AHPA Alerts

Since February 21, 2014, the Food and Drug Administration (FDA) has performed four enforcement actions advising consumers not to purchase or use products because FDA laboratory analysis confirmed that these products contain undeclared ingredients.

Using stevia to reformulate just 20% of carbonated soft drinks could slash more than 6,000 calories per year from the diet of consumers, says Diana Cowland of Euromonitor International. 

 The products are packaged in clamshell, zip sealed packets and green pill bottles, 4, 10, 20, and 40 count. The products can be identified by their bright green packaging and label which states that it contains Kratom. The products were sold to wholesale distributors in the following states: Alabama, California, Illinois, Missouri, Kentucky, Florida, Oklahoma, Idaho, Colorado, Wisconsin, Massachusetts, and Ohio. The products were further distributed by those entities. SNI National has completely terminated distribution.

Since January 24, 2014, the Food and Drug Administration (FDA) has performed 16 enforcement actions advising consumers not to purchase or use products because FDA laboratory analysis confirmed that these products contain undeclared ingredients.

On March 11, 2014, Senomyx, Inc. issued a public statement suggesting that its food ingredient Sweetmyx (also known as S617) was generally recognized as safe (GRAS). The statement appeared to suggest that the U.S. Food and Drug Administration (FDA) had made the GRAS determination. In fact, the agency had not made this determination nor had it been notified by Senomyx regarding a GRAS determination for this food ingredient. The  company's statement has been corrected and now notes that a third party organization made the determination.

Changes made to state laws have opened the door for certified herbal therapists to prescribe custom Chinese herbal therapy blends and traditional formulas to patients within a clinical practice.

Reason for Alert:   FDA has seen an increase in the number of shipments of dietary supplements and bulk dietary ingredients that are, or contain kratom, also known as Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang. These shipments of kratom have come in a variety of forms, including capsules, whole leaves, processed leaves, leaf resins, leaf extracts, powdered leaves, and bulk liquids made of leaf extracts. Importers' websites have sometimes contained information about how their products are used.

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on the Over-The-Counter (OTC) Drug Review (sometimes referred to as the OTC Monograph Process, OTC Monograph, or OTC Drug Review). The Agency would like input on how to improve or alter the current OTC Monograph Process for reviewing nonprescription drugs (sometimes referred to as OTC drugs) marketed under the OTC Drug Review. This public hearing is being held to obtain information and comments from the public on the strengths and weaknesses of the current OTC Monograph Process, and to obtain and discuss ideas about modifications or alternatives to this process.

Summary

The FDA's proposed rule would require those who transport food to use sanitary transportation practices to ensure the safety of food.