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Public Health Service
Food and Drug Administration
  

 

February 4, 2016
 
WARNING LETTER
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
Jeff Gallagher
Michigan Herbal Remedies, LLC (aka MHR LLC)
d/b/a Tasty Hemp Oil
d/b/a US Hemp Wholesale
d/b/a Alternate Vape
6411 Bella Vista Drive
Suite 1
Rockford, MI 49341
 
Dear Jeff Gallagher:                                                                                       
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the internet addresses www.michiganherbalremedies.com, www.tastyhempoil.com, www.ushempwholesale.com, and www.alternatevape.com in January 2016, and has determined that you take orders there for the products “Bluebird Botanicals Bulletproof CBD Blend,” “US Hemp Wholesale 25% CBD Hemp Oil Supplement” (aka “Gold Label CBD Hemp Oil”), “Plus CBD Oil,” “Endoca Hemp Oil,” “Tasty Hemp Oil Tasty Drops,” “Tasty Vape Just Peachy” and “Alternate Vape Luv-A-Bull,” which you claim to contain cannabidiol (CBD).  FDA also reviewed your social media websites at https://twitter.com/michiganherbal, https://twitter.com/tastyhempoil, https://twitter.com/ushempwholesale, https://twitter.com/alternatevape, and https://www.pinterest.com/MichiganHerbal/. The claims on your websites 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 diagnosis, 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.  
 
Although you market “Bluebird Botanicals Bulletproof CBD Blend,” “US Hemp Wholesale 25% CBD Hemp Oil Supplement” (aka “Gold Label CBD Hemp Oil”), “Plus CBD Oil,” “Endoca Hemp Oil,” and “Tasty Hemp Oil Tasty Drops” as dietary supplements, FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)].  Under that provision, if an article (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.
 
The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex[1]. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR § 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the Act. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act, but you may present FDA with any evidence that has bearing on this issue.
 
Examples of claims observed on your websites that establish the intended use of your products include, but may not be limited to, the following:
 
On the website www.michiganherbalremedies.com:
On the website www.tastyhempoil.com:
On the website www.ushempwholesale.com:
On the website www.alternatevape.com:
Examples of claims observed on your social media accounts that establish the intended use of your products include, but may not be limited to, the following:
 
https://twitter.com/michiganherbal
https://twitter.com/tastyhempoil
https://twitter.com/ushempwholesale
https://twitter.com/alternatevape
https://www.pinterest.com/MichiganHerbal/
Your products “Bluebird Botanicals Bulletproof CBD Blend,” “US Hemp Wholesale 25% CBD Hemp Oil Supplement” (aka “Gold Label CBD Hemp Oil”), “Plus CBD Oil,” “Endoca Hemp Oil,” “Tasty Hemp Oil Tasty Drops,” “Tasty Vape Just Peachy” and “Alternate Vape Luv-A-Bull” 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)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the 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 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 “Bluebird Botanicals Bulletproof CBD Blend,” “US Hemp Wholesale 25% CBD Hemp Oil Supplement” (aka “Gold Label CBD Hemp Oil”), “Plus CBD Oil,” “Endoca Hemp Oil,” “Tasty Hemp Oil Tasty Drops,” “Tasty Vape Just Peachy” and “Alternate Vape Luv-A-Bull” 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, “Bluebird Botanicals Bulletproof CBD Blend,” “US Hemp Wholesale 25% CBD Hemp Oil Supplement” (aka “Gold Label CBD Hemp Oil”), “Plus CBD Oil,” “Endoca Hemp Oil,” “Tasty Hemp Oil Tasty Drops,” “Tasty Vape Just Peachy” and “Alternate Vape Luv-A-Bull” fail to bear adequate directions for their intended uses 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 intended to be an all-inclusive statement of violations that exist in connection with your products and their labeling. 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 assure that your firm complies with all requirements of federal law and FDA regulations. 
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and 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 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to:
 
U.S. Food and Drug Administration                                                             
CDER/OC/OUDLC
10903 New Hampshire Avenue, WO51
Silver Spring, MD 20993-0002
FDAADVISORY@fda.hhs.gov  
 
Sincerely,
/S/
Ilisa Bernstein, Pharm.D., J.D.
Deputy Director
Office of Compliance
Center for Drug Evaluation and Research


[1] See “Sativex Commences US Phase II/III Clinical Trial in Cancer Pain,” available at http://www.gwpharm.co.uk/Commences%20US%20Phase%20IIIII%20Clinical%20Trial.aspx and “GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome,” available at http://www.gwpharm.com/GW%20Pharmaceuticals%20Receives%20Investigational%20New%20Drug%20IND%20from%20FDA%20for%20Phase%2023%20Clinical%20Trial%20of%20Epidiolex%20in%20the%20Treatment%20of%20Dravet%20Syndrome.aspx.

This page was posted on March 28, 2019.

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