FDA Takes Swedish Bitter Herbs to Task

CONCORDIA, Mo.FDA issued a strong warning to Swedish Bitter Herbs Co., after the company responded to the FDA 483 observations issued after an inspection of the companys Missouri-based manufacturing facility in early July. FDAs Southwest Region, Kansas City District Office, issued the Nov. 8 warning letter citing not only concerns about the inadequacies of the companys response to the 483 observations, but also issues with the marketing and labeling of several products that would position them not as dietary supplements but as new and/or unapproved drugs.

During the July 6 to 14 inspection, FDA found several violations of 21 CFR Part 111, the cGMPs (good manufacturing practices) for dietary supplements. While Swedish Bitter Herbs did respond on July 16, FDA found several of the responses inadequate. For example, while the company stated it did not believe it needed to test all dietary ingredients because the ingredients are GRAS (generally recognized as safe) and carry a certificate of analysis (C of A) from the supplier, FDA responded that federal regulations require testing to verify identity of all dietary ingredients. Similarly, Swedish Bitter Herbs stated it was not testing all finished products for identity, purity, strength and composition because the costs would be prohibitive; FDA noted the testing is a federal requirement. Other concerns related to a lack of written master manufacturing records (MMR) for formulations; lack of batch production records; failure to establish written quality control operations; and failure to clean and sanitize equipment.

Further, FDA cited the firm for marketing unapproved new drugs, and misbranding drugs and dietary supplements. The agency referred to claims for Swedish Bitters, Heart Food Drops (natural support for heart disease/stroke sufferers") and Small Flowered Willow Herb that cause the products to be considered drugs; as they are not approved for their marketed uses, they are new drugs and misbranded as they lack adequate directions for use. Also, while Swedish Bitter Herbs claimed several of its products are (conventional) foods and not dietary supplements, at least two products are specifically labeled as dietary supplements. However, Maria Trebens Authentic Swedish Bitters, Alcohol (38% by Vol.) and Bull Natural Concentrated Pump do not carry appropriate nutrition and supplement labeling.

In its warning letter, FDA requested a response within 15 working days outlining the specific actions the company will take to correct the violations and prevent similar violations in the future, and should include appropriate documentation including revised labels, logs and procedures. Failure to comply with federal regulations could result in enforcement action including seizure and/or injunction.