1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction?
September 13, 2002
Dockets Management Branch (HFA - 305)
Food and Drug Administration
5630 Fishers Lane Room 1061
Rockville, MD 20852
Re: Docket No. 02N-0209; Request for Comment on First Amendment Issues
The American Feed Industry Association (AFIA) is the national not-for-profit organization devoted exclusively to representing the business, legislative and regulatory interests of the animal feed and pet food industries and their suppliers. Over 600 companies are members of AFIA, representing nearly 75 percent of the commercial feed and pet food sold annually in the United States. AFIA’s members include manufacturers, ingredient suppliers, animal health companies, equipment manufacturers, large integrated livestock and poultry producers, and firms providing other goods and services to the commercial animal food industry. AFIA appreciates the opportunity to offer these comments on behalf it its members.
AFIA believes the Food and Drug Administration (FDA) violates the First Amendment by prohibiting the flow of health information about animal feed and feed ingredients. Only animal products subject to an FDA-approved New Animal Drug Application (NADA) or an Abbreviated New Animal Drug Application (ANADA) may make health claims and claims of nutritional support. Animal feed manufacturers and animal feed ingredient suppliers risk FDA enforcement action if they make truthful, non-misleading, claims about the healthful qualities of their animal feed products without first obtaining FDA approval.
AFIA urges FDA to examine its unconstitutional regulation of animal feed. Unlike foods and dietary supplements for human consumption, there is no mechanism short of a lengthy pre-approval process for animal feed manufacturers and ingredient suppliers to disseminate health information about the foods animals consume. The Nutrition Labeling and Education Act (NLEA), which authorized health and nutrient content claims for human foods, does not apply to animal foods. The Dietary Supplement Health and Education Act (DSHEA), which authorized various claims of nutritional support for human dietary supplements, has been interpreted so that it does not apply to animal supplements. As discussed in greater detail below, AFIA urges FDA to remedy these unconstitutional and inequitable requirements the agency imposes upon animal feed manufacturers and ingredient suppliers.
FDA’S PRE-APPROVAL REQUIREMENTS FOR ALL ANIMAL FEED HEALTH AND NUTRITIONAL SUPPORT CLAIMS VIOLATE THE FIRST AMENDMENT
FDA’s Pre-Approval Of Animal Feed And Feed Ingredient Health Information
Animal foods must be safe and wholesome for the animals that consume them. Equally important, feed ingredients must also be safe and wholesome for the humans who consume food products of animal origin.
In many respects, the regulation of human foods and drugs is very similar to that applicable to animal foods and drugs. An animal food or supplement is misbranded and an unlawful, unapproved drug if the product’s label or labeling claims the product or its ingredients cures, treats, or prevents a disease or health related condition. 21 U.S.C. § 321(g); § 352(f). Like human drugs, sponsors wishing to market a therapeutic agent for animals for the treatment or prevention of disease usually must obtain FDA’s approval, in the form of an NADA or, for a generic animal drug, an ANADA. Compare 21 U.S.C. § 355 (drug approval process for human drugs) and 21 U.S.C. § 360b (drug approval process for animal drugs). Animal drugs generally are subject to the pre-approval processes of an NADA or ANADA, regardless of the drug’s prescription or over-the-counter status, ingredient, labeling, and condition they are intended to cure, treat, or prevent.
Dietary supplements may make claims of “nutritional support” that are distinct from the pre-approval requirements applicable to drugs and drug claims. A dietary supplement for example, may describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body (“Vitamins A and D are important to strong bones and teeth”) and may characterize the mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function (“Glucosamine supports healthy joint function”). 21 U.S.C. § 343(r)(6)(A). However, FDA has interpreted the DSHEA as allowing only dietary supplements intended for human use to make claims of nutritional support. An animal food in the form of a dietary supplement would be an unapproved and unlawful new drug if it made such claims.
In addition to FDA regulation, animal food manufacturers and ingredient suppliers must also contend with a patchwork of additional and often very extensive State law requirements. Some States will only permit claims on animal food labels and labeling if FDA has pre-approved the claim. Some States go further than FDA and require that animal feed manufacturers and ingredient suppliers submit labels to State officials for approval and clearance. Frequently States rely upon Model Bill and Regulations of the Association of American Feed Control Officials (AAFCO).
FDA’s Pre-Approval Requirements Unconstitutionally Limit The Flow Of Health Information About Animal Feed And Feed Ingredients
There are many animal feed-related products and supplements, including basic vitamin, mineral, and nutrient, and botanical supplements, components of milk replacers, microbial agents, and enzymes for which researchers have documented health benefits in animals. These health benefits include:
· Increased milk production
· Increased protein
· Increased absorption of nutrients
· Support of healthy digestion
· Production of certain antimicrobial compounds
· Control of certain pathogens
· Support of healthy immune response
· Reduction in odors and odor control
· Reduction of ammonia
· Improved bone density
· Improved gum health, decreased tartar, and prevention of gum disease and bad breath
· Improved coat
· Supports hoof health
· Improved muscle tone
· Supports eye health, including reduction in eye tearing
· Supports teat health
· Supports joint health
These health benefits have been reported in peer-reviewed journals. The research further documents that animals, and often humans, have safely consumed these foods, ingredients, and supplements. Yet, even if it possesses sound data demonstrating that an animal food or supplement provides these or other benefits to an animal, a feed manufacturer or ingredient supplier may not make the claim unless the company holds an approved NADA.
FDA’s prohibitions upon animal feed products bearing truthful, substantiated, but unapproved, health and nutritional support claims should be evaluated under the commercial speech doctrine. See Pearson v. Shalala, 164 F.3d 650, 655 (D.C. Cir. 1999), citing Bolger v. Youngs Drug Prods. Corp., 463 U.S. 60, 67-68 (1983). Pearson is especially applicable to the quandary of animal feed manufacturers and ingredient suppliers. In Pearson, FDA argued that health claims for dietary supplements that lack “significant scientific agreement” were inherently misleading and thus entirely outside the protection of the First Amendment. Such claims, FDA asserted, “have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale.” Pearson, 164 F.3d at 655 (emphasis in original). The D.C. Circuit responded, “We think this contention is almost frivolous.” Id. “It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled.” Id. See also Peel v. Attorney Registration and Disciplinary Comm’n of Illinois, 496 U.S. 91, 105 (1990) (rejecting paternalistic assumption that the recipients of a letterhead are “no more discriminating than the audience for children's television”).
Pearson applies with equal force to the truthful, substantiated, but unapproved, health claims and claims nutritional support on animal feed labels and labeling. In Pearson, the challenged health claims at issue were subject to a lesser standard of “significant scientific agreement,” not the more exacting standards of safety and efficacy that must be demonstrated through full reports of clinical investigations necessary for a new human or new animal drug application approval. 21 U.S.C. § 355(b)(1); § 360b(b)(1). If human health claims that do not meet the standard of “significant scientific agreement” are not inherently misleading, neither are animal health claims that have not been subjected to the standards of an NADA approval.
As they are not inherently misleading, under Pearson, it must then be considered whether health and nutritional support claims on animal food are potentially misleading. Pearson, 164 F.3d at 655-56. FDA may not place “an absolute prohibition on ... potentially misleading information ... if the information also may be presented in a way that is not deceptive.” Id., quoting In re R. M. J. , 455 U.S. 191, 203 (1982).
A government scheme to regulate potentially misleading commercial speech is evaluated under the test enunciated in Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n of New York, 447 U.S. 557 (1980). The Supreme Court recently reaffirmed that analysis in Thompson v. Western States Medical Center, 122 S. Ct. 1497 (2002).
Under Central Hudson, and as described in Pearson, a court will look to whether the asserted government interest in suppressing the commercial speech is substantial. Western States, 122 S. Ct. at 1504; Central Hudson, 447 U.S. at 566; Pearson, 164 F.3d at 655-56. It may be presumed that FDA’s interest in protecting public health and animal health is a substantial one that may justify restrictions upon commercial speech of animal feed sponsor. See, e.g., Pearson, 164 F.3d at 656. However, it cannot reasonably be asserted that FDA’s interest in animal health and the safety of those who consume feed animals is any greater than the government interest in consumers who ingest the foods and supplements. The government interest in human foods is not so overwhelming as to ban all human food health claims and claims of nutritional support. See, e.g., Pearson, 164 F.3d at 653; 21 U.S.C. §343(r); 21 C.F.R. Part 101, Subpart E. the government interest in animal health and consumption of feed animals cannot justify a total ban either.
FDA’s requirements that it pre-approve all health and nutritional claims for animal feeds and supplements do not meet the remaining requirements of Central Hudson. FDA’s prohibitions must directly advance the governmental interest asserted, Central Hudson, 447 U.S. at 566, and the restrictions must not be more extensive than is necessary to advance that interest. Western States, 122 S. Ct. at 1504; Central Hudson, 447 U.S. at 566.
The D.C. Circuit rejected FDA’s argument that outright prohibitions upon safe products making truthful, qualified health claims directly advanced the government interest in protecting consumer health:
[T]he government's underlying--if unarticulated--premise must be that consumers have a limited amount of either attention or dollars that could be devoted to pursuing health through nutrition, and therefore products that are not indisputably health enhancing should be discouraged as threatening to crowd out more worthy expenditures. We are rather dubious that this simplistic view of human nature or market behavior is sound, but, in any event, it surely cannot be said that this notion--which the government does not even dare openly to set forth--is a direct pursuit of consumer health; it would seem a rather indirect route, to say the least.
Pearson, 164 F.3d at 656.
As in Pearson, FDA’s interest in protecting public and animal health is not directly advanced by prohibiting truthful, substantiated health information about safe animal feed products. “We view as dubious any justification that is based on the benefits of public ignorance.” Pearson, 164 F.3d at 656, quoting Bates v. State Bar of Arizona, 433 U.S. 350, 375 (1977). “The First Amendment directs us to be especially skeptical of regulations [of indisputably non-misleading information] that seek to keep people in the dark for what the government perceives to be their own good.” Id., quoting 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996) (opinion of Stevens, J., joined by Kennedy, J., and Ginsburg, J.).
FDA’s outright prohibitions upon truthful, substantiated, but unapproved animal food health and nutritional claims especially falter when evaluated under the final prong of the Central Hudson test. The FDA’s prohibitions are far more extensive than are necessary to protect animal and consumer health.
The Pearson court emphasized that the protections afforded commercial speech incorporate a preference for disclosure over outright suppression. Pearson, 164 F.3d at 657. Disclaimers that limit the breadth of claims are “constitutionally preferable to outright suppression.” Id., citing Peel, 496 U.S. at 110; R.M.J., 455 U.S. at 206 n.20. “It is clear, then, that when government chooses a policy of suppression over disclosure--at least where there is no showing that disclosure would not suffice to cure misleadingness--government disregards a ‘far less restrictive” means” and likely fails the final prong of Central Hudson. Pearson, 164 F.3d at 658.
FDA has adopted this disclaimer and qualification approach for many of its health claims and claims of nutritional support for human food products. See, e.g., 21 C.F.R. § 101.14 and Subpart E. In the wake of Pearson, claims not supported by significant scientific agreement must be substantiated, and limitations upon the data substantiating the claims must be disclosed. Pearson, 164 F.3d at 659 (recommending disclaimers such as “The evidence in support of this claim is inconclusive” and “The FDA does not approve this claim.” This same regulatory approach would work equally well for animal feed. There is no constitutionally justifiable explanation for prohibiting animal foods from bearing the truthful, substantiated, adequately qualified claims human foods and supplements may bear.
FDA’S PRE-APPROVAL OF ALL HEALTH CLAIMS AND CLAIMS OF NUTRITIONAL SUPPORT FOR ANIMAL FOODS AND SUPPLEMENTS IS ESPECIALLY SUSPECT BECAUSE HUMAN FOODS AND SUPPLEMENTS ARE SUBJECT TO A LESSER STANDARD
An animal food or supplement, like a human food and supplement, is misbranded and an unlawful, unapproved drug if the product’s label or labeling claims the product or its ingredients cures, treats, or prevents a disease or health related condition. 21 U.S.C. § 321(g); § 352(f). However, recent developments have eased these prohibitions for human foods and supplements. With the passage of the NLEA, promulgation of implementing regulations, and ensuing litigation, foods and supplements intended for human use are not deemed to be unapproved drugs if they bear a health claim (e.g., “calcium reduces the risk of osteoporosis”) that complies with the requirements of 21 U.S.C. § 343(r) and applicable regulations.
FDA has through regulation, and when forced by litigation, permitted more information to consumers about the health benefits of the foods and supplements they consume. The ability to convey information about the health benefits of animal foods and supplements has lagged terribly behind. Human foods and supplements can bear important, useful information about the product’s healthful benefits. In contrast, providing the identical information about the identical substance in an animal food or supplement is usually unlawful. Often the information animal feed manufacturers are prohibited from disseminating concerns the same substances that provide the same benefits that are freely touted in human food labeling.
For example, glucosamine, as a human dietary supplement, is touted as providing nutritional support for human healthy joint function. Human calcium supplements and calcium-containing human foods can claim the products prevent bone thinning and osteoporosis. These claims are prohibited for animal foods and supplements unless FDA pre-approved in an NADA.
The unequal regulatory treatment of animal feed deprives companion and agricultural animal owners of valuable information and imposes enormous economic costs upon animal feed manufacturers and ingredient suppliers. The unjustified disparity in regulatory treatment will likely not withstand the scrutiny of Central Hudson and Pearson. At a minimum, FDA should use this comment opportunity to close the gap between human and animal foods and supplements.
THE DRUG PRE-APPROVAL PROCESS IS NOT A VIABLE ALTERNATIVE FOR ANIMAL FEED MANUFACTURERS AND ANIMAL FEED INGREDIENT SUPPLIERS
FDA’s pre-approval requirements unconstitutionally limit the flow of health information about animal feed and feed ingredients. Moreover, animal feed and supplements must labor under burdens not applicable to human foods and supplements. While obtaining an NADA is, theoretically, an option, numerous factors make the animal drug application and approval process very unattractive to most animal feed manufacturers and ingredient suppliers.
Many of the ingredients in animal feed are common dietary ingredients, such as vitamins, minerals, protein, yeast, enzymes, and botanicals. These substances are commonly available, are not new molecular entities, and often cannot be patented. Thus, even though these substances provide documented health benefits to animals, there is little economic incentive for the animal food manufacturers and ingredient suppliers to undertake the expense of an NADA for the benefit of a mere three or five years of marketing exclusivity. See 21 U.S.C. § 360b(b)(2)(F)(i)-(ii).
Moreover, the potential market for animal use of a dietary ingredient or similar substance is much smaller than that of humans. An NADA approval for dog food will not be applicable to horse or cattle feed. Historically, FDA also takes much, much longer to approve NADAs than it does for the agency to approve human drug applications. The lengthy, costly process and relatively low returns on the investment make obtaining an NADA a poor option for a feed manufacturer or ingredient supplier who wishes to include truthful health information on product labels and labeling.
In summary, FDA’s requirements that only animal feed products and supplements subject to approved animal drug applications may make health claims and claims of nutritional support are constitutionally infirm. FDA’s unconstitutional requirements deprive animal feed manufacturers and ingredient suppliers of the right to disseminate truthful, substantiated, qualified information about safe animal feed products. Companion and agricultural animal owners are deprived of the opportunity to receive important information about the products they feed their animals. AFIA urges FDA to seize the opportunity presented by the Request for Public Comment and address these unconstitutional and inequitable regulations and practices.
AFIA appreciates the opportunity to comment, and the agency’s consideration of these comments.
Vice President, Feed Control and Nutrition
American Feed Industry Association
1501 Wilson Blvd., Suite 1100
Arlington, VA 22209