CAERS_FACTS_Data_Screen_Redacted.pdf

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Change in mood quality or level;

anxiety Sleep problems

NERVOUS

NERVOUS

07/13/2016 TelephoneCHI-DO DET-DO Friend/Relative of Consumer

Complainant reports that her 19 year old son illegally purchased Blackstone Labs Dust Extreme from in

IL. She reports that the product contains DMAA, an additive that has been banned by the FDA. She also reports that in the store the sign states that the product should not be sold to anyone under 21. Since her son has been using the product she reports that his attitude has changed. He is quick to anger and he has had problems sleeping. Complainant's son was able to take the product back to the store for a refund. She contacted the manufacturer on 7/12/16 and they informed her that this is a new product and that DMAA is not illegal.

Non-Life Threatening Injury/Illness - No Adverse Event Reporting

6/26/16

Immediate

Immediate quick to anger

Pending at Branch

Other - identify in Remarks

Notify

DEIO/EMOPS?

Notification Date

Attended Health Professional?

Required Hospitalization?

Reported Complaint To?

Emergency Room / Outpatient Visit?

Need addnl.

FDA Contact?

Complaint/Injury

Complaint Description Adverse Event Date

Adverse Event Result

Injury / Illness

Phone (W) Phone (H) Source POC Name Source Phone

Complainant Identification

Name Address

United States Food and Drug Administration Consumer Complaint / Injury Report

Complaint Date

COMPLAINT

Receiving Organization

Accomplishing District

How Received

Complaint Source

Complaint Status

Health Care Professional

Provider Name Address Occupation

Hospital Information

Hospital Name Address Dates of Stay

Yes 07/14/2016 No No Reported to Manufacture r

No Yes

Symptom System Affected Onset Time Duration Remarks

Remarks Quick to anger, trouble sleeping

Complaint Symptoms

This is an accurate reproduction of the original electronic record as of 07/14/2016

Complaint Received By

Phone

Phone

(b) (6) (b) (6)

(b) (6)

(b) (6)

(b) (6)

Olivia.Kuntong Typewritten Text

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Complaint #

Product and Labeling

Brand Name

Blackstone Labs

Product Name

Dust Extreme - Sour Gummie Bear flavor

Product Code

54YCY99

Product Description

Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.;Hum Fd Dietary Suppl Multi Ingr;NEC

PAC

03R801

Qty / Unit / Package

12.69 Ounces Jug

Lot/ Serial # unk

Exp/Use by Date unk

Purchase Date

6/26/16

Product Used

Yes

Amount Consumed/Used unk

Date Used

6/26/16

Date Discontinued unk

Amount Remained none (returned)

Imported Product?

No

Country of Origin

United States

Label Remarks

Product PDP states 75mg of

DMAA

Problem Ingredient Group

Name Address

Retail

Manufacturer/Distributor

FEI Name & Address Home District Firm Type

ATL-DO

DET-DO

Ingredient Supplier

Manufacturer

Initial Evaluation/Initial Disposition

Problem Keyword Problem Keyword Details

Other, identify in Details Reaction product contains banned additive DMAA quick to anger, trouble sleeping

Initial Evaluation Initial Disposition Disposition Made By Disposition Date

FDA Action Indicated Referred to Other FDA District 07/14/2016Hudson,Christinae R

Initial Disposition Remarks

Complainant reports that Blackstone Labs informed her that they purchase the DMAA from Hi Tech Pharmaceuticals. Upon a quick research it appears that FDA is in a legal battle with several companies including Hi Tech regarding the use of DMAA.

According to fda.gov article dated 7/2013, DMAA is an illegal additive.

UPC Code

Emergency Room/Outpatient Visit

Hospital Name Address Phone ER Date unk

(b) (4)

(b) (6) (b) (6)

(b) (6)

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Complaint #

Org Name

DET-DO

HHS Mail Code

HFR-MW200

Referrals

There are no Adverse Event details for this Complaint.

There are no Cosmetics details for this Complaint.

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Grouped Follow - Up Operations

COMPLAINTS FOLLOW - UP

Operation Id

Operation Code

Assignment Number

Accomplishing Organization

Performing Organization

Sample Number

PAF Status Status Date

Disposition Summary

Responsible

FEI

Firm TypeNameIs Consumer Responsible?

Address

Follow-Up Disposition Disposition Made By Disposition Date

Follow-Up Sent To

Organization Name HHS Mail Code

There are no Follow Up Operations related to this complaint.

Disposition Remarks

Complaint