New Requirements from Suppliers to Retailers
Suppliers and retailers regardless of size all along the chain of commerce are required to “obtain adequate written evidence” from the seller that the product is registered as required. That evidence must be retained in a file available for inspection.
Adverse Event Reporting (AER)
Requires reporting of all adverse events, not just serious adverse events. In addition, a compilation of non-serious AERs must be submitted annually, and records must be maintained for three years.
“Accepted Dietary Ingredients” List
Mandates creation by the Secretary of a list of “Accepted Dietary Ingredients” to replace the current “in commerce pre-DSHEA” test.
New Dietary Ingredients (NDI)
NDIs are considered adulterated unless there is a history of use or evidence of its safety. Registrants shall maintain a “scientifically reasonable substantiation file” available for inspection by the Secretary of Health and Human Services. Registration required 75 days prior to market.
Provides immediate recall authority to the Secretary upon determination that a supplement “would cause serious, adverse health consequences or death, or is adulterated or misbranded.” Companies subject to a recall have the right to challenge the order in an “informal hearing” within 10 days. At their own expense, retailers must notify customers of such recalls.
Registration of Dietary Supplement Facilities
Dietary supplement facilities shall register with the Secretary (required information includes name, address of all facilities, trade names, list of supplements, their ingredients, and labels). Registration is annual.