Understanding FDA's "Magic Words"

Understanding FDA's "Magic Words"

by Jim Lassiter

There really isn't any magic in the Federal Food, Drug and Cosmetic Act (FFDCA). It only appears that way. FFDCA essentially assigns products to classes based on the claims made about them. Primary definition comes from the use of five common words in the English language. If a product claims to cure, treat, diagnose, prevent or mitigate any disease or disease state, it is classified as a drug. It's just that simple. Use any of these five "magic words" in a claim and presto--the product is a drug regardless of form or presentation.

Then there is the interpretation of the meaning of the words disease or disease state and the additional, non-statutory magic words that will equally render your product a drug. The Food and Drug Administration (FDA) has taken great pains to review the English language and identify additional words that ultimately place your product in the category of drugs. The synonyms for the original five magic words are equally applicable and this interpretation is understandable. However, FDA's linguistic review reaches beyond this. The focus of wording resides primarily in making claims for dietary supplements. FDA has in place a Final Rule (Section 101.93 of the United States Code of Federal Regulations, Title 21) mandating that companies submit their so-called "structure/function claims" within 30 days of first use in the marketplace. This rule insists that virtually all claims on dietary supplement products must be submitted for FDA review. How is this involved in the magic word listing? The answer is simple. FDA is, through its actions in commenting negatively on the submitted claims, adding to the list of magic words.

First, let's take the word cholesterol. FDA has long objected to claims for products other than drugs concerning a substance's effect on cholesterol. Every human being has a certain level of cholesterol. If a substance in a dietary supplement is capable of lowering cholesterol levels, even if the company has complete substantiation of this fact, making a claim concerning this effect renders your product a drug. Why? Because FDA says so. In their view, cholesterol is the de facto sixth magic word. FDA contends that the average consumer relates cholesterol levels to coronary artery and heart disease.

"FDA ... [reviewed the comments submitted concerning cholesterol claims and] does not believe that any of them have provided a principle that distinguishes between claims that consumers will understand as disease claims and those that will not be understood as disease claims." (65 Federal Register, Jan. 6, 2000, p. 1015)

As for what would happen next, FDA allowed that:

"... [it] will review all cholesterol claims to determine whether the labeling as a whole implies that the product is intended to lower elevated cholesterol levels. In such cases, FDA would consider the labeling to create an implied disease claim." (Ibid, p. 1019)

Thus far, the results speak for themselves. FDA has probed the mind of the consumer and determined any claim submitted that uses the word cholesterol is an implied disease claim and thus renders the product a drug. This disallows the claim and supports the magic contained in the single word. Thus, if you state your product has an impact on cholesterol levels, you have (in FDA's consumer mind-reading) made a claim concerning these serious diseases. This is an interesting interpretation of the law as written since cholesterol is clearly a "structure" in the human body. This position is one of long standing and there are no allowable "structure/function" claims for dietary supplements and cholesterol in spite of FDA's contention that one could be made. (Ibid, p. 1017-1019.) The issuance of negative responses to companies attempting to comply with FDA's suggestion is sufficient evidence of this. Therefore, cholesterol claims remain available exclusively to drug products, even if the statement is truthful and not misleading. The truth simply does not matter when consideration and interpretation of FDA's mind-reading takes place.

As time progresses, evidence mounts (witness FDA's issued courtesy letters to the makers of dietary supplements) that there are other words gaining magical status. Blood sugar and blood fat are approaching this level of magic. Claims that a product may help maintain healthy blood sugar levels will receive objection from FDA. Why? FDA believes that, in the consumer's mind, reference to blood sugar levels means only one thing: diabetes. A serious disease to be certain, but the stretch from the words blood sugar solely to diabetes is a link made exclusively in FDA's interpretation. Similarly, blood fat (or lipids) is gaining magical properties. Review of the claims submitted and subsequently rejected by FDA demonstrates that they have read the minds of consumers again and found correlation between this structure and a disease in the consumer's consciousness. Again, this is in spite of FDA's published position in the preamble to the final rule (21CFR 101.93).

"... if the statement were ... 'use as part of your diet to help maintain a healthy blood sugar level,' the claim would be considered acceptable." (Ibid, p. 1028)

However, the reality is that companies have been issued courtesy letters after submitting claims that are virtually identical to the quotation presented here. The apparent mind-probe FDA applies to consumers continues and its interpretation of the results evolves.

What happened? A brief historical review sheds some light on the matter. Some years ago, before the final rule on "structure/function" claims came into being, FDA discussed its then proposed rule with industry. FDA's perspective was that there exists a "continuum of understanding" in the consumer's mind that apparently FDA alone has tapped into. This in part serves to explain FDA's position on cholesterol claims. As a further example, at that time, FDA allowed mention of a dietary supplement's effect in lowering homocysteine levels in a "structure/function" claim. The agency noted that it did not believe the consumer makes a direct connection between homocysteine levels and heart disease. At least not then. As of today, it is possible that you can, with appropriate substantiation, make a claim that your product lowers homocysteine levels. If, however, we project this model and FDA's mind-reading abilities into the future, you have the following scenario:

Company A sells a product that is demonstrated to lower homocysteine levels in humans. Company A makes a label claim concerning this fact, submits it and receives no negative feedback. Company A is interested in providing further information and education to the consumer regarding the relevance of homocysteine levels. It proceeds to offer additional truthful, non-misleading information in its labeling and advertising. This information discusses the significance of homocysteine levels and what their control might mean. Company A continues this practice for some time and attains a solid reputation for being concerned about educating the public. However, if it does too good a job--that is if it promotes consumer awareness that elevated homocysteine levels are potentially indicative of heart disease at too high a level--trouble results. FDA continues to perform its mind-reading act. Once FDA divines that the consumer, ironically through Company A's efforts, understands the link between elevated homocysteine levels and heart disease, Company A (and everyone else) is suddenly precluded from making any claims concerning homocysteine and homocysteine becomes another of the magic words. This disallowance theoretically continues until the existing consumer population dies off and a fresh batch of naïve consumers enters the market without such awareness. Then Company A could again tout the benefits of its product.

The absurdity of this flies in the face of the wording of the Dietary Supplement Health and Education Act (DSHEA). When passed in 1994, the intent (as spelled out by Congress) included:

"... there is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health; consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements ..." [emphasis added] (Public Law 103-417, Dietary Supplement Health and Education Act of 1994, Section 2, (7), (8))

Congress was also specific in directing FDA to avoid hindering the consumer from gaining information concerning the benefits of dietary supplements:

"... although 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 ... accurate information to consumers ..." [emphasis added] (Ibid, Section 2, (13))

FDA's take on this is presented in the preamble to the Final Rule:

"Although Congress, in enacting DSHEA, did expand the scope of information in dietary supplement labeling by providing for claims to affect the structure or function of the body and the other types of claims ... Congress also explicitly limited statements to those that do not claim to 'diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.' This rule does not create new restrictions but merely implements the provisions ... of the act." (65 Federal Register, Jan. 6, 2000, p. 1036-1037)

Clearly, Congress did not anticipate the mind-reading capabilities of FDA and its subsequent ability to apply regulations based on this bit of telepathic capacity. The real challenge, therefore, is how does the dietary supplement industry provide the E in DSHEA (remember, it stands for Education) without cutting itself off from continuing the education? Perhaps FDA's ability could be overwhelmed by an industry capable of performing as the old radio show hero The Shadow did. They could gain the ability to "cloud men's minds." This would prevent the information offered from remaining in the consumer's thoughts or perhaps block FDA's imaging abilities as it delves into the consumer's consciousness.

How can this be solved? There appears to be no easy method, but there are options. The efforts of the plaintiffs and attorneys in the Pearson v. Shalala decision addressed a similar matter concerning health claims from a free speech perspective. The situation with this other class of claims is little different. We can assume that the ability to speak freely about the "structure/function" effects of dietary supplements is protected by the First Amendment to the Constitution and further affirmed in DSHEA. This would dismiss the mind reading results applied today. Taking on FDA in this matter through litigation is an expensive proposition but is becoming the only available option.

An opportunity to fight this matter inexpensively is not as obvious, yet the opportunity still exists. Another glimpse into recent history concerning these claims is useful. When the current Section 101.93 was a proposed rule, comments flew to FDA concerning the intent of the rule and how badly written it was. Universal agreement from the trade associations representing the dietary supplement industry and from other consumer groups (whose minds apparently were not read well by FDA) requested that the rule be withdrawn and redrafted. FDA's response to these requests was to publish the Final Rule. Subsequent petitions from some (only after severe prompting from industry members) modestly addressed the errors made in FDA's Final Rule action, but the industry as a whole did little else to object. Rather than fight for the original proposition that the rule be withdrawn and redrafted, the industry accepted the Final Rule and allowed FDA's Kreskin-like approach to continue to interpret what the consumer is thinking and, in the end, permitted the list of magic words to grow.

To date, the petitions have not received response from FDA. There remains opportunity to re-address the issue directly with FDA owing to this lack of response. This can only be accomplished, however, if the industry recognizes the reality of an increasingly limited claims territory--which is continually narrowed by FDA's clairvoyance--and determines to take action. Direct address of the issue through a petitioning processes will at least gain FDA's attention and force the issue into the open. The dietary supplement industry must, however, demonstrate resolve and take strong action on the matter without the cost of litigation. Through its magic act, FDA creates an ever-smaller range of acceptable claims.

Clearly, without action from the industry, the acceptable claims territory will continue to shrink as the list of magic words grows. The real loss, though, comes to the consumer who still craves accurate information regarding the potential benefits of his dietary supplements and who will find less and less information available to him.*

Jim Lassiter is president of the Lassiter Group, a regulatory consulting firm based in Laguna Beach, Calif.