Qualified Health Claims permit nutrient-disease risk reduction claims to be made for dietary supplements without fear of FDA or FTC enforcement. The FDA allows such claims in reliance on its “enforcement discretion,” following submission of a health claim petition. The FDA’s “enforcement discretion” is a euphemism because the agency is constitutionally barred by precedent in Pearson v. Shalala and its progeny from acting against claims backed by credible scientific evidence (including evidence that is inconclusive). On behalf of Durk Pearson and Sandy Shaw, Emord & Associates sued the FDA and defeated the agency on First Amendment grounds, leading to the court ordered creation of the qualified health claims regime at the agency. Go here for a listing of all qualified health claims obtained by Emord & Associates for its clients, and here for a listing of the firm’s victories over FDA denials of claims.
FDA has begrudgingly implemented only part of the federal courts’ constitutional mandates and refuses to honor the letter and spirit of those decisions. The Federal Trade Commission defers to the FDA’s decisions on qualified health claims and, so, does not take enforcement action against them. Without an approved claim, any statement in labeling or advertising that reveals an intent to sell a dietary supplement for use in the cure, treatment, prevention, or mitigation of disease turns a “dietary supplement” into an unlawful, “unapproved new drug” under the federal Food Drug and Cosmetic Act (FDCA). A qualified health claim accomplishes more than just a labeling exemption at the point-of-sale. The qualified claim can also restore value to the Third Party Labeling Exemption, a statutory provision undercut dramatically by FDA’s application of the intended use doctrine.
For years the FDA has substantially limited the flow of information that should be accessible to consumers through the “third party labeling” exemption in 21 U.S.C. § 343-2. FDA also resisted Congressional attempts to expand the free-flow of scientific information to consumers based on authoritative government statements concerning nutrient-disease relationships. In the FDA Modernization Act of 1997, Congress expressly permitted use in food labeling of nutrient content claims and health claims based on authoritative statements issues by other governmental bodies. See generally Food Labeling: Health Claims; Antioxidant Vitamins C and E and the Risk in Adults of Atherosclerosis, Coronary Heart Disease, Certain Cancers, and Cataracts, 63 Fed. Reg. 34084 (June 22, 1998). FDA has refused to obey that clear legislative command. FDA determined through rulemaking that such “authoritative statements” could only support health claims if those claims also satisfied FDA’s rigorous “significant scientific agreement” (SSA) standard. See id. at 34086. FDA determines for itself whether the SSA standard is satisfied based on existing evidence. Unsurprisingly, therefore, the agency’s interpretation dramatically undercut the “authoritative statements” exemption in 21 U.S.C. § 343(r)(2)(G), which was supposed to be a less restrictive alternative to, not a re-embodiment of, the SSA standard.
The Dietary Supplement Health and Education Act (DSHEA), enacted in 1994, contained two significant statutory sections intended to expand consumer access to information about dietary supplements. See 21 U.S.C. §§ 343(r) and 343-2. Section 343(r) authorized “health claims” for dietary supplements. Section 343-2 authorized the dissemination of truthful and non-misleading scientific information under certain conditions. Both sections are “labeling” exemptions, allowing certain statements and information to be displayed at the point of sale, or in conjunction with a sale. Section 343-2 provides, in pertinent part:
A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers when it:
- is not false or misleading;
- does not promote a particular manufacturer or brand of a dietary supplement;
- is displayed or presented, or is displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement;
- if displayed in an establishment, is physically separate from the dietary supplements; and
- does not have appended to it any information by sticker or any other method.
That “labeling” exemption, although poorly worded, should permit the dissemination of truthful scientific information directly to consumers. However, the FDA has substantially limited that option.
In the early 2000s, the internet continued its rapid growth during the dot-com bubble. The web became a powerful, readily accessible method for smaller companies to disseminate information. With the emergence of finely tuned web-browsing platforms and search engines, companies could provide volumes of scientific information through a mouse-click. When Congress enacted the DSHEA, that form of mass-dissemination was impractical with nascent technology.
Today members of the regulated industry frequently clash with FDA over internet policies. FDA’s authority over dietary supplements and foods had once focused on product labeling. “Labeling,” in the eyes of the 103rd U.S. Congress, referred to print materials affixed to the product or disseminated along with the product. The FDA expanded the “labeling” concept to keep pace with burgeoning technology. For example, in a 2007 letter to industry, the FDA explained that web pages are sometimes “labeling”:
FDA also recognizes that information available through the Internet, including those websites that provide truthful and non-misleading information about conventional food products can serve a valuable and useful function. … In certain circumstances, information that is disseminated over the Internet by, or on behalf of, a regulated company meets the definition of labeling in section 201(m) of the Act and is subject to the requirements of the Act. For example, if a company were to promote a regulated product on its website and allow consumers to purchase the product directly from the website, the website is likely to be “labeling.” As another example, if the label for a product contained a statement that referred the consumer to a specific website for additional information about a claim for the product, the website is likely to be “labeling.” The websites, in these cases, are considered written, printed, or graphic matter that supplements or explains the product and is designed for use in the distribution and sale of the product.
See Letter from B. Schneeman, Ph.D., Director of FDA’s Office of Nutritional Products, Labeling and Dietary Supplements, CFSAN (Jan. 2007).
If FDA decides that your webpage is “labeling,” the agency has an upper hand. FDA strictly regulates “labeling” content, including product claims. The third party literature labeling exemption in 21 U.S.C. § 343-2 should have limited FDA’s ability to condemn or censor certain scientific information. In other words, assuming you satisfy the five elements in Section 343-2(a), FDA should permit a full, objective scientific discussion concerning dietary ingredients—whether or not that discussion touches on diseases or abnormal health conditions, as the published literature often does. Therefore, in reliance on the Section 343-2 exemption, companies compiled scientific databases and online forums to spread vital information. They thought that Section 343-2 permitted scientific discussion even when they also sold the product or ingredient at issue.
FDA closed that door. FDA’s “intended use” doctrine swallowed the exemption. Under the “intended use doctrine,” courts allow FDA to consider any source of information when determining the seller’s intended use for the product. If the product is intended for use as a drug, FDA regulates the article accordingly. In other words, if you promote a product for a drug purpose in any way, the FDA will consider that product to be a drug. FDA examines web pages, blogs, Facebook pages, product reviews, and educational pages when classifying products. In fact, as we recently reported here, in April FDA acted against a company that published health information on unrelated webpages. According to FDA, the scientific discussion established a “drug” purpose. By hyperlinking to that content, the company established an unapproved drug use for the dietary supplement.
Put simply, under the intended use doctrine, if the science discusses a drug use (e.g., treatment, mitigation, cure, or prevention of disease), the science library could render the product a “drug.” Sellers can argue that the science also supports and acceptable claim (e.g., structure/function language), and that the promotional content clearly limits the science to that purpose. But FDA wields broad authority to draw meaning from promotional and informational content.
So what of the third party literature exemption and its five elements? Well, labeling exemption or not, if the scientific information associates a dietary supplement or its ingredients with a therapeutic use, the product is a drug. Just like that, FDA nullifies the exemption in Section 343-2 because that statue only created a “labeling” exemption. The statute does not limit FDA from considering the material under the intended use doctrine. A company selling the dietary supplement is therefore limited in the information they can disseminate concerning that dietary supplement. The solution may be qualified health claims.
How Can Qualified Health Claims Help?
A qualified health claim disables FDA of its most efficient charge: the unapproved drug claim. The qualified claim permits dissemination of science related to the disease risk-reductive effect which supported the qualified health claim petition. In other words, a company operating under an FDA-approved qualified health claim can theoretically publish scientific discussion concerning the subject disease, without fear that FDA will label the product a “drug” based on that scientific discussion. Instead, the FDA could argue that the scientific discussion misleads consumers by exaggerating the strength of science supporting the FDA-approved claim. That challenge, however, is harder for FDA to sustain because it requires proof that the scientific evidence is actually misleading or false. The qualified health claim thus restores access to the vibrant scientific discussion intended by the third party literature exemption in 21 U.S.C. § 343-2, provided, of course, that the discussion remains largely focused on disease prevention featured in the original health claim petition.
Some background on qualified health claims is helpful. A qualified health claim characterizes the relationship between a nutrient and the reduction in the risk of developing certain diseases. FDA will approve a pure health claim (unqualified claim) only when a scientific consensus shows that the claim is supported. For unqualified health claims, FDA generally requires “significant scientific agreement” by well-qualified experts in the relevant field. Qualified health claims, by contrast, are attainable when the level of scientific evidence is supportive but inconclusive. If at least some methodologically sound scientific evidence supports a claim, the First Amendment requires FDA to allow the claim subject to suitable disclaimers.
A qualified health claim begins with a health claim petition. That petition must include all relevant citations to the supportive science, along with a discussion of negative evidence. FDA examines that petition through its Evidence-Based Review System (EBRS). Under the EBRS, FDA categorizes scientific evidence based on, inter alia, methodological quality. FDA generally looks to clinical data. To the extent FDA (or a federal court) finds evidence to support the claim, the industry may use the claim in labeling or promotional material, along with a suitable disclaimer that characterizes the level of scientific support.
When approving a claim, the FDA ordinarily rejects most studies and finds that just one or two studies support the claim (often out of hundreds submitted). FDA dismisses whole categories of scientific data, including animal studies, meta studies, mechanistic studies, treatises, etc. According to FDA, that evidence only provides background information, and does not directly support the health claim. But those studies are part of the public scientific record.
After FDA approves a health claim or allows a qualified health claim, the agency cannot logically contend that the health claim is false or misleading. Moreover, the First Amendment should allow a company to disseminate information related to the petitioning process. Such information could include, for example, a detailed list of the science submitted to FDA in support of the claim. The result is a robust disclosure of scientific information, and candid discussion of that information. The scientific evidence in support might also include discussions of treatment protocols or therapeutic uses, provided that the scientific evidence also supported the qualified health claim at issue. The qualified health claim thus opens the door to an information stream apart from the approved claim language alone.
Those points notwithstanding, the costs of obtaining a qualified health claim remain significant. A claim petition requires thorough research and a willingness to press forward if FDA denies the initial petition. Health claims can be used by any company that satisfies the designated criteria. Members of industry are therefore hesitant to altruistically expend resources on a general claim that might also benefit competitors. Consumer and industry groups have joined forces to help foster the free-flow of scientific information from industry to consumers. Associations like the Alliance for Natural Heath (ANH) have contributed generously to the development and pursuit of qualified health claims. Interested companies should consider joining or contributing to similar organizations, or contacting legal counsel to determine whether their specific product could be eligible for a qualified health claim.
As the First Amendment commercial speech standards shift and courts begin to favor more freedom in the marketplace, industry could gain a significant edge on FDA in health claims cases. Health claims and third party literature schemes could stand to gain the most from recent Supreme Court and federal precedent. Do not hesitate to contact us if you have any questions concerning health claims or dietary supplement marketing.