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
Aspire 10 ml
On the page titled Aspire 10 ml (Essential Oil)
Bright Eyes
On the page titled Bright Eyes (Dietary Supplement)
Cayenne
On the page titled Cayenne (Dietary Supplement)
On the page titled CAYENNE (Capsicum frutescens) – Grandmas Blog
On the page titled Cayenne – Testimonials
Deeper 10ml
On the page titled Deeper 10ml (Essential Oil)
Deliverance 10 ml
On the page titled Deliverance 10 ml (Essential Oil)
Endo Relief 10 ml
On the page titled Endo Relief 10 ml (Essential Oil)
Eyebright Plus
On the page titled Eyebright Plus (Dietary Supplement)
EZ Traveler 10 ml
On the page titled EZ Traveler 10 ml (Essential Oil)
Frankincense, Certerii 10ml
On the page titled Frankincense, Certerii 10ml (Essential Oil)
Frankincense, Serrata 10 ml
On the page titled Frankincense, Serrata 10 ml (Essential Oil)
Herbal Calcium
On the page titled HORSETAIL Equisetum arvense – Grandmas Blog
Immune Enhancer
On the page titled Immune Enhancer (Dietary Supplement)
InsideOut 10 ML
On the page titled InsideOut 10 ML (Essential Oil)
Kidney Cleansing and Strengthening
On the page titled Kidney Cleansing and Strengthening (Dietary Supplement)
On the page titled HYDRANGEA Hydrangea arborescens – Grandmas Blog
Lavender 10 ml
On the page titled Lavender 10 ml (Essential Oil)
Lemon 10 ml
On the page titled Lemon 10 ml (Essential Oil)
Lemongrass 10 ml
On the page titled Lemongrass 10 ml (Essential Oil)
Millenia 10 ml
On the page titled Millenia 10 ml (Essential Oil)
MyGraine 10 ml
On the page titled MyGraine 10 ml (Essential Oil)
Nature’s Biotic
On the page titled Nature’s Biotic (Dietary Supplement)
On the page titled Nature’s Biotic – Testimonials
Nervine
On the page titled Nervine (Dietary Supplement)
On the page titled Mistletoe Viscum album – Grandmas Blog
Paine
On the page titled Paine (Essential Oil)
Pancreas-Aid
On the page titled Pancreas-Aid (Dietary Supplement)
Prostate
On the page titled Prostate (Dietary Supplement)
Slim Too
On the page titled Slim Too (Caffeine Free) (Dietary Supplement)
SpiceC 10 ml
On the page titled SpiceC 10 ml (Essential Oil)
Super Lax
On the page titled Rhubarb Rheum – Grandmas Blog
On the page titled Survived colon cancer
Tea Tree 10 ml
On the page titled Tea Tree 10 ml (Essential Oil)
Vitality 10 ml
On the page titled Vitality 10 ml (Essential Oil)
Warm Down 10 ml
On the page titled Warm Down 10 ml (Essential Oil)
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
 

This page was posted on April 30, 2019.

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