FDA proposes rule clarifying evidence for determining product’s intended use

Recently, the U.S. Food and Drug Administration issued a statement and proposed rule clarifying the types of evidence that the FDA considers when determining the "intended use" of a product. Intended use is important because it determines whether, and how, a product is regulated by the agency.

There are several ways in which product manufacturers can run afoul of the FDA (and other agencies like the Federal Trade Commission and the Department of Justice), when promoting and advertising products beyond their approval or clearance. Examples include:

(1) Dietary supplement manufacturers who make drug claims -- for example: "Vitamin C cures COVID-19."

(2) Cosmetics manufacturers who attempt to sell product as a cosmeceutical (e.g., a product that claiming both a cosmetic and a pharmaceutical benefit).

(3) Drug manufacturers who promote off-label use in a way that is false or misleading. For example: "our drug, which is approved to increase ocular moisture, also is good for treating age related macular degeneration," when there is no evidence that the drug may be effective as a treatment for the disease.

Advertising and promotional claims that go beyond an approved or cleared intended use can, in some instances, result in a product being misbranded. Misbranded products subject to the FDA, will be issued warning letters that will require corrective action by the product manufacturer.

The Proposed Rule

The proposed rule lists evidence that the FDA will consider in determining intended use, as well as evidence the FDA will not employ by itself when the agency makes a determination of intended use.

Express Claims and Representations

These include: "labeling claims and representations," as well as "advertising matter, and oral or written statements by persons responsible for the labeling, or their representatives."

Implied Claims

The proposed rule defines an implied claim as any "claim or statement made by or on behalf of a firm that implicitly represents a product for a particular use." Suggestive names can give rise to implied claims. For example, the proposed rule exemplifies the name Shroomz (presumably implying that Shroomz produces the same effects as psilocybin, a component of magic mushrooms, that is converted in the body to psilocin which has psychoactive properties).

Statements of use, such as "[f]or best results use approximately 30-45 minutes prior to engaging in sexual intercourse," are also cited as potentially conveying implied claims.

Product Characteristics and Design

Here, the proposed rule, as an example, cites to products containing 2,4-dinitrophenol, known as DNP. DNP was used in the early part of the last century for weight loss. DNP was effective because it inhibited adenosine triphosphate production in mitochondria. While DNP was effective for weight loss, it unfortunately also led to over 60 deaths because of associated toxicities including hyperthermia, tachycardia, diaphoresis and tachypnoea. Thus, the proposed rule cites to inclusion in a product of any substance as a product characteristic where the substance has "known physiological effects" and is "unapproved for any medical use."

The proposed rule also cites to product designs or features. An example in this evidence class includes "a stent that is specifically sized for a use that is different from the purported use" and "a device that includes software with a diagnostic function when the purported use does not include diagnosis." Taking the last example, in a scenario where a manufacturer included a diagnostic function in the software, but kept the function locked and intended the lock to remain until the manufacturer could obtain 510(K) clearance for the diagnostic function software, is this evidence of an intended use?

Circumstances of the Sale or Distribution

This includes to whom and for whom the products are offered. Examples include, for a drug, a firm's "repeated proactive detailing and delivery of large amounts of product samples to a health care provider whose patient population does not fall within the product's approved population."

Safe Harbors

The proposed rule also includes safe harbors that, standing alone, are not determinative of intended use. For example, the proposed rule states that "a firm will not be regarded as selling an unapproved product based solely on that firm's knowledge that the product is being prescribed or used by health care providers for such use."

Also, the proposed rule recites that "knowledge in combination with conduct that falls within a safe harbor would not be determinative of intended use."

Analysis

The proposed rule follows on the heels of earlier attempts, transpiring over several years, to arrive at a final rule. Why has this become a multi-year process? In part, the answer is because intended use and evidence of intended use, at times, is not clear cut; and in part because product manufacturers have commercial free speech rights under the First Amendment.

For example, under the proposed rule, statements of use, such as "[f]or best results use approximately 30-45 minutes prior to engaging in sexual intercourse," are also cited as potentially conveying implied claims. That directions or partial directions for use may convey intended use, exemplifies the lack of clarity that can arise when the agency determines intended use under an implied claim.

If the above statement of use is on a breath freshener, what does that imply about intended use? Does the combination of the product and the directions for use imply that using a breath freshener before sexual intercourse could make the act more pleasurable? Or interpreted more broadly, would the agency construe the specificity of the timing of use to conclude that the breath freshener directions imply an intended use (similar to an erectile dysfunction drug) because the directions do not say to use "anytime breath should be fresh"?

What if the supplement also is indicated for promoting a healthy cardiovascular system, or healthy mitochondria? Both of these are implicated in the ability to have sexual intercourse. How would the agency view the totality of these circumstances?

As is clear, aspects of the proposed rule leave open significant zones of uncertainty.

On the other hand, for product design features, what if a dietary supplement, indicated for helping maintain a healthy reproductive system, is present in a bottle whose shape could suggest the presence of an erection? How would the agency treat this?

And, under circumstances of sale or distribution, what if a physician, who previously has not practiced in an area of medicine, now decides to expand her practice into this new area and has asked, on two separate occasions, for drug samples. The proposed rule exemplifies "repeated proactive detailing and delivery of large amounts of product samples to a health care provider whose patient population does not fall within the product's approved population." How would the FDA view this situation?

Finally, one safe harbor example that applies to all cases, deals with distributing truthful and non-misleading information at a conference. While this example seems clear, when does the agency consider publications or statements to cross the non-misleading line (remembering that truthful and non-misleading speech is constitutionally protected). How would that square with commercial free speech provisions? Especially in light of earlier actions where the agency and the DOJ took employees and executives to court, focusing their court cases on statements that were truthful -- and ultimately found by courts to be truthful. We just don't know the answer to this.

Conclusion

The agency's determination of intended use, and what constitutes evidence of intended use, does not always follow bright line rules. And companies in certain circumstances enjoy First Amendment commercial free speech protections. Marketing regulated products while navigating these legal waters can be tricky, and companies are encouraged to involve counsel early and regularly.