FDA AND THE PUBLIC INTEREST: QUALITY
CONTROL IN SCIENTIFIC AND ECONOMIC
REGULATION
Eugene I. Lambert*
The Food and Drug Administration exercises more regulatory
power affecting the daily activities of the consumer than any other
Federal agency.' Its responsibility includes both the maintenance of
safety of food2 and the maintenance of "pocketbook" protection
against misleading labeling and economic debasement? It controls the
manufacture, marketing and labeling of prescription and
nonprescription drugs, 4 scrutinizes the effects of household chemical
products,5 regulates the importation of milk and tea, 6 and enforces,
for foods, drugs, devices and cosmetics, the Fair Packaging and
* Member of the Bar of the District of Columbia; Associate, Covington & Burling,
Washington, D.C.
I. The principal act administered by the Food and Drug Administration is the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. §§ 301-92 (1964). The principal amendments include the
Miller Pesticides Amendment of 1954, 68 Stat. 511, the Food Additives Amendment of 1958, 72
Stat. 1784, the Color Additives Amendment of 1960, 74 Stat. 397, the Drug Amendments of
1962, 76 Stat. 780, the Drug Abuse Control Amendments of 1965, 79 Stat. 226, and the Animal
Drug Amendments of 1968, 82 Stat. 342.
All activities under the Drug Abuse Control Amendments (except detection of counterfeiting
noncontrolled drugs) were transferred from FDA to the Bureau of Narcotics and Dangerous
Drugs in the Department of Justice, simultaneously with the transfer of narcotics laws
enforcement from Treasury. Reorganization Plan No. I of 1968, 33 Fed. Reg. 5611 (1968).
2. Food, Drug, and Cosmetic Act, 21 U.S.C. § 342(a) (1964), deals with traditional concepts
of adulteration-filth, poisonous substances and decomposition. 21 U.S.C. § 346 (1964), 21
U.S.C. § 346a (1964), and 21 U.S.C. § 348 (1964), deal with modern technical problems of
safety with respect to pesticides, intentional food additives, packaging materials, and irridated
foods.
3. 21 U.S.C. § 343(a) (1964), prohibits labeling that is false or misleading in any particular,
including the failure affirmatively to disclose relevant information 21 U.S.C. § 321(n) (1964),
while 21 U.S.C. § 342(b) (1964) and 21 U.S.C. § 343(c) (1964), are directed toward economic
cheating-the use of fillers and palming off.
4. In addition to the requirements imposed by the Act and the implementing regulations with
respect to labeling claims, ingredient information, and adequate directions for use, 21
U.S.C. §§ 352(a), (e), () (1964), the Food and Drug Administration has detailed licensing
control over those drugs not generally recognized as safe and effective for their intended uses. 21
U.S.C. §§ 321(p), 355 (1964), are authorities that provide for complete review of all steps in
the animal and human testing of a drug prior to marketing, its labeling and composition, as well
as continuing surveillance of reported reactions to the drug's general public use. See 21
C.F.R. §§ 130.3, 130.3a, 130.4, 130.9, 130.13 (1968). See 21 U.S.C. §§ 361, 362 (1964).
5. Federal Hazardous Substances Labeling Act, 15 U.S.C. §§ 1261-74 (1964), as amended,
(Supp. I1, 1965-67).
6. Federal Import Milk Act, 21 U.S.C. §§ 142-49 (1962). Tea Importation Act, 21
U.S.C. §§ 41-50 (1964).
THE AMERICAN UNIVERSITY LA W REVIEW
[Vol. 18
Labeling Act.7 Despite the broad impact of its regulation, however,
the Food and Drug Administration, as an administrative creation
without independent agency status,s has only within the past few years
gained the public attention and financial support necessary to
discharge its manifold duties.' Having achieved such recognition and
support, FDA now has the obligation to apply principles of "quality
control"-the scientific accumulation of data and reduction of output
variability around a pre-defined goal-to its operations so as to
protect those regulated from ad hoc, ill conceived, or unfounded
judgments, and to protect the consumer to the full extent of the
statutory requirements. An examination of (1) the impact of FDA
regulation, (2) the scientific control of consumer goods, and (3) FDA
economic regulation will serve to illustrate the need for judgmental
quality control. Special emphasis will be given to the use of consumer
surveys as a prime tool in the achievement of judgmental quality
control in the area of economic regulation.
IMPACT OF REGULATORY ACTION
General Characteristics
The development of scientific methods of regulation has not always
kept pace with the broad expansion of FDA regulatory responsibility.
The traditional focus of FDA concern has been on the area of health,
7. 15 U.S.C. § 1451 (Supp. II, 1965-67). The Fair Packaging and Labeling Act does not
apply to prescription drugs or insulin-containing drugs. 15 U.S.C. § 1459(a)(3) (Supp. II1, 196567). The provisions of the Act with respect to retail consumer commodities other than foods,
drugs, devices and cosmetics are implemented and enforced by the Federal Trade Commission.
15 U.S.C. § 1454(a) (Supp. II!, 1965-67).
8. The Food and Drug Administration was the agency within the Department of Agriculture
charged with the administration of the Food and Drugs Act of 1906, Pub. L. No. 59-384, 34
Stat. 768 (1906), see Pub. L. No. 69-552, 44 Stat. 976 (1927), and the administration of the
1938 Act was originally given to the Secretary of Agriculture, see Sections 201(c), (d), 52 Stat.
1040 (1938). By Presidential Reorganization Plan, the Food and Drug Administration became
one of the constituent organizations of the Federal Security Administration, and its head became
known as the "Commissioner of Food and Drugs." Reorganization Plan No. IV, 54 Stat. 1237
(1940). In its turn, the Federal Security Administration was reorganized into the Department of
Health, Education, and Welfare, Reorganization Plan No. I of 1953, 67 Stat. 631 (1953). And
in 1968 the Secretary of HEW created a new Consumer Protection and Environmental Health
Service in which the Food and Drug Administration was one of three constituent organizations,
reporting to the Secretary through the administrator of CPEHS and the Assistant Secretary. 33
Fed. Reg. 4894, 9909 (1968).
9. The budget requested for FDA in fiscal 1963 was $28,400,000. In contrast, FDA received
$66,000,000 for fiscal 1968. A general review of FDA's growth in manpower and budget, when
measured against responsibilities, may be found in FDA's 1967 Look After 60 Years of
Reorganization, FDA Papers, Feb. 1967, at 9. An approximately twelve-fold increase in the
budget occurred between 1955 and 1967.
1968]
FDA AND PUBLIC INTEREST
pursuant to the standards of the "pure" food and drug laws.' 0 The
early prohibitions were against simple filth and contamination in
various products" and against patently dangerous chemicals. 2 The
extension of FDA powers under the 1938 Federal Food, Drug, and
Cosmetic Act' 3 and particularly the Pesticide Chemicals Amendment
of 1954 4 and the Food Additives Amendments of 1958,'" made health
regulation much more sophisticated. FDA now has power'to fix
tolerances for chemical additives and to license their use on a food-byfood basis. 6 In the "pure" food area, FDA is concerned with the
problems of environmental contamination and intentional and
incidental additives.'
FDA inspectors regularly visit food and drug
manufacturers, wholesalers and others in the chain of distribution,"
obtaining samples and making determinations concerning
10. The term "pure" does not appear as such in the name of any of the Acts. The concept is
used specifically with respect to drugs that are required to meet either a compendium or a selfasserted test of purity, e.g., Food and Drugs Act § 7 ch. 3915, 34 Stat. 770 (1906); 21
U.S.C. §§ 321(s), 349 (1964)).
II. Food and Drugs Act § 7, ch. 3915 Food: Sixth, 34 Stat. 768 (1906) (repealed 1938).
lz. Id. § 7, Confection.
13. See 21 U.S.C. § 346 (1964).
14. Ch. 559, 68 Stat. 511 (1954) (codified principally in 21 U.S.C. §§ 321(q), (r), 346a
1964)).
15. Pub. L. No. 85-929, § 2, 72 Stat. 1784 (1958) (codified principally in 21 U.S.C. §§ 321(s),
349(1964)).
16. Under 21 U.S.C. § 346 (1964), specific tolerances could be fixed for added substances
either "required" in the manufacture of the food or that could not be "avoided by good
manufacturing practice" in such manufacture. FDA also created informal tolerances by
recognizing specific levels of additives that would ndt be deemed "poisonous or deleterious."
Under the Food Additives Amendment a tolerance can be imposed on the use of any food
additive if required to assure its safe use. 21 U.S.C. § 348(c)(4) (1964). The "license" issued is
a public regulation codified in 21 C.F.R. Part 121 (1968).
17. 21 U.S.C. § 342(a)(4) (1964), renders a food adulterated if it has been "prepared, packed
or held under unsanitary conditions whereby it may have become contaminated with filth."
Comparable provisions exist for drugs and cosmetics, 21 U.S.C. §§ 351(a)(2)(A), 361(c) (1964).
FDA also regulates residues of pesticide chemicals certified as useful for use on growing crops
by the Secretary of Agriculture, when such residues remain on raw agricultural commodities.
See 21 U.S.C. § 346a (1964); 21 C.F.R. Parts 120, 121 (1968).
18. FDA's power to demand entry into food and drug manufacturing and distribution
facilities is found in 21 U.S.C. § 374 (1964). The Constitutional status of mandatory factory
inspection where the results of the inspection may lead to criminal prosecution today is in doubt
following the Supreme Court's decision in See v. Seattle, 387 U.S. 541 (1967), holding that
"administrative entry, without consent, upon the portions of commercial premises which are not
open to the public may only be compelled through prosecution or physical force within the
framework of a warrant procedure." Id. at 545. The Court specifically reserved its views on the
constitutionality of Section 374. Id. at 544. The FDA response was to prepare for the use of
"inspection warrants" in the event of inspection refusals. FDA Press Release No. 67-74, June
18, 1967; see Vinz, The Conipleat Inspector, FDA Papers, at 4, 6 (Sept. 1968).
THE AMERICAN UNIVERSITY LA W REVIEW
[Vol. 18
contamination and the improper use of additives.' 9 Thus, a substantial
portion of FDA regulatory activity continues to be the removal from
the market place of contaminated foods and drugs or those containing
20
additives in excess of permitted level.
FDA also has important powers of economic regulation arising
from Section 401 of the Federal Food, Drug and Cosmetic Act, which
authorizes the issuance, when it will "promote honesty and fair
dealing in the interest of consumers," of reasonable definitions and
standards of identity for foods, standards of quality for foods, and
standards of fill of containers. 2' The establishment of the concept of
"defining" a food-describing its nature, composition and appropriate
limitations-antedates the current Act, 22 but Section 401 transformed
the concept into an essential element in FDA regulation,23 thus
involving the agency in the control of the composition of foods and
leading to significant decisions for manufacturers and consumers.
FDA control over economic aspects of the market place is augmented
by the Fair Packaging and Labeling Act,24 which provides that the
agency may, in the interest of prevention of consumer deception and
of facilitation of value comparisons, establish characterizations (such
as "small," "medium," "large," and "family") for sizes used in
packaged commodities, regulate the use of "cent-off" offers, require
ingredient disclosure on drugs and cosmetics beyond that required by
the Federal Food, Drug, and Cosmetic Act, and can prevent what is
known as the "nonfunctional-slack-fill of packages." 2
19. The nature of the inspection process and the use of analytical techniques are detailed in
Bassen, The Establishment Inspection, FDA Papers 10 (July-Aug. 1968) and Shelton, The
Changing Concept of Food Sanitation, FDA Papers 12 (Oct. 1967); Vinz, supra note 18.
20. A review of seizures and notices of judgment published in FDA's official magazine, FDA
Papers, shows continuing heavy emphasis on seizure actions involving injurious additives,
contamination, spoilage or insanitary handling.
21. 21 U.S.C. § 341 (1964).
22. The original concept derived from the McNary-Mapes Amendment of 1930 to the Food
and Drugs Act of 1906, Pub. L. No. 71-538, 46 Stat. 1019. It authorized the Secretary of
Agriculture to establish standards of quality, condition or fill of container for canned foods. The
1938 Act extends the authority to the broader concept of "definition and standard of identity"
and makes it applicable to all foods with the exception of fresh and dried fruits and vegetables.
See generally, Security Adm'r v. Quaker Oats Co., 318 U.S. 218 (1943); Libby, McNeil &
Libby v. United States, 148 F.2d 71 (2d Cir. 1945); Austern, The Formulation of Mandatory
Food Standards, 2 FOOD DRUG CosNi. L.Q. 532 (1947).
23. A food violating a standard of identity, quality or fill is misbranded under the Act 21
U.S.C. §§ 343(g), (h) (1964).
24. 15 U.S.C. § 1451 (Supp. III, 1965-67). This Act provides both mandatory and
discretionary authority with respect to the labeling of products sold at retail for household use in
the areas of identity, net quantity statements, manufacturer identification, non-functional slack
fill, and label price offers.
25. 15 U.S.C. § 1454(c) (Supp. III, 1965-67). The Food, Drug, and Cosmetic Act presently
1968]
FDA AND PUBLIC INTEREST
Sanctions
The Food and Drug Administration has a somewhat unique array
of sanctions with which to enforce a statute or regulations issued
pursuant thereto.26 For example, if wheat contains rodent droppings,"
or the tolerance of DDT is exceeded,2" or the percentage of cocoa fat
in breakfast cocoa runs 3%low,29 or a margarine label says soybean
and cottonseed oil but the margarine contains some corn oil as well,3"
the products may be seized, condemned, and destroyed;3 the producer
may be enjoined from producing a single bottle, jar, or can in its
plants until FDA and the court can be satisfied that the error has
been corrected;32 and corporate officers can be criminally prosecuted.33
Each of these sanctions is cumulatively available for every violation of
proscribes the use of containers made, formed or filled as to be misleading, 21
U.S.C. §§ 343(d), 352(i)(1), 362(d) (1964). The rulemaking authority is in part a reflection of
FDA's lack of success in court enforcement of prior statutory provisions. E.g., United States v.
174 Cases of Delson Thin Mints, 180 F. Supp. 863 (D.N.J. 1960), vacated, 287 F.2d 246 (3d
Cir. 1961), on remand, 195 F. Supp. 326 (D.N.J. 1961), affd per curiam, 302 F.2d 724 (3d Cir.
1962); Note, 72 YALE L.J. 788 (1963).
26. The Wholesome Meat Act, Pub. L. No. 90-201, 81 Stat. 584 (1967), which made a
wholesale revision in the authority of the Department of Agriculture with respect to meat
inspection, expanded the penalties under the Meat Inspection Act to include the three-fold
sanctions of seizure, injunction and criminal penalties previously available only to the Food and
Drug Administration. See Federal Meat Inspection Act, 21 U.S.C. §§ 673, 674, 676 (Supp. III,
1965-67).
27. FDA, Notices of Judgment, F.N.J. Nos. 30518-25 (Oct. 1966).
28. 21 C.F.R. §§ 120.147, 121.1093 (1968).
29. 21 C.F.R. § 14.3 (1968).
30. 21 C.F.R. § 45.1(b) (1968).
31. Each of the foregoing examples covers a form of either adulteration or misbranding. The
violation is created by 21 U.S.C. § 331(a) (1964), which makes it unlawful to introduce or
cause the introduction of an adulterated or misbranded food into interstate commerce. Since the
jurisdictional element is the use of interstate commerce, prohibitions also attach to causing
adulteration while in commerce, receipt and proffered delivery of adulterated or misbranded
goods, and causing adulteration or misbranding after interstate shipment and while held for sale.
21 U.S.C. §§ 331(b), (c), (k) (1964). The seizure action, 21 U.S.C. § 334(a)(1) (Supp. III,
1965-67) is essentially an admiralty in rem procedure, but if the goods are claimed, the
procedure is treated essentially as a civil action. See United States v. Bottles . . . Sudden
Change, 36 F.R.D. 695 (E.D.N.Y. 1965); cf 443 Cans v. United States, 226 U.S. 172 (1912)
(1906 Act). With the coalescence of the admiralty practice with the Federal Rules of Civil
Procedure in 1966, the issue is largely mooted. See United States v. Bottles . . . Sudden
Change, 288 F. Supp. 29 (E.D.N.Y. 1968).
32. 21 U.S.C. § 332(a) (1964); e.g., FDA, Notices of Judgment, F.N.J. No. 30517 (Oct.
1966).
33. 21 U.S.C. § 333(a) (1964); e.g., United States v. Colosse Cheese & Butter Co., 133 F.
Supp. 953 (N.D.N.Y. 1955). Despite FDA requests to the contrary, S. ReP. No. 1186, 89th
Cong., 2d Sess., 15-16 (1966), criminal sanctions cannot be imposed for those provisions of the
Fair Packaging and Labeling Act enforced by FDA. 15 U.S.C. 1456(a) (Supp. III, 1965-67).
THE AMERICAN UNIVERSITY LA W REVIEW
[Vol. 18
the Act, from the intentional poisoning of a food to the use of white
type on a package of marshmallows.34 Furthermore, the impact of
such sanctions is made more severe by the application of the doctrine
of absolute liability." If, contrary to specific directives from the
corporation and despite careful supervision, for example, a standard
of fill is not met, liability may be imposed on both the actual
perpetrators of the violation and upon the corporate officers as well? 6
In addition to judicial sanctions, the agency has a variety of
administrative sanctions available. The Act provides for the holding
of informal hearings as a prelude to the institution of criminal
proceedings,37 and this informal hearing procedure is regularly used to
gain compliance with the agency's regulatory goals.3" Despite their
supposed informal nature,39 the proceedings are carefully recorded and
the record is transmitted to Washington for review. One of the
curious aspects of this administrative hearing is that the results are
usually known only by inference-if you are indicted you were
unconvincing, while if you hear nothing you may conclude that the
40
matter was shelved.
The agency also uses its regulations for purposes of compliance.
For example, regulations issued under the Federal Food, Drug, and
Cosmetic Act and those issued under the Fair Packaging and
Labeling Act specify the manner in which food products are to be
42
identified,4' and the method of stating the net quantity of contents
34. See United States v. Gramer, 191 F.2d 741 (9th Cir. 1951).
35. United States v. Dotterweich, 320 U.S. 277 (1943); see, Austern, Expertise in Vivo. 15
AD. L. REV. 46 (1963).
36. United States v. Dotterweich, 320 U.S. 277 (1943); Golden Grain Macaroni Co. v.
United States, 209 F.2d 166 (9th Cir. 1953); United States v. Diamond State Poultry Co., 125
F. Supp. 617 (D. Del. 1954). 21 U.S.C. § 333(b) (1964), as amended, (Supp. Ill, 1965-67),
allow the penalties to be doubled for intentional violations.
37. 21 U.S.C. § 335 (1964).
38. This procedure has been criticized, Austern, Sanctions in Silhouette, 51 CALIF. L. REV. 38
(1963), but could also be viewed as a means of implementing 21 U.S.C. § 336 (1964) that
provides that minor violations need not be reported for the institution of formal sanctions
whenever FDA "believes that the public interest will be adequately served by a suitable written
notice or warning," such as the citation procedure provides.
39. 21 C.F.R. § 1.6(a) (1968): Presentation of views under Section 305 of the act [21
U.S.C. § 335 (1964)] shall be private and informal.
40. At times, the results become known through congressional inquiries, e.g., Hearings on
Drug Safety Before a Subcomm. of the House Comm. on Government Operations, 89th Cong.,
1st Sess., 4, at 1456-70 (1966), an FDA list of recalls, includes the disposition of citations issued
under Section 305 of the Act.
41. 21 C.F.R. § 1.8 (1968).
42. 21 C.F.R. § 1.8b (1968).
1968]
FDA AND PUBLIC INTEREST
and of identifying the manufacturer, packer, or distributor. 3 The
regulations are sometimes binding on the manufacturer, while in other
instances they serve merely as guidelines." Mandatory or not,
however, such regulations often serve to threaten industry into the
performance patterns the Food and Drug Administration desires, and
for this reason it is important that there not be a consistent variation
between the requirements of a regulation and the actual enforcement
practice of the agency, or a kind of "credibility gap." 4 5 Such
variations result from the lack of judgmental quality control.
Finally, the agency utilizes the public press to effectuate an
"informal sanction." The well-known cranberry case and the impact
on specific brands of the announcements on the recall of nonfat dry
milk products4 6 are good examples of the effect of FDA public
pronouncements. Legislation has been proposed to remedy the
deficiency in judgmental quality control manifested by the issuance of
loud public warnings which are disproportionate to the scope of the
are unrealistic in terms of the ability of
particular problem and which
47
manufacturers to comply.
43. 21 C.F.R. § 1.8a (1968).
44. 21 C.F.R. § 1.1(c) indicates those provisions in the labeling regulations having
mandatory effect under the Fair Packaging and Labeling Act. Other provisions, e.g., Section
1.10, while framed in directive terms, state FDA's interpretation of 21 U.S.C. § 343(i) (1964),
mandatory powers over food ingredient labeling having been omitted from the scope of FDA's
authority under the Fair Packaging and Labeling Act, 15 U.S.C. § 1454(c)(3) (Supp. III, 196567).
45. The charge of just such a gap between advice and practice has been leveled against FDA,
e.g., Austern, supra note 38, at 41, and as a result some practitioners suggest that the most
valuable advice that can be given to a client is when not to consult the agency. The undesirable
effects of such a disparity were aptly stated by FTC Chairman Dixon:
You don't dare, Mr. Chairman, idly put out guidance or do preaching to people unless you
are going to follow through on compliance, because you might persuade 98 percent to take
your guidance and 2 percent won't, and if you don't do something about it then they will
have to rejoin it competitively.
Hearings on Drug Safety before a Subconz. of the House Comm. on Government Operations.
89th Cong., 2d Sess., 5, at 2111 (1966).
46. Representative news stories can be found in the Washington Post, Nov. 6, 1966, at BI,
and the Washington Evening Star, Nov. 3, 1966, at A3. When the company involved again
commenced sale of non-fat dry milk it did not use the former brand name. The scientific work that
traced cases of salmonellosis back to a non-fat dry milk producing plant can be found in Collins
et al., Interstate Outbreak of Salmonella newbrunswick Infection Traced to Powdered Milk, 203
J.A.M.A. 838 (1968). See generally Austern, Is Government by Exhortation Desirable?, 22 FoOD
DRUG Cosw. L.J. 647 (1967).
47. S. 924, 90th Cong., IstSess., introduced by Senator Dirksen, which woula have made
prehearing publicity potential prejudicial error unless the person charged had "been given an
equal opportunity to publicize his comments at the same time and in the same document in
which the agency publicity was issued."
THE AMERICAN UNIVERSITY LA W REVIEW
[Vol. 18
In view of the broad range of regulatory authority and the drastic
effects that the regulation can have, it is clear that FDA has a
continuing obligation to re-examine its regulatory methods and its
decision-making process so that agency positions are not arbitrarily
determined.
THE SCIENTIFIC ASPECTS OF REGULATION
As indicated, FDA regulation of industry is extensive, and
judgmental quality control is essential to the fairness of this regulation.
But judgmental quality control is also vital in the product
examinations conducted by FDA in the interest of protecting the
consumer, particularly in the food area. Unlike the purchase of drugs,
in which an informed decision can usually be made by the consumer"
or his physician, 49 the purchase of food presents the problem of
additives, of which the consumer has little knowledge and over which
he has no control. While intentional additives must ordinarily be
specified on the label, purchasing decisions are rarely predicated on an
examination of the ingredient listing or on the presence or absence of
technical ingredients."
Moreover, the consumer cannot control his
exposure to incidental additives, such as packaging material migrants
and pesticide residues.'
Great care, therefore, must be exercised in
48. A non-prescription remedy (commonly known as an over-the-counter or "OTC" drug) is
normally chosen because of its advertised or label representations to alleviate a specific
condition, e.g., headache, running nose or dandruff, then bothering the consumer. Under
regulations issued pursuant to the Fair Packaging and Labeling Act, OTC drugs will be required
to bear a prominent and conspicuous statement of either the general pharmacological category
of the product or the product's principal intended actions. 21 C.F.R. § 1.102a(b) (1968). Under
21 U.S.C. § 352(e), the label of the drug must bear the statement of the active ingredients.
49. Drugs requiring medical supervision in their use or that are dangerous if not medically
supervised can be sold to consumers only upon the prescription of a physician, 21
U.S.C. § 353(b) (1964), and in turn the physician is the subject of detailed information required
to be contained in the labeling and advertising of prescription drugs with respect to their safety
and efficacy, see 21 C.F.R. § 1.106 (1968); 21 U.S.C. § 352(n) (1964); 21 C.F.R. § 1.105
(1968). See generally Duggan, Foods and Pesticides, FDA Papers, Sept. 1968, at 14.
50. 21 U.S.C. § 343(i) (1964), requires all of the ingredients to be listed on the label of a
food that is not standardized, 21 U.S.C. § 343(k) (1964), requires a specific declaration of the
presence of artificial coloring, flavoring and chemical preservatives. It is, nonetheless, doubtful
that in choosing prepared foods, many decisions are predicated on the specific presence or
absence of items identified simply as "BHA" or as incomprehensively as "calcium disodium
EDTA." See 21 C.F.R. §§ 121.1035, 121.1017 (1968). In the case of some standardized foods,
there is no requirement that the technical ingredients be listed on the label, e.g.. 21
C.F.R. § 17.1(a)(15) (1968), providing for dough conditioners in standardized white bread.
51. The safety of packaging materials is covered by the Food Additives Amendment, and
regulations have been issued as 21 C.F.R. § 121(F). Pesticide residues on raw agricultural
commodities are controlled under 21 U.S.C. § 346a (1964). The last sentence of 21
1968]
FDA AND PUBLIC INTEREST
determining whether 'a product is suitable for consumption. In the
process of making this determination, FDA not only must subject test
data52 to thorough evaluation, but must also determine whether a
safety level, once established, can be enforced. Both the sensitivity of
testing equipment and the effect that variations in use occurring in
good manufacturing practice can have on the level of the presence of
the additives must be scrutinized. 3 When technology was less
sophisticated, FDA decisions were easier to make. For example, it
could once be said that there were "no residues" of a chemical
present, or that a food was "unblemished." With improvements of
technology,54 however, the possibility of meeting a test of "zero" for
residues became less likely. The agency was forced into the position of
demanding a standard of "zero," or the ininimum quantity of residue
detectable under a given method, which could not be said to be safer
for the consumer than a different standard of "zero" used
previously. 5 The manufacturer was forced to discard food that he
could not say was unsafe, or had a greater quantity of residue present,
simply because, with more refined methods of analysis, the previously
undetectable residue became known. 6
When judgmental quality control was used, it became apparent that
one of the "zero" levels that had been used could reasonably be
adopted as a safe, finite tolerance. Test data and detailed information
on industrial needs and residues could lead to regulations specifying
"negligible" but finite tolerances.
7
The use of judgmental quality
U.S.C. § 343(k) (1964) specifically provides that pesticide chemicals as applied to agricultural
produce are not to be treated as chemical preservatives requiring label declaration.
52. The former rule of thumb that predicated safety judgments on 1/100 of the "no effect
level" shown in animal feeding studies, 21 C.F.R. § 121.5 (1968), has undergone extensive
revision to encompass sophisticated determinations based on microscopic physiological changes,
e.g., Goldenthal, Current Views on Safety Evaluation of Drugs, FDA Papers, May 1968, at 13.
53. All food additives are subject to some tolerance, whether the gefieralized rule of "good
manufacturing practice," 21 C.F.R. § 121.1000(a) (1968), or a much more precise requirement
limiting usage to a specified maximum percentage, often expressed in "parts per million," e.g.,
21 C.F.R. §§ 121.1001, 121.1034-35 (1968). Test methods for many of these tolerances are
extremely complex and sensitive. E.g., 21 C.F.R. § 121.1156(b) (1968), a 42 page description
of the analytical procedure for testing petroleum wax to determine ultraviolet absorbence limits,
and 21 C.F.R. § 121.1214(b), a method sensitive to 25 parts per billion.
54. Improving technology is evident not only in the field of food additives, but in all areas of
enforcement. See, e.g., Freeman, Cod or Crab?, FDA Papers, Sept. 1967, at 19.
55. NAS-NRC Pesticide Residues Committee, Report on "No Residue" and "Zero
Tolerance" (1965); 31 Fed. Reg. 5723 (1966).
56. Id.
57. E.g., the finite tolerances adopted for streptomycin residues on apples, 33 Fed. Reg. 10714
(1968). See generally Duggan, Foods and Pesticides, FDA Papers, Sept. 1968, at 14.
THE AMERICAN UNIVERSITY LA W REVIEW
[Vol. 18
control in this fashion provides the manufacturer with certainty as to
the standards required for his product, and such certainty permits him
to operate his business more economically. The creation of finite
tolerances, or negligible residues, and other terms indicative of the
establishment of specific levels of regulatory acceptance fulfills FDA's
obligation to regulate in the public interest, both with respect to the
consumer and with respect to the manufacturer.
ECONOMIC ASPECTS OF REGULATION
Standardization of Foods
Since each member of society is in some sense a consumer, there is
a wide range of factors to be taken into account in analyzing
consumer needs and preferences. Even when, for the purposes of
simplicity, FDA restricts its analysis to the housewife, the type of
consumer who makes the bulk of food purchasing decisions, the
diversity of socio-economic classes, ethnic backgrounds, ages and sizes
is considerable. Frustration in attempting to identify representative
housewives has caused some to urge the Secretary of Commerce,
under the Fair Packaging and Labeling Act,s to find that there is an
undue proliferation of varieties, thus creating the need for
congressional standardization. Since such action appears unlikely, the
FDA must continue to cope with the problems of consumer variability
in general and the idiosyncrasies of housewives in particular. There is
the housewife who is accustomed to preparing her own food and who
still likes to make her own preserves and pickles; there is the young
housewife who wants to learn to cook but who works and must rely
on convenience foods; there is the housewife who studied home
economics in college; there is the high school graduate with one
course in home economics; and there is the inner-city housewife who
is culturally deprived. Because of this diversity, FDA's responsibility
in the complex area of economic regulation is more difficult to
discharge than its responsibility for the safety of the food supply, and
the problems presented in the standard-setting program provide an
example of the special problems encountered in the field of economic
regulation.
Food standard proceedings are initiated upon a determination that
the issuance of a standard will "promote honesty and fair dealing in
the interest of consumers," 9 the purpose of this provision being to fix
58. Cf., Fair Packaging and Labeling Act 15 U.S.C. §§ 1454(d), (e) (Supp. iii, 1965-67).
59. Section 401, 21 U.S.C. § 341 (1964). The phrase first appeared in the McNary-Mapes
1968]
FDA AND PUBLIC INTEREST
the composition of a food to be identified by a recognized name.60 The
need for such standardization may arise from consumer confusion or
from the threat of product debasement.6 ' The agency is specifically
authorized to exclude wholesome and beneficial ingredients from a
food and confine the food within a recognizable, but reasonable,
definition. 62 Once the definition has been fixed, simple descriptive
labeling attempting to differentiate a similar product containing
ingredients other than those permitted in the standardized food will
generally not suffice to avoid the effect of the definition in prohibiting
nonconforming products.63
Most of the present standards are "recipe" standards-they usually
describe how to make a given food and enumerate all the items that
may or must go into the food. 64 The reasoh for the prevalence of
recipe standards is that they reflect formulas that have been developed
and become accepted over a long period, and since housewives
Amendment to the 1906 Act, which authorized the Secretary to establish such standards for
canned food as would "in his judgment promote honesty and fair dealing in the interest of the
consumer." Pub. L. No. 71-538, 46 Stat. 1019 (1930).
The protection of consumers by fixing baselines against a threat of confusion or economic
debasement also serves the interest of manufacturers, by setting an economic baseline that he
should be confident all his competitors are required to meet when selling a food- under a given
name to the public. One difficulty in food standards has been the failure in some cases to have
precise methods of enforcement, with the result that the consumer is not protected against
debasement and manufacturers who comply with the standard can find themselves at an
economic disadvantage with those who carefully skimp. L. Beacham, Food Standards, FDA
Papers, July-Aug. 1967, at 4, 6; Stephens, Food Standards and the FDA (FDA Mimeo.) May
26, 1964; Austern, Lofty But Reachable-Some Possible Improvements in Food
Standardization, 20 FOOD DRUG Cosm. L.J. 188 (1965).
60. Security Adm'r v. Quaker Oats Co., 318 U.S. 218 (1943); Austern, supra note 22, at 53843.
61. Security Adm'r v. Quaker Oats Co., 318 U.S. 218 (1943); L. Beacham, Food Standards,
FDA Papers, July-Aug.. 1967, at 4; Austern, Current Developments in Food Standard
Proceedings, 4 FOOD DRUG CosM. L.J. 333-36 (1949).
62. Security Adm'r v. Quaker Oats Co., 318 U.S. 218 (1943); Austern, supra note 22, at 54754.
63. Libby, McNeil & Libby v. United States, 148 F.2d 71 (2d Cir. 1945), affg, 55 F. Supp.
725 (E.D.N.Y. 1944). This apparently simple rule was made more complex by the decision of
the Supreme Court in 62 Cases . . . of Jam v. United States, 340 U.S. 593 (1951), where the
Court held that a product labeled "Imitation Jam" did not purport to be and was not
represented as the standardized food "jam," and was labeled properly in conformity with 21
U.S.C. § 343(c) (1954), governing imitation foods. See generally Austern, Ordinary English But
Not Ordinary Jam, 6 FOOD DRUG Cosm. L.J. 909 (1951). A food may be an imitation of
another food even where descriptive labeling is used and in the absence of a standard. United
States v. 651 Cases . . . Chocolate Chil-Zert, 114 F. Supp. 430 (N.D.N.Y. 1953).
64. E.g., 21 C.F.R. §§ 16.1, 16.6, 27.2, 27.30, 29.1 (1968).
THE AMERICAN UNIVERSITY LA W REVIEW
[Vol. 18
customarily made preserves,6" baked bread,66 whipped mayonnaise,"
churned ice cream6" and canned vegetables,69 it was not very difficult
to determine consumer understanding as to the composition of these
foods. However, it is quite difficult to determine consumer
understanding as to fabricated foods, since these have never been
made in the home. Differentiating between consumer expectation as to
performance and consumer expectation as to composition becomes
difficult for such products as carbonated soft drinks," fabricated cake
mixes and peanut butter," since each housewife may have a different
expectation as to the identity of the food, different information
desired about the food, and a different expectation as to what she will
get from the food.
Determining Consumer Understandingand the Consumer Survey
In food standard proceedings, the Food and Drug Administration
very often assumes the role of spokesman for the consumer,
predicating this assumption on its alleged knowledge of consumer
desires and expectations.7 2 Frequently, however, the agency position is
at variance with consumer preferences as demonstrated in the market
place. This information problem is compounded by the fact that many
other groups, in addition to FDA, claim to speak for the consumer,73
creating further uncertainty as to the actual feelings of the public.
Efforts have been made to get the consumer to speak for herself, as
the Federal Register.74 FDA press releases7" and FDA "Memos for
Consumers" 6 regularly solicit consumer views. These efforts have
65. See 21 C.F.R. §§ 29.2-,3 (1968).
66. See21 C.F.R. § 17.1 (1968).
67. See 21 C.F.R. § 25.1 (1968).
68. See 21 C.F.R. § 20.1 (1968).
69. See 21 C.F.R. Part 51 (1968).
70. 21 C.F.R. Part 31 (1968).
71. See Findings 3 and 6, Docket No. FDC-76, 33 Fed. Reg. 10507 (1968).
72. Beacham, supra note 58.
73. In the presently pending hearings on the Special Dietary Food Regulations, two
organizations asserting to represent consumers, and somewhat over a dozen individuals,
appearing simply as consumers, are participating actively.
74. The standard form order invites all interested persons to submit their views and
comments. E.g., 29 Fed. Reg. 15173 (1964).
75. FDA maintains a press office with sections for the general public, specialized publications
and industry.
. 76. FDA's "Memo For Consumers" is but one of a variety of consumer education activities.
There are numerous publications explaining both FDA's activities and in general terms
indicating the protection provided by the various acts FDA enforces. E.g., FDA, Facts for
Consumers: Pesticide Residues, Publication No. 18, Oct. 1963.
19681
FDA AND PUBLIC INTEREST
generally failed, however, and the principle of judgmental quality
control demands that a more effective method of determining
consumer preferences be utilized. Such a method is the statistically
drawn sample based on interviews with consumers, or the consumer
survey." The long-pending peanut butter controversy will be used to
illustrate the proposition."
In the early 1940's, the FDA position was that peanut butter
consisted entirely of ground peanuts, with perhaps a bit of salt or
seasoning." Even then, however, consumers had begun to favor new
processing methods that eliminated oil separation, hardening, and
unsightliness." Because of a lack of judgmental quality control,
FDA was still mired in this technical and cultural lag in the 1960's,
and only a thorough-going public hearing beginning in 1965 on new
developments in peanut butter and consumer preferences helped to
alleviate the problem!"
This hearing could well have closed the information gap sooner had
not FDA ignored the possibility of using scientific survey methods to
determine consumer preference and understanding.
The 1959 proposal to standardize peanut butter, published on the
initiative of FDA, sought consumer views through the traditional
Federal Register notice. 2 Based on the information received-virtually
all of which represented industry comments-an order was published
in 1961, but objections were filed to this order and the entire standard
77. Time and money are, of course, limiting factors. Although the preparation of an extensive
survey seeking to elicit the views of a national sample of consumers may take a year or more
and cost more than $45,000, at least one public opinion research company runs a bi-monthly
national probability sample on a "magazine" basis, i.e., a number of different participants
purchase space in the survey based on the number and complexity of the questions they wish to
pose. Using this vehicle, meaningful responses can be obtained from a statistically sound sample
for a few thousand dollars. See, e.g., 21 C.F.R. § 3.70, where such a survey provided FDA with
information that "the ordinary individual who prefers the true, and more expensive, halibut may
purchase fish labeled as 'Greenland halibut' under the impression'that it is a kind of halibut,
which is not the case."
78. 21 C.F.R. § 46.1, issued in final form on July 24, 1968, subject only to judicial review
initiated by two manufacturers.
79. TC-185, Mar. 15, 1940; V. KLEINFELD & C. DUNN, FEDERAL FOOD, DRUG, AND
CosNtEric Acr 1938-1949 641 (1949).
80. Findings 6, 7, and 9, Docket No. FDC-76, 33 Fed. Reg. 10507 (1968).
81. FDA's original proposal to standardize peanut butter in 1959, 24 Fed. Reg. 5391 (1959),
started a proceeding culminating in a final order on July 24, 1968, following a hearing lasting
for virtually six months and comprising a transcript of nearly 8,000 pages. The order issued is, of
course, still subject to judicial review, which could further test the agency's use of judgmental
quality control in assessing the record.
82. 24 Fed. Reg. 5391 (1959).
THE AMERICAN UNIVERSITY LA W REVIEW
[Vol. 18
was stayed for the stated purpose of a public hearing.83 Instead of
holding a hearing, however, the Food and Drug Administration in
November of 1964, published a second proposal to standardize peanut
butter 4 and issued a press release, 5 a Memo For Consumers, 6 and a
notice in the Federal Register," which ostensibly attracted 2,000
letters commenting on the proposal.8 8 This response could have
constituted a significant sampling of consumers, but when examined
at a public hearing 9 many of these letters proved to be the result of
two radio broadcasts in which the commentator vigorously and
erroneously asserted that peanut butter was being debased with soaps,
detergents, cheap fats, cheap sugar and similar materials.9" The public
response was thus shown to be limited to persons who had been
moved by the radio broadcast to write to FDA, 91 and the person who
makes the effort to express his views in this fashion is hardly typical
of the average consumer. 2
Two broad-based consumer surveys were introduced at the 1964
hearing. One had been conducted by the Agricultural Research
Service of the Department of Agriculture and sought consumer
attitudes concerning the use or rejection of peanut butter. 93 The other
had been conducted on behalf of pea-nut butter manufacturers to
ascertain the public's knowledge of the composition of peanut butter
and its attitude toward formulation changes as against performance
83. 26 Fed. Reg. 11209 (1961), stayed. 27 Fed. Reg. 943 (1962). 21 U.S.C. § 37 1(e)(2)
(1964), provides that a food standard order is stayed by the filing of factual objections to the
order by persons who would be adversely affected should the order go into effect. See Dyestuffs
& Chemicals, Inc. v. Fleming, 271 F.2d 281 (8th Cir. 1959), cert. denied, 362 U.S. 911 (1960);
United States Cane Sugar Ref. Assn. v. McNutt, 138 F.2d 116 (2d Cir. 1943).
84. 29 Fed. Reg. 15173 (1964).
85. HEW-D15, Nov. 14, 1964.
86. CM-32, Nov. 16, 1964.
87. "All interested persons are invited to submit their views in writing," 29 Fed. Reg. 15173
(1964).
88. Exhibit I IA, Docket No. FDC-76.
89. Following the Nov. 1964 proposal, a second final order was issued in July 1965, 30 Fed.
Reg. 8626 (1965), to which objections were filed, resulting in a stay of this order as well, 30 Fed.
Reg. 11349 (1965). A hearing was scheduled, 30 Fed. Reg. 11970 (1965), which commenced on
Nov. 1, 1965, and concluded on Mar. 15, 1966. See 33 Fed. Reg. 10506 (1968) for the complete
chronology.
90. Exhibit 126, Docket No. FDC-76.
91. Testimony of Dr. Walter Woods, Dr. W. Edwards Deming, and Dr. Louise Richards,
Docket No. FDC-76.
92. Dr. Walter Woods, supra note 90.
93. Exhibit 24, Docket No. FDC-76, USDA Agricultural Marketing Service, Marketing
Research Division Report No. 203: Homemakers' Use of and Opinions About Peanuts and Tree
Nuts (1957).
19681
FDA AND PUBLIC INTEREST
characteristics.9 4 The findings issued in this proceeding only
marginally reflect information derived from the surveys, particularly
with respect to the changes in consumer preferences in the style or
physical characteristics of peanut butter without regard for specific
elements of composition. 95
The use of sampling to achieve an understanding of an overall
factual pattern has been used to a limited extent in other areas by the
Food and Drug Administration, particularly in developing the
"market basket," whereby FDA attempts to assess the level of
pesticide in the average diet. 96 FDA has also conducted a number of
surveys in the field bf economic regulation. One, after an initial flurry
of publicity, was passed over as a regulatory tool, 91 another remains
to be tested in a pending proceeding,98 while still others remain in a
regulatory limbo." The agency is presently engaged in the process of
standardizing dietary supplements, vitamin and mineral fortified
foods, and of developing uniform labeling for foods used for weight
control purposes. FDA has stated that it has received 50,000
comments on its original proposals,100 but these comments merely
reflect the opinions of a select group of highly motivated consumers
with special interests.'0 '
94. Exhibit 22, Docket No. FDC-76, Universal Marketing Research, Study of Consumer
Preferences and Expectancies Concerning Peanut Butter (1962).
95. E.g., Findings 3, 7 and 9, 33 Fed. Reg. 10507 (1968).
96. Duggan & Dawson, Pesticides:A Report on Residues in Food, FDA Papers, June 1967, at
4.
97. ARB Surveys, Inc., Public Understanding of Labeling Regarding Oleomargarine,
Cooking Oils and Related Foods, August 1963 (Mimeo.); Press Release HEW-B35 (May 27,
1964). (Both were identified but not admitted into evidence as Exhibits 114 and 114A in Docket
No. FDC-76.)
98. FDA has published food standards for certain dilute juice drinks, requiring as part of the
name of the food a statement based on the percentage of fruit juice in the product, e.g.,
"contains not less than 50 percent orange juice." 21 C.F.R. § 27.120, 33 Fed. Reg. 6865 (1968).
This regulation has been stayed pending a public hearing, 33 Fed. Reg. 10713 (1968), at which
one of the issues will undoubtedly involve a consumer survey that FDA asserts shows "that
many consumers believe the diluted articles contain more orange juice than is actually present."
33 Fed. Reg. 6865 (1968).
99. In the Spring of 1967, FDA solicited proposals for a national study of butter bread, egg
bread, butter-and-egg bread, buttermilk bread and potato bread. FDA Request For Proposal 6755. The use to which the results, FDA, A STUDY OF CONSUMER CONCEPTS AND EXPECTATIONS
CONCERNING SELECTED BREAD PRODUCTS AND THEIR ASSOCIATED
LABEL DECLARATIONS
(1968), will be put cannot now be determined.
100. FDA Press Release (June 17, 1966); FDA Fact Sheet, Special Dietary Regulations, No.
167.
101. Many of the items received were on identical preprinted postcards. One major
organization of consumers having an interest in health foods is a participant in the current
hearings on the Special Dietary Food Regulations.
THE AMERICAN UNIVERSITY LAW REVIEW
[Vol. 18
In addition to their use in the process of standardizing foods,
consumer surveys could be useful in establishing FDA labeling
requirements. It is doubtful whether FDA has tested its labeling
proposals to learn how consumers interpret them and whether the
labels are necessary. Judgmental quality control demands that before
the agency speaks for the consumers on the subject of labeling it
develop objective information about the consumers. A survey
conducted for FDA in September, 1967 was apparently designed to
probe into some of these areas involving vitamins and minerals and
weight control." 2 The results of the survey, however, were not
disclosed at the hearing. Rather, FDA marked as exhibits proposals
made as late as March, 1968 for a National Consumer Survey on the
proposed regulations.' °3 The proposals should have been undertaken
prior to the promulgation of the regulations rather than being
contemplated while a massive public hearing was in progress.
One of the critical factors in the efficacy of the consumer survey, as
in all surveys, is the manner in which the survey question is posed to
the interviewee. For example, if the consumer is asked whether ice
cream should be six percent, eight percent, ten percent, or twelve
percent butterfat, he may well express a preference for a higher
percentage simply because he believes that a greater quantity of a
valuable ingredient will automatically produce a "better" finished
product.0 4 The question can be turned around by asking how much
butterfat there is in ice cream. When the question is posed in this way,
the consumer's response usually reveals a large measure of
ignorance.' 5 But, it is possible to ask the consumer what he is looking
for in ice cream. He could be asked to describe the flavor, the texture,
the grain, the weight, and then asked whether he can find such ice
cream in the store. It is even possible to ask about specific brand
names, although limitations upon size would probably prevent the
102. National Analysis, Inc., A Study of Health Practices and Opinions, Study No. 1-71 IA,
Sept. 1967.
103. Government Exhibits 1803A-03B, FDA Proposal 641-8-114, proposing a consumer
survey in the areas of dietary supplements of vitamins and minerals, vitamin and mineral
fortified foods and foods for special dietary use. There is some evidence that this survey may
now be in progress contemporaneously with the hearings. Food Chemical News, Sept. 2, 1968,
at 20 (report on contract for vitamin and mineral consumer survey to be conducted by Day &
Zimmerman Consulting Service).
104. This result is often simply a reflection of consumer ignorance. Where the fact is well and
widely known, the single known value is the one given.
105. See Exhibit 22, Docket No. FDC-76, where food shoppers were asked what percentage
of peanut butter they thought was peanuts.
1968]
FDA AND PUBLIC INTEREST
accumulation of sufficient brand names in a national sample to
0 6
provide much valuable information.
CONCLUSION
To date the utilization by the Food and Drug Administration of
statistical surveys has been erratic and often ineffectual. One of the
ways to enhance the effectiveness of surveys is for FDA to cooperate
with industry in the effort to elicit information upon which
regulations can be based. Such cooperation would have a financial
benefit for FDA and would serve to ameliorate the friction between
industry and the agency which has heretofore caused valuable data to
be wasted. 107
If fully implemented, statistical sampling, as one element of
judgmental quality control, can be a valuable tool in developing
standards that promote honesty and fair dealing in the interest of
consumers. The consumer survey can determine consumer
expectations, desires and preferences, form the basis for developing
more precise standards of fill,' 0 determine consumer response to "cent-
off" offers0 9 and labeling practices," 0 and can provide a "feed back"
of the effectiveness of existing regulations."' While the spinning of
computer reels cannot displace human judgment, the accumulation
and correlation of data contained on those reels is an indispensable
first step in the formulation of quality decisions.
106. See, e.g., USDA Agricultural Marketing Service, Marketing Research Division, Report
No. 203: Homemakers' Use of and Opinions about Peanuts and Tree Nuts (1957), which
elicited reasons for using and not using peanuts and peanut butter and attitudes with respect to
characteristics of peanuts and peanut butter.
107. Such a situation prevails in the public hearing on peanut butter, where industry criticized
in detail FDA's survey attempts at the manufacturing level, and FDA in turn criticized
industry's attempts at determining consumer attitudes.
108. The standard of fill for canned tuna, 21 C.F.R. § 37.3, was developed on the basis of
sampling, and requires adequate sampling for its operation. The sampling procedure for
standard of fill for canned pineapple, developed at hearings held in 1951 and 1952, was based on
a specific statistically founded sampling procedure designed to take into account natural
variations and good manufacturing practice. To date no final order has been issued in that
proceeding. Standards of fill are provided for by 21 U.S.C. § 341 (1964).
109. Cf., 15 U.S.C. § 1454(c)(2) (Supp. 1II, 1965-67).
110. 15 U.S.C. § 1454(c)(3) (Supp. 111, 1965-67).
Ill. In addition to economic matters such as are found in labeling requirements under food
standards or under the FPLA, the effectiveness of FDA's protection of the public health could
be tested by determining consumer recognition and understanding of warnings for drugs
suggested in 21 C.F.R. Part 131 (1968), or that may be enforced under the New Drug
Provisions of the Act, 21 U.S.C. § 355 (1964).