbal PROSTATE formula. I took two capsules morning and evening an hour before meals. I also drank more water. Right away, like just two days later, I noticed a difference, but the pain didn’t leave altogether. The man at the health food store said if the pain was still there it could be an infection and that I should use some Grandma’s NATURE’S BIOTIC along with the PROSTATE formula. The day after I started using the NATURE’S BIOTIC with the PROSTATE, it didn’t hurt to urinate and my back ache was gone” 
Slim Too
On the page titled Slim Too (Caffeine Free) (Dietary Supplement)
  • "People take Garcinia by mouth [...] for treating worms and parasites"
SpiceC 10 ml
On the page titled SpiceC 10 ml (Essential Oil)
  • "Should be used for respiratory illnesses, colds, sore throats, bronchitis, flu . . ." 
Super Lax
On the page titled Rhubarb Rheum – Grandmas Blog
  • “In China, rhubarb tea and rhubarb juice is used to treat some forms of cancer. They also use it for tumors. It also helps to relieve the itchiness and pain of psoriasis, arthritis, eczema, herpes and some forms of hepatitis.” 
On the page titled Survived colon cancer
  • I consider myself a very lucky person to have survived colon cancer…I thought I would never again be “normal”…Since using Super-Lax…”
Tea Tree 10 ml
On the page titled Tea Tree 10 ml (Essential Oil)
  • "Tea tree essential oil is effective against some of the nastiest microbes on the planet. Tea tree can prevent sepsis in wounds and it (or something else effective) should be used to treat wounds, boils, sores, cuts, insect bites, and stings."
  • "Tea tree is also a mild tissue regenerator, making it a sensible choice for rashes, nail or skin fungal infections, wounds, cold sores, acne, athlete’s foot, ringworm, head lice, vaginal thrush (dilute very well here), and candida."
Vitality 10 ml
On the page titled Vitality 10 ml (Essential Oil)
  • "The anti-inflammatory properties of Vitality make it useful for arthritis, pleurisy, and sciatica.""
  • "[U]seful in treating toxemia during pregnancy if it is related to heart or circulation problems."
  • "Vitality reduces the size and painfulness of hemorrhoids. "
  • "It should be tried for all heart related and circulatory conditions, but Vitality has amazing uses in so many other areas. It is often useful for lowering high blood pressure . . ."
  • "Vitality is a remedy for the treatment of shock and has been used to stop or slow the progress of an oncoming stroke. For an impending stroke, Vitality should be quickly applied to the neck and forehead."
Warm Down 10 ml
On the page titled Warm Down 10 ml (Essential Oil)
  • "This blend is often reached for with sports injuries muscle strains and sprains, and for torn ligaments."
Your products Anti-Plague Formula, Bright Eyes, Cayenne, Deeper, Deliverance, Endo Relief, Eyebright Plus, EZ Traveler, Frankincense Certerii, Frankincense Serrata, Herbal Calcium, Immune Enhancer, InsideOut, Kidney Cleansing and Strengthening, Lavender, Lemon, Lemongrass, Millenia, MyGraine, Nature’s Biotic, Nervine, Paine, Pancreas-Aid, Prostate, Slim Too, SpiceC, Super Lax, Tea Tree, Vitality and Warm Down are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. 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), 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” means 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 products, Aspire, Cayenne, Endo Relief, Frankincense Certerii, Frankincense Serrata, Herbal Calcium, Kidney Cleansing and Strengthening, Lemon, Lemongrass, Millenia, MyGraine, Nervine, Prostate, SpiceC, Super Lax, and Vitality, 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. Furthermore, your Kidney Cleansing and Strengthening, Pancreas-Aid, and Vitality products are intended for prevention of one or more diseases that are not amenable to prevention by consumers themselves 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 Aspire, Cayenne, Endo Relief, Frankincense Certerii, Frankincense Serrata, Herbal Calcium, Kidney Cleansing and Strengthening, Lemon, Lemongrass, Millenia, MyGraine, Nervine, Pancreas-Aid, Prostate, SpiceC, Super Lax, and Vitality products 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)].
 
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. 
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations noted above. Your response should 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 all corrective actions within fifteen working days, state the reason for the delay and the date by which you will complete the correction.
 
Your written response should be sent to Nancy G. Schmidt, Compliance Officer, U.S. Food and Drug Administration, 6th Ave & Kipling St, Bldg 20-DFC, P.O. Box 25087, Denver, Colorado, 80225-0087. If you have any questions about this letter, please contact Ms. Schmidt by phone at (303) 236-3046 or by email at nancy.schmidt@fda.hhs.gov.
 
 
Sincerely,
/S/ 
LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Foods –
Division IV West
 
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