U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Chaotic Labz - 491536 - 03/31/2016
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Chaotic Labz MARCS-CMS 491536 — Mar 31, 2016

Chaotic Labz - 491536 - 03/31/2016


Recipient:
Recipient Name
Chaotic Labz
Chaotic Labz

220 Hankins Drive

Atkins, AR 72823
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740 

 

WARNING LETTER
MAR 31 2016 
 
VIA OVERNIGHT DELIVERY, RETURN RECEIPT REQUESTED
VIA EMAIL
 
Cordy Hooten
Chaotic Labz
220 Hankins Drive
Atkins, AR 72823
 
                                                            Re: 491536
 
Dear Mr. Hooten:
 
This letter concerns your product Malice which is labeled and/or offered for sale as a dietary supplement. The ingredient list on your product labeling declares methylsynephrine as a dietary ingredient. This ingredient is also called, among other names, Oxilofrine and p-hydroxyephedrine (hereinafter referred to as methylsynephrine).
 
Under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)], a dietary ingredient is a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Methylsynephrine is not a vitamin, a mineral, an herb or other botanical, or an amino acid. In addition, according to our research, methylsynephrine is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Finally, methylsynephrine is not a concentrate, metabolite, constituent, extract, or combination of a vitamin; mineral; herb or other botanical; amino acid; or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Accordingly, methylsynephrine is not a dietary ingredient within the definition set forth in section 201(ff)(1) of the Act. Declaring methylsynephrine in your product labeling as a dietary ingredient causes your products marketed as dietary supplements to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular.
 
We request that you take prompt action to correct the violation cited above, as well as any other violations associated with your Malice product or other products marketed by your firm that list methylsynephrine as a dietary ingredient in the labeling. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
Failure to immediately cease distribution of your Malice product, and any other products you market that list methylsynephrine as a dietary ingredient in the labeling could result in enforcement action by FDA without further notice. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334]. 
 
Additionally, methylsynephrine is not approved as a food additive or prior sanctioned for use in dietary supplements. Further, FDA's review of this substance does not identify a basis to conclude that the substance is GRAS for use in food. If you contend that this substance is GRAS for use in food, please provide your basis for concluding that methylsynephrine is GRAS for use in dietary supplements, including supporting data or other documentation.
 
We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of each step taken to ensure that similar violations do not recur, as well as documentation to support your response. Your written reply should be directed to Aaron Dotson, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Aaron Dotson at aaron.dotson@fda.hhs.gov.
 
Sincerely,                                                                      
 /s/ 
William A. Correll
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
 
 
cc:
 
9684 Market St.
Dover, Arkansas 72837