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  September 12, 2002                                

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| Dockets Management Branch                                             |
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| Food and Drug Administration                                          |
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| 5630 Fishers Lane, Room 1061                                          |
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| Rockville, MD 20852                                                   |
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> Re: Constitutional Validity of the Food and Drug Administration's
> Regulations, Guidances, Policies, and Practices in Light of Recent
> First Amendment Case [Law, Docket No. 02N-0209 (67 Fed. Reg.
> 3492)]{.underline}

Dear Sir or Madam:

This response is being filed on behalf of the Point of Purchase
Advertising International in reply to the Food and Drug Administration's
("FDA's") request for comments on whether FDA's regulatory approaches
are constitutional in light of the recent First Amendment case law such
as [Thompson v. Western States Medical Center]{.underline}[^1] affirming
that unnecessary restrictions on commercial speech violate the First
Amendment.[^2]

### About POPAI

The Point of Purchase Advertising International ("POPAI") is the only
trade association of the point of purchase advertising industry and is
dedicated to serving its more than 1,700 members by promoting,
protecting and advancing industry interests

through research, education, industry forums, and public policy
advocacy. POPAI has been for many years a member of the Freedom to
Advertise Coalition and fully supports the comments filed in this
proceeding on behalf of that Coalition.

Because of POPAI's involvement in the creation and distribution of
in-store advertising of a variety of products subject to FDA regulation,
POPAI will utilize the opportunity afforded by FDA's Notice to point out
an apparent misclassification by FDA that may have significant
marketplace implications.

### Full Line Merchandisers Misidentified by FDA

In 1995 when FDA attempted to exert jurisdiction over tobacco, POPAI was
one of the groups which filed suit against the Agency. After extensive
litigation, that issue was finally resolved when the U.S. Supreme
Court[^3] held that FDA has no jurisdiction over tobacco.

POPAI believes the Court's holding on this point was accurate and is
well aware of the tobacco control arrangements set in force by the
Master Settlement Agreement between attorneys general of the several
states and tobacco companies. POPAI agrees that preventing youth access
to tobacco is good public health policy and fully supports those efforts
which have created the age of purchase requirements which are in effect
in every state. Furthermore, the "Synar amendment" mandates that all 50
states vigorously enforce laws requiring retailers to check purchasers'
identification to prevent sales of tobacco to minors. In this way,
tobacco sales to underage consumers can be prevented. This technique
when implemented across the board, can control access.

The FDA proposal. 21 C.F.R. §897.16c would have banned what were
referred to as "self-service displays." The Agency considered these to
be "impersonal modes of sale" along with vending machines and mail order
sales. The POPAI industry identifies these displays as full-line
merchandisers (FLMs) because while they display the product for viewing
by the consumer, the purchase can only be completed when the consumer
hands the product to a sales person and pays for it. FLMs are used for
many products subject to the jurisdiction of the Food and Drug
Administration including OTC drugs, food, and cosmetics. POPAI's concern
is that FDA's mistaken referral to full line merchandisers as providing
access to products in the context of the tobacco proposal could possibly
change the way this medium has long been perceived in the advertising
world by consumers and even by regulators. Clearly, First Amendment
jurisprudence teaches that product displays constitute advertising and
are therefore within the protection conferred by the First Amendment on
commercial speech. Calling FLM's access providers and not advertising
could cause FLMs to be denied the protection clearly afforded by the
First Amendment. [See,]{.underline} e.g., [Carey v. Population Services
International]{.underline}, 431 U.S. 678-700 (1977 "the prohibition of
an advertisement or display of contraceptives is unconstitutional.") [44
Liquor Mart v. Rhode Island]{.underline}, 116 S. Ct. 1495, 1508, (1996)
("Thus, even a communication that does no more than propose a commercial
transaction is entitled to the coverage of the First Amendment").

Indeed, FLMs are considered in the industry as powerful tools for
advertising and promotion.[^4] FLMs are especially potent instruments
for product differentiation because "so many product and brand choice
decisions are made while the consumer is in the store rather than before
he or she arrives at the store. Point of purchase materials play a role,
perhaps the major role, in influencing unplanned purchasing. [^5]

Accordingly, POPAI respectfully requests FDA to utilize this forum to
clarify the status of FLMs as advertising and thus subject to the
protections afforded by the First Amendment to commercial speech. By so
doing, FDA will demonstrate its understanding of this advertising medium
and align its treatment of it with that of the Federal Trade Commission.

We hope these comments are useful to FDA. POPAI will continue its
involvement in this proceeding and in its advocacy of free speech rights
for advertisers.

> Sincerely yours,
>
> POPAI

PSF/kaa

[^1]: Thompson v. Western States Med Center, 122 Supreme Court 1497
    (2002)

[^2]: FDA's notice; Request for Comments, 67 Fed Reg. 3492 (May 16,
    2002); 67 Fed. Reg. 45742 (July 10, 2002, extending the deadline for
    comments)

[^3]: 529 US 120 (2000)

[^4]: [The Power of Point of Purchase Advertising]{.underline}, B. Menin
    & A. Benning 1992, 4T. Shimp also *Promotion Management and
    Marketing Communications* p. 474.

[^5]: Ibid. page 474.