FDA Debuts List For Rapidly Announcing Noncompliant Ingredients In Supplements
FDA announces addition of Dietary Supplement Ingredient Advisory List page to its website to identify ingredients it has preliminary determined should be used in dietary supplements. It also publishes warning letters submitted recently to firms marketing supplements containing two ingredients agency has concluded should not be used: eight were warned about using an ingredient identified as "DMHA" and three about using phenibut.
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Align Supplement Industry Regulation With DSHEA, Groups Tell FDA In 'Responsible Innovation' Comments
Targeted guidance on questions around NDINs and using import alerts to keep violative products off market are among supplement industry trade groups' suggestions for improving FDA oversight of the industry. Groups also continue asserting that the agency can strengthen its VMS product manufacturing and marketing oversight with its existing authorities.
Agency announces plan in statement by two deputy commissioners warning consumers about safety concerns regarding the semi-synthetic derivative of vincamine, "specifically concerns about the use of this ingredient by women of childbearing age." Recent findings by NIH National Toxicology Program's study with rats and rabbits indicate "vinpocetine may cause a miscarriage or harm fetal development," FDA says.
FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.