The proposed Dietary Supplement Labeling Act of 2013 to amend the FFDCA and would require big changes to the industry, if the Act is passed.
On August 1, 2013 the Dietary Supplement Labeling Act of 2013 was proposed to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the registration requirements for a dietary supplement manufacturing or processing facility to:
(1) require the submission of a description, ingredient list, and label and labeling for each dietary supplement product manufactured or processed; and
(2) require a manufacturer to update its registration for new, reformulated, or discontinued products within 30 days.
The Dietary Supplement Labeling Act will require the FDA in partnership with the Institute of Medicine to compile a list of dietary supplement ingredients and proprietary blends of ingredients that may have potential to cause serious adverse events and require further risk evaluations. Another priority will be identifying proprietary blend ingredients for which the weight per serving of the ingredients in the proprietary blend will be listed on the label.
If a dietary supplement does not meet the requirements of the Dietary Supplement Labeling Act it will be considered adulterated or misbranded. However to date there has been no progress with the bill in congress and many trade organizations have expressed their concerns regarding the impact the bill will have on industry. At this point, it is likely that the bill will not be passed and dietary supplements will continue complying with DSHEA. Dicentra will ensure that updates are provided to inform you of any changes to the dietary supplement labeling regulations.
dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. We can be reached at 1-866-647-3279 or email@example.com.