Inspections, Compliance, Enforcement, and Criminal Investigations

Amafruits 7/21/17

 

  

Black HHS-Blue FDA Logo

 

Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187 

 
 

 

WARNING LETTER
FY17-HAFE6-03
 
 
July 21, 2017
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
Brandon Michael Hovey
Amafruits LLC
16249 107th Avenue
Suite 6
Orland Park, IL 60467
 
5 Old Tamarck Ln
Orland Park, IL 60462
 
 
Dear Mr. Hovey,        
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your company website at www.amafruits.com in May 2017. You take orders on this website for the following products: Acai Fruit Puree, Acerola Fruit Puree, Cupuacu Fruit Puree, Goiaba Fruit Puree, and Graviola Fruit Puree. FDA also reviewed your Facebook page, https://www.facebook.com/amafruits/, and you Twitter page, www.twitter.com/amafruits, which contain links to your website at www.amafruits.com.The claims on your company website, Facebook page, and Twitter page 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 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 labeling claims that provide evidence that these products are intended for use as drugs on your website include, but may not be limited to, the following:
 
On the Açaí webpage, www.amafruits.com/acai:
  • “Anthocyanins … protecting against some chronic diseases, including cancer, cardio- and cerebro-vascular, atherosclerosis and diabetes … potential radiation-protective, chemo-protective, vaso-protective and anti-inflammatory effects.”
  • “[L]inked with lower heart disease … and lower risk of some cancers”
  • “[R]educing blood cholesterol”
On the Acerola webpage, www.amafruits.com/acerola:
  • “Traditionally, acerola has been consumed in Brazil as a natural remedy for fever and dystentery, as well as being used as an anti-inflammatory, astringent, diuretic, arterial stimulant for the liver and renal systems.”
  • “[N]atural aid for anaemia, diabetes, high cholesterol … fungal infections, rheumatism and tubercolosis [sic]”
  • “Acerola is also used for preventing heart disease, ‘hardening of the arteries’ (atherosclerosis), blood clots, and cancer.”
  • “[T]reat the common cold, pressure sores, bleeding in the eye (retinal hemorrhages), tooth decay, gum infections, depression, hay fever …”
On the Cupuaçu webpage, www.amafruits.com/cupuacu:
  • “Cupuaçu benefits … lowering of blood pressure … lowered cholesterol levels”
  • “Other common traditional uses for cupuaçu include: … For combating diabetes”
On the Goiaba webpage, www.amafruits.com/goiaba:
  • “[C]onsumption of fruits rich in vitamin-C helps the human body develop resistance against infectious agents”
  • “[L]ycopene … prevents skin damage from UV rays and may offer protection from prostate issues”
  • “Potassium … helps controlling heart rate and blood pressure.”
In addition, claims made on your Facebook page at https://www.facebook.com/amafruits/, which provides a link to your website at www.amafruits.com, provide additional evidence that your products are intended for use as drugs: 
 
Posts by your company on your Facebook timeline page include the following:
  • On April 13, 2017: “#goiaba … protect the colon by reducing the risk of cancer-causing toxins”
  • On March 11, 2017: “Acai every day may improve blood sugar, insulin … risk factors for diabetes and cardiovascular disease.”
  • On February 26, 2017: “Goiaba can offer protection against born pathogens”
  • On February 7, 2017: “Graviola … anti-tumor treatment.”
  • On December 2, 2016: “[G]raviola has anti-inflammatory properties that help reduce blood pressure … and can kill over 12 types of cancer!” 
Photo posts by your company on your Facebook page include the following:
  • On April 26, 2017: “ACAI BERRIES … FIGHTS AGAINST CANCER”
  • On October 25, 2013: “ANTIOXIDANTS IN Açaí BERRY … reduce the chance of developing many types of cancer … They protect your body against chronic disease such as cardio-and-cerebrovascular, atherosclerosis and diabetes.”
Furthermore, claims on your Twitter page, www.twitter.com/amafruits, which has a link to your website at www.amafruits.com, provide further evidence that your products are intended for use as drugs:
  • On December 2, 2016: “Graviola has anti-inflammatory properties that help reduce blood pressure … fruit that can beat cancer.” 
We also note that FDA collected a document titled “amafruits, SUPERFRUITS FROM THE AMAZON, Açaí BERRY” at the 2017 Natural Products Expo West trade show that was held on March 8 – 12, at the Anaheim Convention Center. This document refers readers to your website at www.amafruits.com. Claims included in this document that provide evidence that your products are intended for use as drugs:
  • “Benefits of Açaí Berry … reduce risk factors for cancer”
Your Acai Fruit Puree, Acerola Fruit Puree, Cupuacu Fruit Puree, Goiaba Fruit Puree, and Graviola Fruit Puree products are not generally recognized as safe and effective for the above referenced uses and, therefore, the Acai Fruit Puree, Acerola Fruit Puree, Cupuacu Fruit Puree, Goiaba Fruit Puree, and Graviola Fruit Puree 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 submitted by a drug sponsor to demonstrate 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 Acai Fruit Puree, Acerola Fruit Puree, Cupuacu Fruit Puree, Goiaba Fruit Puree, and Graviola Fruit Puree products 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, your Acai Fruit Puree, Acerola Fruit Puree, Cupuacu Fruit Puree, Goiaba Fruit Puree, and Graviola Fruit Puree products fail to bear adequate directions for their intended use and, therefore, the Acai Fruit Puree, Acerola Fruit Puree, Cupuacu Fruit Puree, Goiaba Fruit Puree, and Graviola Fruit Puree 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 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 (15) working days of receipt of this letter, please notify this office in writing of 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 corrective action within fifteen working days, please explain the reason for the delay and the date by which you will make the correction.
 
Your response should be sent to U.S. Food and Drug Administration, Lauren Crivellone, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., Suite 1500, Chicago, IL 60661. If you have any questions with regard to this letter, please contact Lauren Crivellone at (312) 596-4157 ext. 4157 or email lauren.crivellone@fda.hhs.gov.
 
Sincerely,
/S/ 
Kelli Wilkinson
 

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