GOVERNMENT REGULATIONS 15

MAN DREAMS: MAN CREATES. He changes his envi-

ronment in search of a better life. In the beginning he
became man when he began to create options beyond
those provided by nature. His hopes for a better tomor-
row challenge him to extend his knowledge.
In the more advanced countries of the free world,
where he has been oriented to the future and open to
change, man has extended his basic freedoms via tech-
nology and the free enterprise system. But he continues
to hope for a still better society, for his children and for
their children, and this can only be brought about by
constantly redirecting and refocusing technology so that
the risks remain subordinate to the benefits.
Technology and society work a complex weave of
effects upon each other. Our society recognizes certain
obvious hazards in unbridled technological progress.
Yet, many of us are unaware that excessive intolerance
to risk will condemn us to a retreat from technology and
then to the lustreless and uncertain future of second-
rate nations. The engines of consumerism, the press,
special interest groups and a somewhat over-responsive
government are leading us away from innovation.
They are stifling technology by legislative fiat and
regulation. The odds for turning aspirations into
achievements grow slimmer every year, as more and
more effort is required for less and less return.
Risk is becoming excessively expensive as intoler-
ance continues to escalate. The costs of product
development, health and safety in the workplace, qual-
ity assurance, product liability and similar risk-related
attributes of marketing are now growing at an overall
rate of some 14% per year. Like all other business costs,
those for risk-management are passed along to the
unsuspecting consumer. Like the government, we are
now spending his money for him, in the name of protec-
tion, reducing his purchasing power through inflation,
and therefore his standard of living. Higher retail costs
then inevitably lead to further attacks on the business
community. Until people realize the dangers of an
over-benevolent society and the risk of risk avoidance,
technological apathy will remain one of our most press-
ing national problems.
An example of added cost without comparable added
value can be cited in the case where a major pharma-
ceutical marketer developed a line of topical products,
including an aerosol dispenser, all based upon a new
European drug. The aerosol product alone required a
pre-marketing program lasting three years, during
which over 38,000 sample units were prepared in the
laboratory for testing purposes. This work was required
to satisfy FDA requirements. The contract filler had to
apply strict Current Good Manufacturing Practices
(CGMP—or, simply, GMP) as stipulated by the FDA,
and this added considerably to his costs. When the
product finally reached the market it sold for over three
times the retail cost of a very similar cosmetic
formulation.
The cost of governmental regulations designed to
reduce perceived or imagined risks is truly awesome:
slightly over $200 billion per year, or about $3,900 per
year during 1980 for an average family of four. In 1979,
these added costs helped give the U.S.A. a 13% infla-
tion rate, a 0% productivity increase and a Real GNP
of -3%, after inflation. In 1980 and 1981 the figures
were quite similar.
Another example of regulatory costs was developed
in a survey on the impact of the EPA's Toxic Substance
Control Act (TSCA) on innovation in the chemical
specialties industry, which includes aerosol products.
The study was conducted in 1981 and predicted a 36 to
67% decline in product and formulation innovation.
The testing rules under Section 4 of TSCA are now in
effect, and the EPA suggests that it will now cost about
$ 1 million per chemical to get their approval to market a
new product. A major marketer has disagreed, stating
that the mandated carcinogenic and other tests will take
over three years and boost the overall cost to $2 million.
Small chemical manufacturers simply cannot afford to
develop new products on this basis. Those that depend
heavily on such projects will either have to realign their
activities or go out of business.
The impact of government upon the aerosol industry
has been touched upon throughout this book. The reac-
tion of the EPA/FDA to the chlorofluorocarbon-ozone
question in 1975 was a major factor leading to a
business reduction of over 30%. The associated bad
press and virtual elimination of television advertising
has kept the industry flat ever since. Conversions to
hydrocarbon propellents cost the industry an estimated
$40 million at a time when severe over-capacity was act-
ing to drive down contract filler prices to the point
where profit margins nearly vanished. About 1979 the
cost of money began to escalate rapidly, moving up to a
prime rate of 21 % in 1981. When a contract filler pur-
chases components and/or chemicals for a customer, his
funds may be tied up for 2.4 months before payment is
received. If he is fortunate enough to have access to
"20% money", his cost of money wll then be 4%. By
way of example, if he purchases $0.95 of materials per
can and pays $0.05 per can in wages and other imme-
diate expenses, then his cost for money will be $0.04 per
can. This would be about 25 to 50% as much as his
unadjusted service income. The net effect has been to
cause fillers to ask marketers to order all materials
except the propellent, and sometimes to offer discounts
to those who can pay at the time of purchase, with
minor deviations then credited or debited, according to
the number of units actually produced, material gains
or losses and so forth.
All of these effects have caused a drastic weakening
of the industry. During 1981, a capacity reduction of
about 170 million units per year occurred, through the
closing of two major plants and the elimination of others
as a result of economics or fire. By early 1982, an addi-
tional 100 million units of capacity was eliminated.
Two or more firms avoided bankruptcy by selling out to
competitors. The attrition is expected to continue at
least through the end of 1983. The strong recessionary
characteristics of 1981 and 1982 have led to heavy bor-
rowing from suppliers and to delayed payment of in-
voices (90 to 150 days) on the part of some fillers. The
future viability of these firms must be regarded as
uncertain.
During the decade of the 1970s, the Congress of the
U.S.A. turned out from 180 to 375 anti-packaging bills
per year. At the start of the 80s this was down con-
siderably. Under "Reaganomics", regulatory activi-
ties were picked up by the states at an unprecedented
rate. During 1981 a total of some 55,000 state bills were
introduced, of which 57% were passed into law. (The
Federal government passed only 9% of their bills.) The
high percentage of enactments at the state level is one of
concern because many are not well considered, good
quality legislation. They are then subject to regulation
developments never anticipated by the law-makers. In
one instance, the California State Air Resources Board
threatened to force the replacement of hydrocarbon
propellents by chlorofluorocarbon propellents on the
basis that the hydrocarbons might react photochem-
ically to produce smog in the Los Angeles basin. The
plan was later withdrawn when industry met with the
California Board late in 1981 and advised them that
their basic premise was subject to several technical
errors.
A number of Federal agencies administer regulations
that affect the aerosol industry directly. They include
the following, as perhaps the most important:
a. The Food and Drug Administration (FDA)
i. The Food, Drug and Cosmetic Act (FDCA)
ii. The Fair Packaging and Labeling Act of
1966 (FPLA)
b. The Environmental Protection Agency (EPA)
i. The Federal Insecticide, Fungicide and
Rodenticide Act of 1947 (FIFRA)
ii. The Clean Air Act of 1977 (CAA)
iii. The Solid Waste Disposal Act of 1978
(SWDA)
iv. The Toxic Substances Control Act of 1972
(TSCA)
v. The Federal Environmental Pest Control
Act (FEPCA)
vi. The Resource Conservation and Recovery
Act (RCRA)
vii. The Clean Water Act
c. The Federal Trade Commission
i. The Fair Packaging and Labeling Act of
1966 (FPLA) for non-FDA products
d. The Consumer Products Safety Commission
(CPSC)
i. The Consumer Products Safety Act of 1972
(CPSA)
The Federal Hazardous Substances Act
of 1961 (FHSA)
The Poison Prevention Packaging Act of
1970 (PPPA)
e. The Occupational Safety and Health Agency
(OSHA)
i. The Occupational Safety and Health Act of
1970 (OSHA)
f. The Department of Transportation (DOT)
g. The U.S. Department of Agriculture (USDA)
h. The National Bureau of Standards — Office of
Weights and Measures (Advisory)
Actually, a total of 55 major regulatory agencies
operate in Washington, D.C. In 1980, they produced
over 77,000 pages of regulations, as promulgated in the
Federal Register. Very few will ever be rescinded or
nullified. A survey taken in 1981 showed that, consider-
ing all levels of government, there are about 79,000
administrative agencies, entities or functionalities,
employing about 15,500,000 people, or about 14% of
the nation's work force. These regulatory units often
work closely with the court system, which also employs
millions of people, even up to the U.S. Supreme Court,
the final earthly arbiter of all legal matters. Unlike the
unfettered competitive free enterprise system envis-
ioned by Adam Smith, these figures show that
Americans actually live in a very highly regulated and
controlled society.
The Food, Drug and Cosmetic Act
The basic FDA Act has been in existence since 1906,
with major amendments provided in 1938, 1962 and
1976 that have acted to increase its scope. About 25%
of all consumer dollars are spent on products regulated
by the agency. Aside from foods, drugs and cosmetics,
the revised act provides coverage for medical devices,
for room deodorizers and disinfectant sprays used in
hospital settings and for aerosol products, where
deliberate consumer mis-use allows them to function as
drugs. An example of this last aspect is found in a recent
FDA investigation of aerosol paints and coatings, used
to achieve psychodelic highs by deliberate deep inhala-
tion of the toluene and/or other solvents.
The most successful aerosol food products are whip-
ped creams and cookware release sprays. Syrups,
honey, mayonnaise and other products have been test
marketed in Sepro cans and are now being looked at in
the new Enviro can, which uses pouch-packed citric
acid solution and sodium bicarbonate to generate COz
propellent pressure, as needed. Facilities that produce
these aerosols must be registered with the FDA as food
plants and are subject to GMP inspections to assure the
agency that good, safe, sanitary and correct production
practices are followed.
The ingredients used in food type aerosols must be
FDA-approved. Additives must appear on the agency's
GRAS (Generally Recognized As Safe) list. Everything
that comes into contact with the food product must also
be acceptable to the FDA, and may include the ele-
ments of the storage, compounding, handling and fill-
ing system, any lubricants used in that system, the
aerosol dispenser components and so forth. For exam-
ple, an FDA investigation developed when a new
plastic, used in an aerosol valve, changed color in con-
tact with the food product. In another case, the FDA
disallowed the continued use of neoprene valve gaskets
containing a trace of a thiazole derivative as a curing
agent after it was identified as a possible carcinogen.
Even though the supplier provided data to show that the
amount of unreacted material that could be gleaned off
the surface of the seat gasket and GK-45 type gasket by
the products was in the order of 10 pp(quad), or a
millionth of a ppm, the agency steadfastly called for its
elimination. This was finally accomplished, but with
considerable difficulty.
Drugs, medicinals and pharmaceutical aerosols are
all controlled by the FDA, against differing standards
and with variable strictness. These products include
vascodilators, vaporizers, dermal fungicides, burn
treatments, antiseptics, oral anesthetics, contraceptive
foams, antiperspirants, sunscreens, and probably such
products as depilatories, breath fresheners, skin
dewrinkling preparations and skin moisturizers. They
amounted to about 12% of the total aerosol volume in
1981. Plants filling these products must have at least a
''Type I" Drug Master File. The FDA will send inter-
ested firms a copy of their Guidelines for Drug Master Files
upon request, describing the regulatory requirements
in terms of paperwork to obtain a DMF Number, the
plant facilities, personnel, product types to be made,
operating procedures and so forth. The time required to
receive a DMF Number is 3 to 6 weeks.
Drugs have been officially defined (in 1938) as arti-
cles intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease in man or other
animals, and articles (other than food) intended to
affect the structure or any function of the body of man
or other animals. In contrast, a cosmetic is an article,
other than soap, that is applied to the human body for
cleansing, beautification, promoting attractiveness or
altering appearance. These two definitions are not
mutually exclusive. For instance, a fluorinated tooth-
paste is both a cosmetic, because it whitens teeth, and a
drug because it prevents tooth decay. A personal
deodorant is simply a cosmetic, but an antiperspirant,
which affects a body function (perspiration) is subject to
regulation by the FDA as an over-the-counter (OTC)
drug. Actually, a personal deodorant and an antiper-
spirant may have the same formulation, with the only
difference being in the label claims.
In the sunscreen area, products labeled for use only
as sunscreens unquestionably fall into the OTC drug
category. As such, they must contain the minimum
recommended amount of sunscreening ingredient (2
mg/ml for a lotion) and claim at least the minimum
recommended sun protection factor (SPF) of two —
indicating a blockage of 50% of the sun's ultraviolet
radiation. Such screening agents must be placed in the
FDA's Category I (safe) by the OTC Panel of FDA on
the basis of tests such as photo-toxicity, the Ames
mutagenicity procedure and so forth. For example, a
popular sunscreen, 2-ethylhexyl p-dimethylaminoben-
zoate, has been placed in Category I for concentrations
between 1.4 to 8.0% in the final product.
As of the beginning of 1982 the FDA had yet to issue
a tentative final monograph as the next step in their
review process of such quasi-drug items as moisturizing
lotions and creams (with or without incidental sun-
screening agents present), lip balms and skin softeners.
The question probably will not be settled for at least five
years as to whether or not they are drugs.
Other issues of coverage are equally provocative.
Soap products have been omitted from FDA control,
but does this also apply to the new liquid soaps that cap-
tured over 7 % of the bar soap market between 1979 and
1982? Or to medicated soaps? About 1972 the agency
strongly limited the use of hexachlorophene, based
upon evidence that it might cause brain damage if high
doses were ingested. Skin cleansing products were
limited to 0.75% unless designed for hospital or
prescription uses. Not more than 0.1% could be used in
cosmetics and then only as a preservative. The germ-
icide was banned for feminine hygiene sprays. The
immediate result of these sanctions was to cause indus-
try to drop this valuable and inexpensive product in
favor of other ingredients. One manufacturer stated
that a 3 % hexachlorophene skin cleanser had a multi-
million unit per year business for over 22 years without
any report of a neurotoxic reaction. But in the panic to
abandon hexachlorophene his words fell upon deaf ears
at both the FDA and industry.
A few skin treatment products fall outside the juris-
diction of the FDA, such as insect repellent sprays and
lotions. In one of these products, claims for the preven-
tion and control of poison plant (urushiol) effects are
made, on the basis of absorption of the active ingredient
by hydrous zirconium (IV) oxide/carbonate, thus giv-
ing it drug overtones. In addition, the FDA banned the
use of zirconium compounds in aerosols about 1972,
after satisfying themselves (but not the industry) that
the use of certain zirconium/aluminum chlorhydrate
glycine complexes in antiperspirants might cause pul-
monary problems. While privately agreeing that the
ban should not relate to zirconium oxide compositions
in an aerosol foam type lotion (which could hardly be
inhaled) the FDA made no move to modify the ban. So
in this product we have the unique situation that, if the
insect repellent were to be removed, thus taking the
product out of the "protective'' jurisdiction of the EPA,
it would become a banned drug product under the
FDA.
There are about 355,000 OTC products on the
U.S.A. market, and the FDA began reviewing them in
1972 to assure their safety, efficacy and proper labeling.
Drug review panels, consisting of government and
industry scientists and consumer representatives, have
been doing this work. Panel recommendations are then
analysed by the FDA's Product Evaluation Division
with certain ones accepted for inclusion in the final
monographs. This huge task has been ongoing since the
1970s and will probably never really come to an end.
For one thing, monographs are not monolithic; they
must be changed as more technology develops. Several
have been delayed until further testing can be
completed.
Aerosol antiperspirants are by far the largest aerosol
OTC drug item. Their future is uncertain, at least to a
slight extent, from both a marketing standpoint and the
position taken by the FDA's OTC Drug Review Panel.
During 1980, OTC Review Chief William Gilbertson
advised the industry that the FDA did not agree with
the industry's assessment that two rather new federal
studies on aluminum clorhydrate aerosol antiperspir-
ants sufficiently established the safety of such products
that they should be given Category I (safe) status.
These studies involved Syrian hamsters, Fisher rats and
Hartley guinea pigs, and indicated that when a lung
burden 100 times that expected in an aerosol antiper-
spirant user is produced in these animals the only
response in the lung is an increase in the number of
alveolar macrophages — precisely the same response
that occurs due to the inhalation of common dust. The
OTC Scientific Advisory Committee on Aerosols
recommended to the FDA that aerosol antiperspirants
be placed in the Review's Category III (more testing
needed). Mr. Gilbert son's panel felt that a two-year
primate inhalation study was needed to determine the
safety of these aerosols. They claimed that monkeys are
a better species as a predictor of toxicity in man.
With monkeys from India and Bengladesh costing
about $1,600 each in late 1980, a 50-plus monkey
study, with special housing and feeding costs, could
easily run into millions of dollars. Industry was natur-
ally reluctant to fund such a study, if there was any
other way to satisfy the agency. While an intense study
program was being conducted by the CTFA, the FDA
placed aerosol antiperspirants in their Category III
(more data needed) classification. As a result of recent
clarifications by the courts, FDA has the power to limit
this period to a year, which in this instance would have
the effect of a delayed ban.
After further meetings with industry, in August,
1981, the FDA withdrew the recommendation for a
primate study, finding that the data submitted already
16
pro vide enough information to satisfy the previous
request for subhuman primate data." Instead, they
told the cosmetics industry that an aerosolized
aluminum chlorhydrate two-year inhalation carcin-
ogenicity study in rats is necessary before it can deter-
mine the safety of the antiperspirant ingredient. The
industry has agreed tentatively and protocols are under
development. Implicit in all of this is that the FDA will
maintain aerosol antiperspirant in what amounts to a
Category III status, provided the industry moves expe-
ditiously to have the additional testing conducted.
Regardless of the results of the study (unless interim
results are astonishingly disappointing) the industry
will have until about mid-1984 to market aerosol anti-
perspirants on the present basis.
The larger significance of the FDA's actions are not
lost on the industry.
The agency could be laying the groundwork for
more exhaustive testing of other food, drug and
cosmetic products that are subject to inhalation by
humans, such as hair sprays and after-bath perfumed
talc sprays. A hazard in the latter instance is that the
present market volume for the talc sprays is in the order
of 18 million units per year, hardly sufficient to justify
the funding level needed for a multi-million dollar
chronic inhalation program. Despite occasional quips
that the FDA would prefer to test only heavy-smoking,
asthmatic monkeys suffering from pulmonary disfunc-
tion, the whole issue of inhalation testing is one of
serious proportions and should not be discounted. It
will be with the industry for a long time. Further infor-
mation on chronic inhalation studies is given in the
Toxicology Chapter.
Current Good Manufacturing Practice (CGMP), or
GMP) regulations are provided in the Code of Federal
Regulations, Title 21, Food and Drugs, Parts 200 to 299,
U.S. Government Printing Office, Washington, D.C.
4-1-79, pp 61-80. They describe the minimum require-
ments that a food and drug must satisfy. Increasingly,
industry is extending these concepts to the production
of cosmetics. In fact, about mid-1977 the industry
launched a " Citizen Petition" to have the FDA take
action to develop CGMP in the manufacture, process-
ing, packing and holding of cosmetic items, advocating
that this language be inserted into the Code of Federal
Regulations, Title 21, Cosmetics, Part 750. In 1982, a
spokesman for the FDA suggested that the agency
might publish cosmetic CGMP as guidelines, and then
see if regulations were in fact needed. During 1980,
there were about 375 FDA inspections of cosmetic pro-
duction establishments, and about 89% were found to
be deficient in one or more major respects. Raw
material and product control practices had the highest
deficiency rates: from 46 to 68% deficient. Major prob-
lems during the past few years have included recalls of
cosmetics with illegal colorants and with microbio-
logical contaminants, including Pseudomonas. Nitro-
samine contamination is another area of investigation.
Recent studies have shown that the average person ab-
sorbs 0.41/ig/day of nitrosamines from cosmetics that
pass through the skin and enter the bloodstream, com-
pared with 17.00 /ig/day from one pack of cigarettes.
Cured meats are rated below 0.25 /ig per serving. The
nitrosamine problem with cosmetics may, therefore, be
much less critical than it was once thought to be.
In the future, contract fillers able to demonstrate a
high level of compliance with CGMP will be awarded
more business by increasingly quality conscious
marketers. After the initial investment is made in bring-
ing the facility into compliance, the tight control of yield
accounting, virtual elimination of compounding errors,
customer rejections and field recalls, plus a group of
other advantages will make the operation more com-
petitive than before. One fairly large cosmetic marketer
rates fillers as to plant quality, quality control, quality
assurance, warehouse management, production flex-
ibility, predicted relationships and reputation. Many of
these attributes have strong CGMP overtones. Plant
cleanliness is extremely important, extending even to
the immediate grounds. Good lighting, ventilation and
screening are required. All reasonable measures must
be taken to prevent contamination of chemicals, com-
ponents and finished product by microorganisms,
insects, filth or other extraneous material. Partitions,
roped-off areas, separate enclosures or other divisions
must be used to prevent cross-contamination, the use of
incorrect materials (as from the previous product on a
line), or the erroneous shipment of on-hold or quaran-
tined stock into the distribution system. Each chemical
and component should be traceable by a trail of paper-
work from the time it enters the plant until it leaves,
either as finished stock or as rejected material. Yield
accounting is important as a means of proving lack of
contamination. Every chemical should be analysed
upon receipt. Upon approval the initial hold-tag is
replaced with one that signifies "Approved For Use"
(or a comparable statement) and the lot is transferred to
the "Approved Chemicals" area. Batches and finished
product are handled similarly. It is impractical to try
and provide any more comprehensive treatment of
CGMP requirements in these pages, except to restate
that a very complete set of records must be kept cover-
ing all aspects of the operation. These must include the
signed and countersigned results of all analytical and
microbiological tests, batch preparations, filling
machine operations and other manufacturing records.
When an FDA inspector (or a customer's inspection
team) audits the facility, from one to three days is
required. About 70% or more of that period is spent in
answering questions with frequent references to written
records.
The label of food, drug and cosmetic products must
carry the ingredients, listed in descending order of con-
centration by weight, except that the items present
under 1 % may be scrambled if desired. For foods, in
many instances standards of identity must be met. For
example, if the product is described as honey, that
ingredient cannot be legally diluted with water. A
limited number of propellents are available for foods,
but they include n-butane, isobutane, propane, carbon
dioxide, nitrous oxide, nitrogen and Freon FP C318
(perfluorocyclobutane). In the case of drug products,
the declaration of ingredients must start with the state-
ment "Active Ingredient'', followed by the one or more
items, such as aluminum chlorhydrate, that fit that
description. This is then followed by the statement
"Inert Ingredients'' or "Inerts", after which the re-
maining cosmetic type chemicals are listed. In the case
of cosmetics, a simple listing is all that is needed. The
terminology to be used can be obtained from a book
published by the Cosmetics, Toiletries and Fragrances
Association (CTFA), which is frequently updated by
means of supplements and new editions. The names of
chemicals used in the product should conform to the
sometimes strange designations in the book, since this
provides uniformity and ready reference by poison con-
trol centers and other interested persons, (including
competitors.) No more material should be used in this
declaration than mandated. For example, if SD Alcohol
40 is sufficient, one should not set down SDAlcohol 40-2,
since this is both slightly confusing and may limit a
firm's options for changing denaturants.
New cosmetic ingredients are usually evaluated by
the Expert Panel of the Cosmetic Ingredient Review
Committee (CIR), with their results published as sup-
plements to the Journal of Environmental Pathology and Tox-
icology, starting in May, 1980. The panel examines
existing cosmetic materials as well, particularly those
where scientific reports have indicated a clinical prob-
lem area. For example, work in 1980 implicated
hydroxyanisole as a potential skin depigmenting agent
and this could lead the panel to the conclusion that it is
unsafe as a cosmetic ingredient. In another case, the
clinical data for cetearyl octanoate was insufficient for
the panel to draw any conclusions. In such instances,
industry generally has 90 days to inform the panel that
such studies will be undertaken and completed within
one year. Otherwise delisting follows.
Drug and cosmetic items must be labeled in accord-
ance with FDA regulations. The principal display panel
must be large enough to accommodate all the man-
datory label information without crowding or affecting
clarity. The identification of the product must appear,
in terms of the common or usual name of the product,
as an appropriately descriptive name or as an appro-
priate illustration, illustrating the intended use. The
statement of the identity of the product must be in bold
type, of a size reasonably related to the most prominent
other printed matter on the panel. The name and place
of business of the manufacturer, packer or distributor
must also appear on the principal display panel.
The net contents declaration must appear on the
principal panel, within the bottom 30%, and
reasonably separated and distinct from other live
matter. However, if the package has a label where the
principal display panel is 5 square inches (32.26 cm2),
the 30% requirement no longer applies. If the cosmetic
or drug is marketed using an outer and inner container,
the net weight need not appear on the inner pack.
(Most marketers place a net weight declaration on
both.) The statement of ingredients also need not
appear on the inner pack.
For cosmetics packaged in "boudoir type" con-
tainers, such as decorative cartridges, pencil shapes and
highly stylized glass aerosols, the requirements for the
main display panel are modified to permit this data to
be inscribed on a removable tag or tape, affixed to the
dispenser. In some cases, a small round label is
attached to the base of the container, giving the product
name, manufacturer's name and address, and gener-
ally the net weight. In addition, the manufacturing
code is imprinted on this label, or on the container base
next to it, if there is room.
Aerosol foods, drugs and cosmetics must be labeled
according to their deliverable net weight, in accordance
with regulations under the Fair Packaging and Label-
ing Act (FPLA). If the net weight is less than one
pound, labeling shall be in terms of ounces, such as
"Net Wt 3 oz.". But if the aerosol weight is over one
pound (but less than four pounds), the declaration must
be given in ounces, but followed in parentheses by a
declaration in whole pounds, with any remainder in
terms of either ounces or decimal fractions of the
pound; for instance, "Net Wt 181X2 oz. (1 Ib 2K 2 oz.)"
or "Net Wt 20 oz. (1.25 Ib)". Supplementary state-
ments may include a declaration in terms of fluid
ounces, or one in metric units such as grams, but not on
the principal panel and not in any way that might
hinder the consumer from making proper value
comparisons.
For over a decade several products in the institutional
hair spray category, packaged in large 211x713
(65 x 198 mm) cans, used the declaration of "Net Con-
tents 20 fl. oz. (1 pint 4 fl. oz.)" as the principal indica-
tion of quantity. The "Net Wt 16 oz. (1 Ib)" statement
was subsidiary. The unspoken rationale for using the
volumetric declaration was simply that it provided a
larger number, due to the rather low density of the
product. At one time during the mid to late 1970s the
FDA supported this declaration, based upon a rather
old ruling in the area. But after listening to informal
petitions for uniformity by the National Bureau of
Standards (NBS) and the Interagency Regulatory
Liaison Group (IRLG), FDA attorneys finally decided
to support the net weight concept. A still further delay
period ensued, since the states are the ones with author-
ity to stipulate fill quantities and provide enforcement
actions. Several states, such as Illinois, have suggested
no great preference for one mode or the other. In 1982
these particular products have persisted with the
volumetric declaration.
The size of the net weight declaration is consistant
with FPLA standards. The principal label is defined as
representing the front 40% of the total labeling area of a
container. Where this area is less than 5 sq. in. (32.26
cm2) the label size may be as small as 1/16 " (1.59 mm)
in height. Such containers include glass and aluminum
aerosols up to about a 2 Av. oz. filling weight. For
dispensers with principal panels having an area of
between 5 and 25 sq. in. (32.26 to 161.30 cm2) the label
size must be at least 1/8" (3.18 mm) in height. This
range includes every U.S.A. common aerosol can,
except the 300 x 709 (76 x 192 mm) size, which is
almost never used for FDA products.
According to the FDA, there are about 85,000
establishments in the U.S.A. that are under its
regulatory veil. For the 1980-81 fiscal year, FDA was
granted a budget of $362.5 million, and in 1978 (the
year for which the latest statistics are available) the
agency conducted 34,493 establishment inspections,
conducted 829 product recalls, 385 surveys, 50 inspec-
tion actions and 35 criminal prosecutions. Only about
1.1% of these inspections involved cosmetics plants.
Drug-producing plants were visited frequently, and
food establishments (including markets, restaurants
and grain barges) were visited most of all. The FDA can
be expected to become significantly more important to
the aerosol industry in the future, as a result of CGMP
requirements and their many other activities.
Fair Packaging and Labeling Act of 1966
This is a very narrow and specific act, based on the
premise that informed consumers are essential to the
fair and efficient functioning of a free market economy.
Package labeling labels should enable customers to
obtain accurate information as to the quantity of the
contents and should facilitate value comparisons. The
Federal Trade Commission (FTC) has primary juris-
diction over this act, and through issued regulations
and interpretations, has established labeling guidelines
for consumer products with the exception of foods,
drugs, devices and cosmetics. The FDA has concurrent
jurisdiction to enforce this act with respect to foods,
drugs, devices and cosmetics. The act is straight-
forward and specific on such factors as type sizes, as
indicated in the previous few paragraphs.
The act requires the conspicuous statement of the
name and place of business of the manufacturer,
packager or distributor. Where the product is not
manufactured by the company whose name appears on
the label, the name must then be qualified by a phrase
that reveals the connection such company has to the
product. Such phrases as "Manufactured f o r . . . " ,
"Distributed b y . . . " or "Sold b y . . . " are used to
report the existing relationship. The most appropriate
of these is "Distributed by. . . ".
Various label claims, such as "Cents Off" and
"Economy Size" statements, are controlled by the
FPLA. Deceptive phrases like "Jumbo", "Giant" and
so forth are prohibited. Non-functional oversize
packaging, which may give an aerosol product more
shelf space and make it look larger to the customer, may
be prohibited under the FPLA for cause. Shadow-
boxes, for instance, are permitted, since the actual con-
tainer can be seen. The box provides space for various
information of consumer value and makes smaller aero-
sols less likely to be stolen by shoplifters. Under the act,
questionable, suggestive, improprietous or misleading
names are prohibited.
One of the later provisions of the FPLA is designed to
control savings representation abuses, such as certain
"cents off" and related promotions. The act requires
the retailer to maintain selling price records for a
minimum of one year on any item which has been the
subject of price or other promotions. Inspectors from
the FTC or FDA can then determine if the consumer
has, in fact, been given the savings claimed by the store.
Packages described as "Economy Size" must show a
significant reduction in price per unit of weight; usually
at least 5%. A newly developed commodity, or one
which has changed in some functionally significant
respect, or one that has been newly introduced into a
geographic trade area, may be the subject of an "Intro-
ductory Offer" type promotion. Such packages may be
sold at reduced prices for up to six months, provided
they are labeled as "Introductory Offer" merchandise,
with the post-promotional price included on the label.
The act also concerns itself with several aspects of
overpackaging, operating on the concept that excessive
or blatantly superior packaging may limit the consumer
in making accurate value comparisons. For example,
 internal fillers that are non-functional but serve only to
aggrandise package size are prohibited. Any such fillers
must be shown to be necessary to protect the fragile
inner product. Glass aerosols are sometimes sold in
pasteboard boxes lined with a light corrugate filler, and
this is acceptable to the FDA.
One of the more pertinent aspects of the act with
respect to aerosols is the consideration of non-functional
slack fill. The most common fill for aerosols is about
0 0
85v%, measured at about 7O F (21.1 C). But some
packs are below this level, usually for specific reasons.
Many whipped cream products are packed at about 45
v% of can capacity, because they can carry only a very
low percentage of CC>2 or №0 before pressures in the
can become excessive. The larger head space provides a
larger reserve of propellent gas and prevents the foam
from becoming soupy near the end of the can.
With the change-over to hydrocarbon gases as
replacements for the chlorofluorocarbon propellents,
most problems of non-functional slack fill have been
eliminated. Marketers have been concerned about the
low densities of hydrocarbon-based products and want
to fill cans to the highest practical level to prevent con-
sumer resistance to buying products that seem to be
only half-full or so, on the basis of gross weight.
However, there are still infractions of the spirit of the
FPLA. One major product used to be formulated with
over 90% chlorofluorocarbon propellent and was
packed at the level of 12 Av. oz. (340 g) per 211 x 413
(65 x 122 mm) can. Great difficulty was experienced in
the transition away from CFCs, about 1978, and the
product is now sold as a 4 Av. oz. (113.4 g) fill in the
same can size. The can is about 33 % full, by volume, at
7O0F (21.10C). Because of the unavoidable concentra-
tion of the active ingredient, the product still lasts about
as long as the earlier CFC type dispenser. The formula-
tion is more costly, on a per ounce (or per gram) basis.
Because of these mitigating factors, the company feels
its commitment to business ethics has been preserved.
In the U.S.A. (unlike Europe) there has been almost no
interest or activity in the fill volume of aerosol products.
This includes the non-functional slack-fill area.
The Environmental Protection Agency (EPA)
The EPA is structurally an independent administra-
tive agency which has charge of several acts and statutes
and has a staff which is often augmented by state
government parallel agencies such as for the enforce-
ment of clean air standards. During the Carter admin-
istration, while the budgets of most regulatory agencies
were reduced, the budget for EPA alone was increased
by 40% and some 1,300 staff positions were added. In a
recent CSMA survey, it was found that the EPA had by
far the greatest effect upon the aerosol industry of any
government agency or commission.
Now, under the Reagan administration, there is a
hue and cry that the EPA is about to be destroyed as an
effective agency, due to proposed budget reductions.
The budgets for fiscal years, including construction
grants, amounted to $4.7 billion in 1981 and $5.1
billion in 1982 under Reagan, but were changed to $3.7
billion for 1981 and either $3.4 or $3.75 billion for 1982
(not yet settled) under Carter. The request by current
EPA Administrator Anne Gorsuch for fiscal 1983 is
$3.5 billion. According to Gorsuch, much of the reduc-
tion can be justified in terms of eliminating unproduc-
tive managers and refocusing enforcement and research
toward more productive areas. Persons such as past
administrator Russell Train (1973 - 1977) point to the
difference of up to $1.7 billion in the 1982 budgets and
suggest that this represents a 45% cut when inflation is
considered, and that attrition of personnel is currently
running at 32 % per year. It is too early to determine the
effect upon industry of these sweeping changes. How-
ever, we do recognize that even under the halcyon days
of Carterism, the EPA inefficiencies, lack of decision-
making, delays and other problems were well known to
industry. For example, the registration of a routine
aerosol pesticide could easily take over two years.
The Federal Insecticide, Fungicide and Rodenticide
Act of 1947
This act, labeled with the acronym of FIFRA, was
created for purposes of regulating the marketing of
economic poisons and devices for using them. Up to
1970, the act was administered by the U.S. Depart-
ment of Agriculture (USDA), but then it was trans-
ferred to the newly created Environmental Protection
Agency (EPA), where it remains today (1982). With
regard to aerosol products, the act covers all insec-
ticides, insect repellents, disinfectants, disinfectant
cleaners, fungicidal sprays and weed killers. It does not
include germicides or fungicides designed to be sprayed
on humans or animals. These fall to the FDA. Among
the strange products to be included under FIFRA we
have a tree-banding spray, which places a barrier of
perpetually sticky polybutene/castor wax around a tree
so that various insects cannot crawl up the trunk and eat
the leaves or do other damage. The product was recog-
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