Nutritional Health Alliance v. Shalala

• Decision Date: 31 January 1997
• Docket Number: No. 95 Civ. 4950 (RO).,95 Civ. 4950 (RO).
• Citation: 953 F.Supp. 526
• Parties: NUTRITIONAL HEALTH ALLIANCE and Soo Man Shim d/b/a New Nutrisserie, Plaintiffs, v. Donna SHALALA, in her official capacity as Secretary, U.S. Dept. of Health and Human Services, and David A. Kessler, Commissioner, Food and Drug Administration, Defendants.
• Court: U.S. District Court — Southern District of New York

Page 526

953 F.Supp. 526

NUTRITIONAL HEALTH ALLIANCE and Soo Man Shim d/b/a New Nutrisserie, Plaintiffs, v. Donna SHALALA, in her official capacity as Secretary, U.S. Dept. of Health and Human Services, and David A. Kessler, Commissioner, Food and Drug Administration, Defendants.

No. 95 Civ. 4950 (RO).

United States District Court, S.D. New York.

January 31, 1997.

Bass & Ullman (Milton A. Bass, Steven Shapiro, of counsel), New York City, for Plaintiffs.

Mary Jo White, United States Attorney for the Southern District of New York (Kay K. Gardiner, of counsel), New York City, for Defendants.

OPINION AND ORDER

OWEN, District Judge.

Americans spend approximately $3.5 billion a year on vitamins and other dietary supplements, with more than 120 million people taking them regularly. Under the current federal regulatory scheme, retailers and manufacturers are prohibited from making any "health claim"¹ or "disease claim" on the labels of these vitamins unless there is a Food and Drug Administration ("FDA") determination that there is "significant scientific agreement" that the claim is valid. Until the mid-1980's there were virtually no health claims on labels because an even stricter standard was in place. In the mid-1980's, however, disease claims, many of them asserted to be unfounded, confusing, and misleading, began appearing on vitamin labels. During the last ten years, Congress, the FDA, the dietary supplement industry, and consumer groups, in an attempt to balance the interests of protecting the public from unsubstantiated health claims on the one hand and maximizing the information available to consumers on the other, have debated whether and under what circumstances to permit these health claims on the labels of vitamins.² In 1990, Congress reached a compromise and passed the Nutritional Labeling and Education Act of 1990 ("NLEA"),³ which in part created the current framework for permitting health claims on dietary supplement labels. Plaintiffs here challenge, on First Amendment grounds, this NLEA framework requiring advanced FDA authorization for health claims made on vitamin labels.

Plaintiff Nutritional Health Alliance is a non-profit association of manufacturers, distributors, and consumers of dietary supplements, and plaintiff Soo Man Shim d/b/a New Nutrisserie is a natural product retailer that also markets a line of dietary supplements. Plaintiffs (collectively "NHA") seek declaratory and injunctive relief, contending that the NLEA and FDA implementing regulations unconstitutionally infringe protected speech. Defendants Donna Shalala, Secretary of the United States Department of Health and Human Services, David Kessler, Commissioner of the FDA, and the United States (collectively "the Government") move to dismiss NHA's complaint under Fed.R.Civ.P. 12(b)(1) and (6) for lack of standing and failure to state a claim for which relief can be granted, respectively. Plaintiffs cross-move for summary judgment.⁴

Recently, the District Court for the District of Utah addressed the central issues here in National Council for Improved Health v. Shalala, 893 F.Supp. 1512 (D.Utah 1995) (hereafter "NCIH"),⁵ and granted the Government's motion to dismiss, finding the framework constitutional. On one issue alone do I disagree.

Under the regulatory scheme now in place, manufacturers submit proposed claims to the FDA for analysis, within the agency's deadlines under 21 C.F.R. § 101.70 (1994) as follows: within 100 days of receiving a petition for a health claim, the FDA must notify the petitioner that the claim is denied or being filed for extensive review; if a claim is filed for such review, within the next 90 days the FDA must either 1) deny the use of the claim, or 2) if it does not deny the claim, publish proposed regulations regarding the claim.⁶ There is, however, thereafter, no deadline whatsoever imposed on the FDA to promulgate final regulations for proposed health claims.⁷ The absence of such a deadline here, I conclude, is in conflict with the First Amendment.

After the promulgation of the dietary supplement final rules in January 1994 — which are at issue in this case — the landscape of dietary supplement regulation changed yet again with the enactment of Dietary Supplement Health and Education Act of 1994 ("DSHEA").⁸ Concern over excessive regulation of dietary supplements and the suppression of truthful information drove the passage of the DSHEA, and the mandates and tone of the DSHEA signal a shift toward a more permissive approach to health claims on labels. For example, the DSHEA announces Congressional findings of fact highlighting the importance of dietary supplements: "[A]lthough the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;" a new "rational Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements...."⁹ Moreover, upon signing the DSHEA, President Clinton noted that

... manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law....

[I]n recent years, the regulatory scheme designed to promote the interests of consumers and a healthful supply of good food has been used instead to complicate choices consumers have made to advance their nutritional and dietary goals. With perhaps the best of intentions agencies of government charged with promoting the food supply and the rights of consumers have paradoxically limited the information to make healthful choices in an area that means a great deal to over 100 million people.¹⁰

The DSHEA explicitly exempts a category of claims from the FDA pre-authorization process, so-called "structure/function" statements (such as "Calcium builds strong bones") which involve the way in which a nutrient affects the function or structure of the body. 21 U.S.C. § 343(r)(6). A structure/function claim is permitted so long as the FDA is notified, the manufacturer has substantiation that the claim is truthful and not misleading, and the product contains a disclaimer.¹¹ Moreover, the DSHEA lays the groundwork for new standards and procedures to replace the FDA pre-approval framework being challenged in this action. These are presently under consideration.

At the threshold, the Government contends that the Court need not reach the merits of the case because plaintiffs do not have standing. However, I find standing, agreeing with the district court's holding in NCIH with respect to this question:

In this case, the plaintiffs' facial challenge of the health claims regulations implicates the First Amendment. Additionally, as was the case in Forsyth, every application of the challenged regulations could impermissibly suppress protected speech. Therefore, in light of the expanded notion of standing under the "overbreadth doctrine," this Court determines that plaintiffs have standing to challenge the health claims regulations.

NCIH, 893 F.Supp. at 1516. I also agree with NCIH, that the speech here is commercial. Id.

I turn, therefore, to the four-prong test established in Central Hudson Gas & Electric Corp. v. Public Serv. Comm'n of New York, 447 U.S. 557, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980), for determining whether particular regulations of commercial speech survive scrutiny under the First Amendment:¹²

(1) Whether the speech is misleading (if it is misleading or unlawful, no further inquiry is needed and the speech may be restricted);

(2) Whether the government's asserted interest in regulating the speech is substantial;

(3) Whether the restraint directly advances the government's interest; and

(4) Whether the legislation is no more extensive than necessary to serve the government's interest.

Id. at 566, 100 S.Ct. at 2351.

The first three Central Hudson prongs require only brief comment. Under the first prong, if the speech is misleading, it can be prohibited. Although the Government argues that health claims that have not been FDA approved are inherently misleading, not all potential health claims are misleading; at least some can be presented in a non-misleading fashion.¹³ Accordingly, like the court in NCIH, I hold that plaintiffs clear this first Central Hudson hurdle. NCIH, 893 F.Supp. at 1516.

The second Central Hudson prong, whether there is a substantial governmental interest, is clearly met in this case. NCIH, 893 F.Supp. at 1518. The legislative history of these provisions reveals that substantial governmental interests drive the NLEA and implementing regulations: preventing the spread of unsubstantiated health claims on labels so that consumers may not be deceived and follow unsound health practices; ensuring the reliability of scientific information disseminated in connection with the sale of dietary supplements; and protecting consumers from being induced to purchase products by misleading information on labels.

The third Central Hudson prong addresses whether the NLEA and FDA regulations directly advance the Government's substantial interests, and as noted in NCIH, the Supreme Court recently articulated the Government's burden: "The government carries the burden of proving the direct and material advancement of its interests.... [The government] seeking to sustain a restriction on commercial speech must demonstrate that the harms it recites are real and that its restrictions will in fact alleviate them to a material degree." NCIH, 893 F.Supp. at 1518. Here too, I agree with the NCIH holding that the Government has shown that the NLEA and FDA regulations directly and materially advance their substantial interests.

It is the fourth Central Hudson prong that requires...