Posted August 1, 2013

Maker of Algae Products Warned For Drug Claims, Manufacturing Violations

On March 8, 2013, the FDA issued a warning letter to Algaen Corporation following a facility inspection and website review which found statements made about the company's AlgaBerry products to be drug claims. 

AlgaBerry products were promoted for a variety of conditions, including inflammation and hypertension, with statements such as, "Modern studies have suggested that AlgaBerry may contain a broad range of compounds that have anti-microbial, anti-viral, anti-tumor, or anti-cancer activity." 

AlgaBerry is described as an edible blue-green alga used as a dietary supplement "source of vitamin A, calcium, iron protein, and polysaccharides." 

(See's Review of Greens and Whole Foods Powders and Pills for tests of related products and see Reviews of Vitamin A Supplements, Calcium Supplements, Iron Supplements and Protein Supplements for tests of products that contain these ingredients.)

The company's products, including Spirulina Powder, were also found to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. 

These violations include failure to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement and failure to establish and follow written procedures for the responsibilities of the quality control operations.

To read the FDA's warning letter, use the link below.