Atlanta District Office
60 8th Street NE
Atlanta, GA 30309 

 

April 17, 2017
 
VIA OVERNIGHT DELIVERY
and CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
Iris Sylvia
Everything Herbs
P.O. Box 581
Montmorenci, SC 29839
 
WARNING LETTER  
(17-ATL-07)
 
Dear Ms. Sylvia,        
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.everythingherbs.com, from which you take orders for the following products: Art.-C, Black Walnut, Cleavers, Inkberry, Korean Ginseng, Lapacho, Red Clover, and Whole Apricot. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.  
 
Based on the labeling claims on your website, your products are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of such disease claims found in the labeling of these products include, but may not be limited to, the following:
 
Art.-C
Black Walnut
Cleavers
Inkberry
Korean Ginseng
Lapacho
Red Clover
Whole Apricot
Your 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)]. 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. 
 
Furthermore, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under 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. 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 you comply 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 (15) 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. 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 fifteen (15) 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, Lakisha N. Morton, Compliance Officer, Food and Drug Administration, 60 8th Street NE; Atlanta, GA 30309. If you have any questions with regard to this letter, please contact Mrs. Morton at 404-253-1285 or email Lakisha.Morton@fda.hhs.gov.
 
Sincerely,
/S/ 
Ingrid A. Zambrana
District Director
Atlanta District Office
Southeast Region, Office of Regulatory Affairs
U. S. Food and Drug Administration

This page was posted on April 30, 2019.

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