WARNING LETTER
Hello Life, Inc MARCS-CMS 525301 —
- Delivery Method:
- UPS
- Recipient:
-
Recipient NameAlbert R. Duoibes
- Hello Life, Inc
4635 40th St. SE
Kentwood, MI 49512
United States
- Issuing Office:
- Chicago District Office
United States
Chicago District Office | |
WARNING LETTER
FY17-HAFE6-04
August 7, 2017
UPS NEXT DAY
SIGNATURE REQUIRED
Albert R. Duoibes, CEO/President
Hello Life, Inc.
4635 40th St. SE
Kentwood, MI 49512
Dear Mr. Duoibes:
From March 7-10, 2017, an investigator with the U.S. Food and Drug Administration (FDA) inspected your facility located at 4635 40th St. SE, Kentwood, Michigan. During this inspection, the FDA collected labels and a sample of your “Diamaxol” dietary supplement product. Our review of your product labels and sample analysis reveal that your “Diamaxol” dietary supplement product is misbranded within the meaning of section 403(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)]. The introduction or delivery for introduction into interstate commerce, or causing thereof, of such misbranded product is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)]. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Our sampling analysis of your “Diamaxol” dietary supplement product revealed magnesium levels at 77.5mg/serving (62% of declared), manganese at 0.255mg/serving (25.5% of declared), and zinc 3.86mg/serving (51.5% of declared). Magnesium, manganese, and zinc are class I vitamins as defined in 21 CFR 101.9(g)(3). Under 21 CFR 101.9(g)(4)(i), a food (including a dietary supplement) with a label declaration of a class I nutrient shall be deemed to be misbranded under section 403(a) of the Act unless the nutrient content of the composite is at least equal to the value for that nutrient declared on the label. Because your “Diamaxol” dietary supplement product does not contain levels of magnesium, manganese, and zinc at least equal to the value declared on the label, as required by 21 CFR 101.9(g)(4)(i), the product is deemed to be misbranded under section 403(a) of the Act.
The above violation is not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. It is your responsibility to ensure that all the products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations.
You should take prompt action to correct the violation cited in this letter. Failure to promptly correct these violations may result in regulatory action by FDA without further notice, including, without limitation, seizure and/or injunction. Please respond in writing within fifteen (15) working days of receipt of this letter describing the specific steps you have taken to correct the violations and to prevent these violations or other similar violations from occurring again. In your response, you should include any documentation necessary, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, you should explain the reason for your delay and include a timetable for implementation of the corrections.
Your written response should be directed to:
Dr. Byron Ho, Compliance Officer
U.S. Food and Drug Administration
300 River Place, Suite 5900
Detroit, MI 48207
If you have any questions regarding this letter, please contact Compliance Officer Dr. Byron Ho at byron.ho@fda.hhs.gov or 313-393-8262.
Sincerely,
/S/
William R. Weissinger, MS
Chicago District Director
Division of Human and Animal Food
Operations Division 6 East