On June 8, 1999, President Clinton signed into law amendments that will vastly overhaul the Fastener Quality Act (the "FQA" or the "Act"), narrowing the Act's scope and simplifying its procedures. The amendments, codified as P.L. 106-34, follow a report by the Secretary of Commerce released February 25, 1999, recommending significant amendments to the FQA. Had the amendments not taken effect, the earlier version of the Act would have gone into effect later this month.
That earlier version of the Act would have affected over half of all fasteners sold in the United States, and imposed heavy record keeping and segregated storage burdens upon manufacturers, importers and some distributors. The new amendments will save the automobile industry alone an estimated $330 million annually in compliance costs. Automobile industry representatives testified to Congress earlier this year that implementation of an earlier version of the Act could possibly have also delayed automobile production in the United States. P.L. 106-34 significantly lowers the costs of compliance with the Act, primarily by cutting the number of fasteners the FQA covers.
P.L. 106-34's Amendments
The new FQA amendments define "fastener" to exclude the majority of fasteners on the market today, including:
. fasteners that are part of an assembly;
. fasteners under the jurisdiction of the Federal Aviation Administration or a foreign airworthiness authority;
. fasteners that are ordered for use as a spare, substitute, service or replacement part unless that part is in a package containing more than 75 of such a part at the time of sale,
or that is a part contained in an assembly kit;
. fasteners produced and marked as ASTM A 307 Grade A, or a successor standard thereto;
. fasteners produced in accordance with ASTM F 432, or a successor standard thereto;
. fasteners manufactured in accordance with a fastener quality assurance system comparable to the International Organization for Standardization (ISO) 9000; and
. fasteners manufactured to a proprietary standard, whether or not that proprietary standard directly or indirectly references a consensus standard or any portion thereof.
The amendments also reduce paperwork obligations for fasteners that remain subject to the Act, allowing for electronic storage and transfer of records on fastener quality. Finally, the amendments provide for the establishment of a hotline for reporting alleged violations of the FQA.
that because neither Cholestin nor lovastatin has been approved by FDA as a finished drug product, Pharmanex was not precluded from selling Cholestin as a dietary supplement.
Implications of Decision
It appears from FDA's recent actions, including the position it took in the Pharmanex case, that the FDA is attempting to narrow the universe of permitted dietary supplements. On one front, the Agency appears to be trying to force some dietary supplements into the category of traditional foods . for example, the Agency's well-publicized efforts to require plant sterol-containing spreads to be marketed as traditional foods rather than dietary supplements in conventional food form. On another front, the Agency is seeking to restrict the scope of claims for dietary supplements so that claims that appear to be permitted under DSHEA may render the products unapproved new drugs rather than dietary supplements. It is important to note that the Agency has greater regulatory authority over traditional foods and drugs than over dietary supplements. The 10th Circuit Court of Appeals' decision in the Pharmanex case is likely to affect the way the FDA formulates its strategy for regulating dietary supplements in the future.