Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm403255.htm
Timestamp: 2019-04-20 11:27:51+00:00

Document:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.zarbees.com in May 2014 and has determined that you take orders there for the products “Zarbee’s Naturals Children’s Cough Syrup+Mucus Relief,” “Zarbee’s Naturals Children’s Cough Syrup,” “Zarbee’s Naturals Children’s Cough Syrup Nighttime,” “Zarbee’s Naturals Seasonal Relief,” “Zarbee’s Naturals Sleep,” and “Zarbee’s Naturals Children’s Sleep,”which the website promotes for conditions that cause the products to be 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)]. The therapeutic claims on your website establish that the products are drugs 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.
On February 6, 2014: "Dark honey[an ingredient used in “Zarbee’s Naturals Children’s Cough Syrup+Mucus Relief” and “Zarbee’s Naturals Children’s Cough Syrup”]…is clinically proven to calm coughs and sore throats in children…”.
On February 4, 2014: Zarbees commented “Mary, Thank you for writing this!!! We love to hear that we have helped people...” on this claim.
On January 7, 2014: Zarbees commented “Vivian, we switched that item out with our Children’s Nighttime Cough Syrup which works great!!!” on this claim.
Your products 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 the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your products “Zarbee’s Naturals Children’s Cough Syrup+Mucus Relief,” “Zarbee’s Naturals Children’s Cough Syrup Nighttime,” and “Zarbee’s Naturals Children’s Sleep” 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, these drugs 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)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. 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 legal action without further notice, including seizure and/or injunction.
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing Denver District Office, 6th & Kipling Street, PO BOX 25087, Denver, CO 80225 (Attn: Bryan Love, Acting Compliance Officer). If you have any questions about the contents of this letter, please contact: Mr. Love at 303-236-3059 (phone) or 303-236-3551 (fax).

References: § 321
 § 321
 § 355
 § 331
 § 352
 § 331