FDA Safety Alerts, Recalls and Warnings

REFA Enterprises, LLC Issues Voluntary Nationwide Recall of Forever Beautiful Bee Pollen Due to Undeclared Sibutramine and Phenolphthalein

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. 

Public Notification: Slim-Vie contains hidden drug ingredient

[11-25-2014] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Slim Vie, a product promoted and sold for weight loss on various websites, and possibly in some retail stores.

FDA laboratory analysis confirmed that Slim-Vie containssibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
 
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories. 

2014 Warning Letters - Health Fraud

Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* - related violations.

For all FDA Warning Letters, click here.

Letter Issue Date	Company Name	Issuing Office	Subject
12/23/2014	Shoreside Enterprises Inc.	Florida District Office	Unapproved New Drugs/Misbranded
12/17/2014	Dandy Day Corporation	Denver District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
11/24/2014	Cell Vitals	Center for Food Safety and Applied Nutrition	New Drug/Labeling/Misbranded
11/24/2014	Jansen Enterprises, LLC dba HealthWorksUSA	Minneapolis District Office	New Drug/Labeling/Misbranded
11/19/2014	LifeSilver	Center for Food Safety and Applied Nutrition	Unapproved New Drugs/Misbranded
11/21/2014	Fioravanti Custom Products DBA Essential Wholesale & Labs	Seattle District Office	New Drugs/Cosmetics Labeling and Marketing with Drug Claims
11/18/2014	Bodyhealth.com, LLC	Center for Food Safety and Applied Nutrition	Unapproved New Drugs/Misbranded
11/18/2014	Ebola-C Inc	Center for Food Safety and Applied Nutrition	Unapproved New Drugs/Misbranded
11/14/2014	Scientific Botanicals Company, Inc.	Seattle District Office	CGMP/Dietary Supplement/Adulterated/Misbranded/Therapeutic Claims
11/03/2014	Avena Botanicals, Inc.	New England District Office	CGMP/Dietary Supplement/Adulterated/Misbranded
10/30/2014	PI Pharma Inc	Cincinnati District Office	Unapproved New Drugs/Misbranded
10/17/2014	Golden Pride, Inc.	Florida District Office	Unapproved New Drugs/Misbranded
10/17/2014	Vitamins Direct (USA), Inc.	Florida District Office	Unapproved New Drugs/Misbranded
10/16/2014	Alopecil Corporation, S.R.L.	Center for Food Safety and Applied Nutrition	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
10/16/2014	Vitalab Co Inc	Kansas City District Office	CGMP/Unapproved New Drugs/Dietary Supplements/Adulterated/Misbranding/Labeling
10/15/2014	Citrus Fit	Dallas District Office	Unapproved New Drugs/Misbranded
10/15/2014	Health & Herbs	Seattle District Office	CGMP/Dietary Supplement/Adulterated/Therapeutic Claims
10/09/2014	Health Research Laboratories LLC	Dallas District Office	New Drug/Misbranded
10/09/2014	Bethel Nutritional Consulting, Inc	New York District Office	New Drug/Misbranded
10/07/2014	Windmill Health Products, LLC	New Jersey District Office	CGMP/Dietary Supplement/Adulterated/Misbranded
10/07/2014	YoungYou International Inc	Los Angeles District Office	Unapproved New Drugs/Misbranded
09/26/2014	Nova Products, Inc.	Philadelphia District Office	Unapproved New Drugs/Misbranded
09/25/2014	Multimmunity, Inc.	Denver District Office	New Drug/Labeling/Misbranded
09/24/2014	Calcomp Nutrition Llc	Philadelphia District Office	Unapproved New Drugs/Misbranded
09/23/2014	Natural Solutions Foundation	New Jersey District Office	Unapproved New Drugs/Misbranded
09/22/2014	dōTERRA International, LLC	Denver District Office	Unapproved New Drugs/Misbranded
09/22/2014	Young Living	Denver District Office	Unapproved New Drugs/Misbranded
09/15/2014	West Coast Laboratories Inc	Los Angeles District Office	Unapproved New Drugs/Misbranded
08/28/2014	CreAgri, Inc.	San Francisco District Office	New Drug/Labeling/False & Misleading Claims
08/26/2014	GE PHARMA LLC	New England District Office	CGMP/Dietary Supplement/Adulterated/Misbranded
08/19/2014	Descor LLC	Baltimore District Office	Unapproved New Drugs/Misbranded
08/18/2014	HUMAN SCIENCE FOUNDATION	Los Angeles District Office	Unapproved Drugs/Misbranded
07/30/2014	Plexus Worldwide Inc	Los Angeles District Office	New Drug/Misbranded
07/25/2014	AMS Health Sciences	Dallas District Office	Unapproved New Drugs/Misbranded
07/25/2014	Mezotrace Corporation	San Francisco District Office	CGMP/Dietary Supplement/Adulterated
07/24/2014	Healthtime dba Deer Garden Foods	San Francisco District Office	New Drug/Labeling/Misbranded
07/17/2014	Schindele Enterprises dba Midwest Wholesale	Kansas City District Office	Unapproved/Misbranded drugs
07/17/2014	Klein Laboratories, Inc.	New England District Office	Unapproved New Drug/Adulterated
07/14/2014	Noni Connection dba Puna Noni	San Francisco District Office	CGMP/Dietary Supplement/Adulterated/Misbranded
07/10/2014	Black International Enterprise, LLC dba Puba Store	Florida District Office	Unapproved New Drugs/Misbranded
07/08/2014	Dr Benedict S Liao Md	Los Angeles District Office	New Drug/Labeling/False & Misleading Claims
07/08/2014	Atlantic Trading Co. LLC	Center for Food Safety and Applied Nutrition	Unapproved New Drugs/Misbranded
07/08/2014	Dr. Bronner's Magic Soaps	Center for Food Safety and Applied Nutrition	Unapproved New Drugs/Misbranded
07/03/2014	Solace International, Inc.	San Francisco District Office	Unapproved New Drug/Misbranded
06/30/2014	Ramon Rosa	San Juan District Office	Unapproved New Drug/Misbranded
06/27/2014	Zarbee's, Inc.	Denver District Office	New Drug/Labeling/Misbranded
06/24/2014	Albert Max Inc. dba: Vita Springs Health	Los Angeles District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
06/05/2014	Nutrishop	New Jersey District Office	Unapproved New Drug/Misbranded
04/23/2014	Ip-6 International Inc	Florida District Office	Unapproved and Misbranded New Drugs
04/22/2014	Mundo Natural Inc	San Juan District Office	Unapproved and Misbranded New Drugs
04/22/2014	River Hills Harvest dba Elderberrylife	Kansas City District Office	Labeling/False & Misleading/New Drug/Misbranded
04/18/2014	Iowa Select Herbs	Kansas City District Office	New Drug/Labeling/Misbranded/CGMP/Adulterated
04/17/2014	CDJ Holding, Inc., DBA Pacific BioLogic Co.	San Francisco District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
04/04/2014	Xtra Life Natural Systems, Inc.	Florida District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
04/04/2014	Driven Sports Inc.	Center for Food Safety and Applied Nutrition	Dietary Supplement/Adulterated
04/02/2014	Graviola Group	San Juan District Office	Unapproved and Misbranded New Drugs
04/01/2014	Bio-Recovery Inc.	Minneapolis District Office	CGMP/Dietary Supplement/Adulterated/Misbranded
03/28/2014	M&A Caribbean Traders, Inc	San Juan District Office	Unapproved and Misbranded New Drugs
03/21/2014	Aloe Man International Corp	Florida District Office	CGMP/Dietary Supplement/Adulterated/Misbranded
03/07/2014	Deseo Rebajar	San Juan District Office	Unapproved and Misbranded New Drugs
01/31/2014	Exclusive Supplements, Inc.	Philadelphia District Office	Unapproved and Misbranded New Drugs
01/31/2014	NatureAll-STF Holding, LLC	Denver District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
01/31/2014	Slim Beauty USA	Kansas City District Office	Unapproved New/Misbranded drugs
01/30/2014	Amber Technology, LLC	Denver District Office	New Animal Drug/Adulterated
01/23/2014	Pacific Standard Distributors, Inc	Seattle District Office	Internet Marketing of Unapproved and Misbranded Drugs
01/22/2014	Intensive Nutrition Incorporated	San Francisco District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated

*The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.

source: http://www.fda.gov/forconsumers/protectyourself/healthfraud/ucm431941.htm