Mr. Bret Furio
- Zarbee's, Inc.
50 Old Field Point Rd
Greenwich, CT 06830
- Issuing Office:
- Denver District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Denver District Office|
Building 20-Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
VIA UPS Overnight
Mr. Bryce L. Johnson, Owner
11650 S State St., Ste. 101
Draper, UT 84020-7144
Dear Mr. Johnson:
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.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Zarbee’s Naturals Children’s Cough Syrup-Grape
Zarbee’s Naturals Seasonal Relief 10 Count
- “[C]linically supported to work fast and offer congestion relief so you can breathe better in every season.*”
- “Proven congestion relief*”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
Zarbee’s Naturals Sleep
- “I feel much safer taking these tablets, compared with prescription or OTC sleeping pills, because melatonin & L-theanine are natural substances.”
Zarbee’s Naturals Seasonal Relief 10 Count
- “I took one of the tablets, used eye wash, and within 30 minutes, the itching and redness was gone.”
- On February 7, 2014: “Try @Zarbees #naturalremedies for Cold and Cough Season…”
- On January 30, 2014: “RT@MomCentral Have you tried #ZarbeesCough for cold and cough relief?”
Posts by your company on your Facebook page include the following:
- On February 12, 2014: "Natural Ivy Leaf extract…helps thin and loosen wet mucus coughs…[u]sed in our Children’s Cough Syrup +Mucus Relief…”
- 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…”.
Your Facebook page also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials, which are endorsed or promoted by Zarbees, include:
- Zarbees “liked” the following comment made on February 11, 2014: “…Children’s Sleep remedy…I received the free sample…and…gave it to my daughter…I could not believe how well it worked! She was recently diagnosed with ADHD and put on medication…causing insomnia…”
- On February 4, 2014: “…I received your…Zarbee’s Naturals Children’s Sleep Product. I have a daughter…born with cerebral palsy and she suffers from Complex Regional Pain Syndrome… [s]he took the samples you sent and slept through the night…best sleep she has had in years…”
- On February 4, 2014: Zarbees commented “Mary, Thank you for writing this!!! We love to hear that we have helped people...” on this claim.
- Zarbees “liked” the following comment made on January 7, 2014: “I’ve been battling either bronchitis or pneumonia for the last 18 days and have tried everything…your Children’s Cough Syrup and mucus relief got rid of…my hoarsness [sic]…[m]y throat and chest are beginning to feel so much better…”
- On January 6, 2014: “…It is the best thing for my granddaughters bronchitis.”
- 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.
- Zarbees “liked” the following comment made on October 30, 2013: “Love Zarbee’s this is the only medicine we use for our 2 year old. Colds and congestion clear up in 2 days.”
- Zarbees “liked” the following comment made on October 15, 2013: “Received the sample for allergy relief and my husband had a terrible problem with allergies…he was very impressed on how well it worked for him…”
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.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above. Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete all corrections within 15 working days, please explain the reason for the delay and the date by which each such item will be corrected.
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).
LaTonya M. Mitchell
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