"FDA regulates dietary supplements under a different set of
regulations than those covering "conventional" foods and drug products
(prescription and Over-the-Counter). Under the Dietary Supplement
Health and Education Act of 1994 (DSHEA), the dietary supplement
manufacturer is responsible for ensuring that a dietary supplement is
safe before it is marketed. FDA is responsible for taking action
against any unsafe dietary supplement product after it reaches the
market. Generally, manufacturers do not need to register their
products with FDA nor get FDA approval before producing or selling
dietary supplements.* Manufacturers must make sure that product label
information is truthful and not misleading.
FDA's post-marketing responsibilities include monitoring safety, e.g.
voluntary dietary supplement adverse event reporting, and product
information, such as labeling, claims, package inserts, and
accompanying literature. The Federal Trade Commission regulates
dietary supplement advertising."
"Overview" United States Food and Drug Administration
http://www.cfsan.fda.gov/~dms/supplmnt.html
Dietary supplements such as Berocca are treated as being foods for the
purpose of some aspects of import regulation. "Therefore, a facility
that manufactures, processes, packs, or holds dietary supplements for
consumption in the U.S. must register." "In addition to requiring the
registration of facilities, the Act requires that food and dietary
supplement importers provide the FDA with prior notice of imported
food shipments." "As mentioned above, dietary supplements and dietary
ingredients fall within the definition of ?food?. Thus, the prior
notice regulation applies to all dietary supplements and dietary
ingredients that are imported or offered for import for use, storage,
or distribution in the U.S. Also included are dietary supplements
imported for quality assurance/quality control samples, dietary
supplements imported for transshipment through the U.S. to another
country, supplements imported for future export, and dietary
supplements imported for use in a U.S. Foreign Trade Zone. The
regulation does not apply to dietary supplements that are imported
then exported without leaving the port of arrival until export."
"Terrorism Leads to New Food and Dietary Supplement FDA Registration
Requirements" by Steven A. Richards, Grimes & Reese (2003)
http://www.mlmlaw.com/saleswatch/fdabioterrorregs.html
Additional information can be obtained from the United States Food and
Drug Administration at "Food Facility Registration Questions and
Answers" (October 2003) http://www.cfsan.fda.gov/~furls/ffrmqa.html
and "What are the requirements for importing foods into the United
States?" http://www.cfsan.fda.gov/~dms/qa-ind2e.html.
The product's labeling must also comply with FDA regulations.
"Importers and foreign shippers should consult the regulations before
importing foods represented by labeling or otherwise as foods for
special dietary use. When foods for special dietary use are labeled
with claims of disease prevention, treatment, mitigation, cure, or
diagnosis, they must comply with the drug provisions of the Federal
Food, Drug, and Cosmetic Act, unless the claim is a health claim
authorized by regulation." "What are FDA requirements for Foods for
Special Dietary Use?" United States Food and Drug Administration
http://www.cfsan.fda.gov/~dms/qa-ind6a.html
The FDA provides considerable additional information regarding
labeling, voluntary dietary supplement adverse event reporting, and
other issues at: "Dietary Supplements" United States Food and Drug
Administration http://www.cfsan.fda.gov/~dms/supplmnt.html. The
"Questions and Answers" section at
http://www.cfsan.fda.gov/~dms/ds-faq.html may be of particular
interest to you.
In summary, the importation and sale of dietary supplements is legal
in the United States provided that importation and labeling
regulations are followed. This would require that the manufacturer of
Berocca and yourself, depending upon ownership, register all plants,
warehouses, and other facilities involved in the manufacture and
distribution of Berocca sold in the United States with the Food and
Drug Administration. You would also need to provide advance notice of
import to the Food and Drug Administration and ensure that the
product's labeling was legal for sale in the United States as a
dietary supplement.
Sincerely,
Wonko |
