2010 Dietary Supplement Safety Bill

One hears many complaints by the supplement industries for the prevention of regulatory services, however what is the truth? In this entry rather than pose an opinion I will provide the key concepts within the bill and leave it up to the readers to decide their opinion.


2010 Dietary Supplement Safety Bill [pdf - 41.10 kb]

To amend the Federal Food, Drug, and Cosmetic Act to more effectively regulate dietary supplements that may pose safety risks unknown to consumers.

FACILITIES
‘‘(i) IN GENERAL.—A dietary supplement facility (referred to in the section as a ‘dietary supplement registrant’) shall submit a registration under paragraph (1) to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the dietary supplement registrant conducts business. At the time of registration, the dietary supplement registrant shall also file with the Secretary a list of all dietary supplements manufactured, packaged, held, distributed, labeled, or licensed by the facility. Such list shall be prepared in such form and manner as the Secretary may prescribe, and shall be accompanied by a full list of the ingredients contained in each dietary supplement, and a copy of the labeling used by the facility for each dietary supplement.

‘‘(ii) UPDATES.—
Each dietary supplement registrant shall update the registrant’s registration annually on or before the anniversary date of the registrant’s initial registration. Each dietary supplement
registrant shall also update the registrant’s registration to include information regarding any new dietary supplement, or reformulation of an existing dietary supplement, on or before the date such dietary supplement is marketed for consumption in the United States.’’; and (ii) in paragraph (3), by inserting ‘‘or dietary supplement registrant’’ after ‘‘notify the registrant’’.

NEW DIETARY INGREDIENTS.
IN GENERAL.—A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless there is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. The Secretary shall keep confidential any information provided under this subsection for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information.’’

‘‘(a) RECALL AUTHORITY.—
13 ‘‘(1) CEASE DISTRIBUTION AND NOTIFICATION
14 ORDER.—
15 ‘‘(A) IN GENERAL.—If the Secretary finds there is a reasonable probability that a dietary supplement or a product marketed or sold as a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or misbranded, the Secretary shall issue a cease distribution and notification order requiring the person named in the order to immediately—
'‘(i) cease distribution of such dietary supplement or a product marketed or sold as a dietary supplement;‘
''(ii) notify distributors, importers, retailers, and consumers of the order; and
‘‘(iii) instruct those distributors, importers, retailers, and consumers to cease distributing, importing, selling, and using the dietary supplement.