106 
Again, however, these quarantine sections relate only to the shipment of prod- 
ucts rather than the uses to which they are put. It is suggested that even if that 
requirement is met, the Secretary of HEW has no authority to regulate DXA prod- 
ucts until they have already been determined to be a "source of dangerous infec- 
tion to human beings.” 
The Federal Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq., provides 
authority for regulation of the manufacture and interstate transportation of 
drugs and new drugs. Drug means (among other things) ‘‘articles (other than 
food i intended to affect the structure or any function of the body of man or other 
animals.” 21 U.S.C. 321 (g)(1)(c). The definition also includes "any material 
used as a component of such a drug,” such as component raw materials. United 
States v. Dianovin Pharmaceutical, Inc., 475 F.2d 100 (1973), cert. den. 424 U.S. 
S30. Provided that products of DXA research are intended for use as a drug 
product or as a component thereof, and will be introduced into interstate com- 
merce, then they will be subject to the Act’s requirements. 
The Consumer Product Safety Act, 15 U.S.C. 2051 et seq., is unlikely to have 
any utility in the regulation of either DXA research or its resulting products. A 
consumer product must be just that, one intended “for sale to a customer for use 
in ... a residence, a school, in recreation ... or (ii) for personal use, consumption, 
or enjoyment of a consumer” under the same circumstances. 15 U.S.C. 2052(1). 
Thus, before any DX'A research product is likely to be subject to the provisions 
of this Act, it very probably will have had to meet more stringent requirements 
under one or more of the other Acts described in this report. 
To conclude, our review of the statutes discussed above suggests that one or 
more questions need to be asked to determine if the particular DXA. research 
activity, and its products, are subject to regulation under current federal law. 
One of two threshold requirements must be met in order for the activtity to be 
subject to any of the laws : 
(1) Is the activity federally funded? 
(2) Does the activity bear any relationship to interstate or foreign com- 
merce? or is it an entirely private, local endeavor? Do the end products,- or 
components thereof, enter commerce or affect commerce? 
Some other, more specific, questions are : 
(3) Is the research activity being conducted with a specific identifiable 
purpose? For what are its products intended? 
(4) Does the activity present an “unreasonable risk?” 
Even where the research is determined to be subject to one or more federal 
laws, it will be dependent on the specific nature of the activity involved. Current 
law, as we indicated at the outset of this report, does not provide for comprehen- 
sive regulation of DXA products. If this is to be accomplished additional legisla- 
tion is necessary. 
We hope the information provided is helpful. Should you require additional 
information or materials please feel free to contact us. 
Donna C. Pabratt, Legislative Attorney. 
o 
[Appendix B — 365] 
