Mama mia! FDA busts ABBA (Pharmaceuticals, that is)

The FDA has issued a warning letter to Florida-based dietary supplement manufacturer Abba Pharma because they are misrepresenting their products.


Although these pill makers are urging you to Take A Chance on Me, they’re now in trouble because, Mamma Mia!, they’re pumping out pills like a Super Trouper. 


But now they have to issue an S.O.S. because of the multiple safety violations listed by the FDA. What happens next? Well, Knowing Me, Knowing You, there is nothing we can do because there is Money, Money, Money at stake here. 


Bottom line? 
Kidding aside, Abba Pharma represents another reason why you should think very carefully about taking supplements at all because 1) the safety regulations are loose, and 2) their effectiveness is questionable anyway. 


If you to take supplements, something you should do is to check out who is producing them. Safety actually is a concern and you should be aware of this. 


Here are the violations: 

• Failure to test every finished product batch or, “a subset of the finished dietary supplement batches that you identify through a sound statistical sampling plan to determine whether the finished product meets established product specifications for identity, purity, strength, and composition of the dietary supplement”
• Failure to clarify Standard Operating Procedures for final product testing.“Your records indicate that you performed microbiological tests on the finished product, but this type of test does not verify the identity, purity, strength, and composition of the finished product.”
• Failure to establish component specifications for, “Thiamine HCl, Riboflavin Phosphate, Pyridoxine HCl, Cyanocobalamin, Ascorbic Acid, Folic Acid, Niacinamide, D-Biotin, Calcium D-Pantothenate, Propylene Glycol USP, Glycerine 99.5%, Methylparaben, Propylparaben, Potassium Sorbate, Cremophor RH40, Triethanolamine, Aspartame, Orange Oil, and Purified Water”.
• Failure to identify ingredient identity testing protocols. “Your response does not specify, and you did not provide, supporting documentation on how you intend to ensure that you will verify the identity of each dietary ingredient used in the dietary supplements you manufacture.”
• Failure to establish and follow written procedures for, “calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement. Specifically, you did not have records of calibration for the scales used to weigh raw materials in the manufacturing of your dietary supplement products.”
• Failure to follow a written master manufacturing record (MMR) for each formulation and batch size
• Water use did not meet GMP requirements

Mama mia! FDA busts Abba for GMP and labeling violations