Todd Harrison, Partner, Venable11.01.13
Admittedly, structure/function claims are not easy to develop. The line between a permissible and impermissible claim can be difficult to discern, even for the most experienced copywriters, regulatory affairs personnel and attorneys. FDA has promulgated a set of rules to help guide companies in drafting permissible claims. However, the agency has been inconsistent in its application. To help provide some clarity, a summary of those rules follows below, and you can find the rules at 21 CFR 101.93.
1. A claim may not suggest that the product has an effect on a specific disease or class of disease [21 CFR 101.93(g)(2)(i)].
Examples of impermissible claims under this criterion are: Reduces the pain and stiffness associated with arthritis; Helps alleviate the pain associated with migraine headaches.
Examples of claims that do not violate this criterion are: Helps build and strengthen joint cartilage; Helps maintain a healthy heart.
2. A claim may not refer to a characteristic sign or symptom of a disease or class of disease [21 CFR 101.93(g)(2)(ii)].
Examples of impermissible claims under this criterion are: Helps alleviate cloudy vision; Relieves painful joints (widely ignored by the joint health industry); Helps lower cholesterol levels (widely ignored within the industry).
FDA considers these claims impermissible because they are so associated with specific disease conditions or risk of disease (i.e., cataracts, arthritis and heart disease). However, while FDA has sent warning letters over cholesterol claims, it has not gone further if the offending claim has not stopped. Indeed, a reasonable argument exists that a simple “helps lower cholesterol” claim, without any other indicia that the claim is a “reduces the risk of heart disease” claim, is a permissible structure/function claim. Of course, this assumes that the product does not contain a nutrient or dietary ingredient that is the subject of an FDA-permitted health claim.
Examples of claims that are permissible under this criterion are: Helps maintain healthy LDL cholesterol levels that are already in the normal range; Helps maintain proper joint function; Helps alleviate minor aches and pains associated with strenuous exercise.
3. References to signs and/or symptoms of natural states are permissible as long as they are not uncommon and cannot cause significant harm if left untreated [21 CFR 101.93(g)(2)(iii)].
Examples of impermissible claims under this criterion are: Helps reduce inflammation by blocking the COX-2 enzyme; Helps alleviate BPH; Helps with erectile dysfunction.
Examples of permissible claims under this criterion are: Alleviates symptoms associated with PMS; Promotes sexual vigor and performance.
FDA’s position on inflammation (that all inflammation claims are disease claims) is nonsensical. Inflammation is happening in our bodies as you read this article, and it is important to maintain a healthy inflammatory response for overall health. Thus, while inflammation may be characteristic of certain diseases, it is also an indication of overall good health and should be considered a proper structure/function claim. Similarly, cholesterol, blood pressure, blood sugar and triglycerides are also indications of overall good health, and reducing these levels that are in the high-end of the normal range should be encouraged and not discouraged.
More on this issue in a moment.
4. A claim may not be disguised as a product name [21 CFR 101.93(g)(2)(iv)(A)].
Examples of impermissible product names are: Cho-less-terol; Arthex; Diab-eet-ees.
There are many companies that believe if a product name is trademarked, it is not subject to FDA’s rules or FTC’s requirement that a claim be substantiated. It is clear from both an FDA and FTC perspective that if a product name communicates a particular meaning (alleviates migraines), it is subject to the same rules as any other product claim. Accordingly, do not use a disease condition in the product name under the false assumption that neither the FDA nor the FTC can take issue with the brand name.
Examples of permissible product names are: Mood Health; Joint Flex; Heart Health
5. A claim may not refer to a supplement’s formulation if the statement suggests that the product is/was an FDA-regulated drug and it is well known to be used to prevent or treat a disease or health-related condition [21 CFR 101.93(g)(2)(iv)(B)].
6. Citations to an article that refers to a disease in its title are permissible if the labeling, taken as a whole, does not imply a disease prevention or treatment claim [21 CFR 101.93(g)(2)(iv)(C)].
However, reference to an article that refers to a disease is not permitted on the product’s label or immediate packaging. To ensure compliance with this criterion, the article 1) should not be characterized in the copy; 2) should appear at the end of the promotional materials as part of a bibliography of other articles; and 3) the article should be balanced. Moreover, a bibliography that contains more than an insignificant number of articles that refer to a particular disease would be considered suspect by FDA and should be avoided.
7. The use of the terms disease, diseases, antiviral, antibacterial, antiseptic, antibiotic, diuretic, antidepressant, vaccine, analgesic or any other word that would suggest that the product belonged to a class of products intended to cure, treat or prevent disease, is not permitted [21 CFR 101.93(g)(2)(iv)(D)].
Examples of impermissible claims are: Stimulates the body’s antiviral capacity; A natural analgesic without the side effects associated with NSAIDs.
Examples of permissible claims are: Helps maintain proper immune function; Helps reduce stress and tension; Helps alleviate occasional constipation.
8. The use of pictures, vignettes, symbols or other means in a manner that would otherwise suggest the presence of a disease condition is not permitted [21 CFR 101.93(g)(2)(iv)(E)].
A picture of a hand with the joints highlighted in red may be considered an implied “disease” claim because the red highlight could be interpreted as a sign of pain or arthritis. Alternatively, however, a picture of a hand, standing alone, would probably not be considered a “disease” claim because it does not reference a particular endpoint—joints and pain.
FDA takes the absurd position that the heart symbol is an implied disease claim. This position is illogical as the claim, “Helps support a healthy heart,” is a permissible structure/function claim.
9. A claim may not suggest that the supplement or its ingredients belong to a particular class of drugs or are a substitute for a particular therapy [21 CFR 101.93(g)(2)(v) and (vi)].
Examples of impermissible claims are: Herbal antidepressant; Helps maintain joint health without the use of NSAIDs.
10. A claim may not suggest that a product is useful as a companion to regular drug therapy or that it prevents or treats adverse events associated with a disease if the adverse events are also disease conditions [21 CFR 101.93(g)(2)(vii) and (ix)].
Examples of impermissible claims are: Helps maintain blood sugar levels in insulin-dependent people; Helps stimulate the immune system when undergoing chemotherapy; Helps individuals using antibiotics to maintain normal intestinal flora.
11. FDA also has a catch-all-rule to allow it to complain about any claim it does not believe is a permissible structure/function claim [21 CFR 101.93(g)(2)(x)].
Imperfect Guidance
As you can see, the rules are hardly perfect, and one good rule of thumb to use when drafting claims is to keep it simple and to avoid a negative spin to the claim. In other words, write the claim in a manner that assumes the product is helping to support a normal structure/function of the body rather than trying to correct an abnormal condition. By doing so, you will generally be able to avoid impermissible claims that could subject the product to regulatory scrutiny, which comes to my point of this column.
Certain industry trade associations have decided that whether a claim is appropriately a structure/function claim is black and white. Recently, one trade association—at least privately—has taken the position that claims such as “supports normal triglycerides” or “reduces triglycerides” should be subject to FDA’s new drug approval process and its exacting high standard for new drugs.
Reflecting this position, the trade association referenced a few warning letters in which FDA objected to references to “reducing high triglycerides.” The trade association, however, ignored that the thrust of the warning letters were that these companies were making very serious disease claims and that the references to “high triglycerides” were not the real purpose of the warning letter.
Indeed, FDA will often throw in the kitchen sink when it believes a company’s conduct is particularly egregious, even though under normal circumstances it would not even rise to the level of sending an untitled letter. Thus, when attempting to find clues in warning letters, one must look at the real conduct FDA is complaining about and not some of the ancillary conduct referenced in the letter.
Regardless, it seems odd that a trade association would take a position that simply supporting normal triglyceride levels or reducing triglycerides levels, without more, should be considered a disease claim that can only be made if FDA has approved the claim through the drug approval process. Indeed, the industry should not simply cede a position because FDA believes something is not permissible.
The discussion over inflammation is the perfect example of this situation. FDA does not like any inflammation claim, even if it is qualified to refer to normal inflammatory responses (e.g., in response to strenuous exercise). Yet, maintaining proper inflammatory response is necessary to the overall health of the body. Thus, I would argue that FDA’s position is wrong as a matter of law.
Unfortunately, a trade association’s position that “supports normal triglycerides” or “reduces triglycerides” are disease claims only lends credence to FDA’s position, although the industry likely opposes this position as a whole.
No Clear Line to Draw
Quite frankly, if everyone were to be honest, there is not a structure/function claim that could not be considered an implied disease claim. For instance, supports a “healthy heart” could be reasonably interpreted as an implied “reduce the risk of heart disease” claim. Yet, I think we would all agree, including FDA, that it is a permissible structure/function claim. I would argue that claims such as “supports normal triglycerides;” “supports normal cholesterol levels;” and “supports normal blood pressure levels” are permissible structure/function claims, and the addition of the phrase “in the normal range” is unnecessary because it conveys the same meaning.
I would further argue that claims such as “helps lower blood pressure” should also be considered permissible structure/function claims because high blood pressure is defined as 140/90, and lifestyle factors can play a significant role in lowering high-normal blood pressure of 139/89. Indeed, dietary intervention at Stage 1 can have a significant impact on blood pressure. Yet, if we do not allow truthful structure/function claims, then what purpose does the Dietary Supplement Health and Education Act (DSHEA) serve? Should we simply put everyone on a drug? At a minimum, companies should be able to qualify a claim to state that it will lower numbers that would be considered on the high side of normal. This is a policy debate worth having, and the preeminent trade associations in the industry should be leading this fight rather than taking positions that undermine the industry.
I would urge everyone to contact their trade association and make it clear that the permissibility of structure/function claims is not a bright line and that industry trade associations should not take positions that undermine this position. Moreover, we as an industry should engage in this debate in an open and honest manner and not attempt to advance policy arguments, as it will only come back to haunt the industry if other entities that provide oversight decide to wade into the murky water of whether a claim is a disease claim, rather than a permissible structure/function claim, thereby subjecting the product to the drug approval process. Plaintiff lawyers have already started to allege this in class-action cases, and a trade association taking this position only adds credence to it.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
1. A claim may not suggest that the product has an effect on a specific disease or class of disease [21 CFR 101.93(g)(2)(i)].
Examples of impermissible claims under this criterion are: Reduces the pain and stiffness associated with arthritis; Helps alleviate the pain associated with migraine headaches.
Examples of claims that do not violate this criterion are: Helps build and strengthen joint cartilage; Helps maintain a healthy heart.
2. A claim may not refer to a characteristic sign or symptom of a disease or class of disease [21 CFR 101.93(g)(2)(ii)].
Examples of impermissible claims under this criterion are: Helps alleviate cloudy vision; Relieves painful joints (widely ignored by the joint health industry); Helps lower cholesterol levels (widely ignored within the industry).
FDA considers these claims impermissible because they are so associated with specific disease conditions or risk of disease (i.e., cataracts, arthritis and heart disease). However, while FDA has sent warning letters over cholesterol claims, it has not gone further if the offending claim has not stopped. Indeed, a reasonable argument exists that a simple “helps lower cholesterol” claim, without any other indicia that the claim is a “reduces the risk of heart disease” claim, is a permissible structure/function claim. Of course, this assumes that the product does not contain a nutrient or dietary ingredient that is the subject of an FDA-permitted health claim.
Examples of claims that are permissible under this criterion are: Helps maintain healthy LDL cholesterol levels that are already in the normal range; Helps maintain proper joint function; Helps alleviate minor aches and pains associated with strenuous exercise.
3. References to signs and/or symptoms of natural states are permissible as long as they are not uncommon and cannot cause significant harm if left untreated [21 CFR 101.93(g)(2)(iii)].
Examples of impermissible claims under this criterion are: Helps reduce inflammation by blocking the COX-2 enzyme; Helps alleviate BPH; Helps with erectile dysfunction.
Examples of permissible claims under this criterion are: Alleviates symptoms associated with PMS; Promotes sexual vigor and performance.
FDA’s position on inflammation (that all inflammation claims are disease claims) is nonsensical. Inflammation is happening in our bodies as you read this article, and it is important to maintain a healthy inflammatory response for overall health. Thus, while inflammation may be characteristic of certain diseases, it is also an indication of overall good health and should be considered a proper structure/function claim. Similarly, cholesterol, blood pressure, blood sugar and triglycerides are also indications of overall good health, and reducing these levels that are in the high-end of the normal range should be encouraged and not discouraged.
More on this issue in a moment.
4. A claim may not be disguised as a product name [21 CFR 101.93(g)(2)(iv)(A)].
Examples of impermissible product names are: Cho-less-terol; Arthex; Diab-eet-ees.
There are many companies that believe if a product name is trademarked, it is not subject to FDA’s rules or FTC’s requirement that a claim be substantiated. It is clear from both an FDA and FTC perspective that if a product name communicates a particular meaning (alleviates migraines), it is subject to the same rules as any other product claim. Accordingly, do not use a disease condition in the product name under the false assumption that neither the FDA nor the FTC can take issue with the brand name.
Examples of permissible product names are: Mood Health; Joint Flex; Heart Health
5. A claim may not refer to a supplement’s formulation if the statement suggests that the product is/was an FDA-regulated drug and it is well known to be used to prevent or treat a disease or health-related condition [21 CFR 101.93(g)(2)(iv)(B)].
6. Citations to an article that refers to a disease in its title are permissible if the labeling, taken as a whole, does not imply a disease prevention or treatment claim [21 CFR 101.93(g)(2)(iv)(C)].
However, reference to an article that refers to a disease is not permitted on the product’s label or immediate packaging. To ensure compliance with this criterion, the article 1) should not be characterized in the copy; 2) should appear at the end of the promotional materials as part of a bibliography of other articles; and 3) the article should be balanced. Moreover, a bibliography that contains more than an insignificant number of articles that refer to a particular disease would be considered suspect by FDA and should be avoided.
7. The use of the terms disease, diseases, antiviral, antibacterial, antiseptic, antibiotic, diuretic, antidepressant, vaccine, analgesic or any other word that would suggest that the product belonged to a class of products intended to cure, treat or prevent disease, is not permitted [21 CFR 101.93(g)(2)(iv)(D)].
Examples of impermissible claims are: Stimulates the body’s antiviral capacity; A natural analgesic without the side effects associated with NSAIDs.
Examples of permissible claims are: Helps maintain proper immune function; Helps reduce stress and tension; Helps alleviate occasional constipation.
8. The use of pictures, vignettes, symbols or other means in a manner that would otherwise suggest the presence of a disease condition is not permitted [21 CFR 101.93(g)(2)(iv)(E)].
A picture of a hand with the joints highlighted in red may be considered an implied “disease” claim because the red highlight could be interpreted as a sign of pain or arthritis. Alternatively, however, a picture of a hand, standing alone, would probably not be considered a “disease” claim because it does not reference a particular endpoint—joints and pain.
FDA takes the absurd position that the heart symbol is an implied disease claim. This position is illogical as the claim, “Helps support a healthy heart,” is a permissible structure/function claim.
9. A claim may not suggest that the supplement or its ingredients belong to a particular class of drugs or are a substitute for a particular therapy [21 CFR 101.93(g)(2)(v) and (vi)].
Examples of impermissible claims are: Herbal antidepressant; Helps maintain joint health without the use of NSAIDs.
10. A claim may not suggest that a product is useful as a companion to regular drug therapy or that it prevents or treats adverse events associated with a disease if the adverse events are also disease conditions [21 CFR 101.93(g)(2)(vii) and (ix)].
Examples of impermissible claims are: Helps maintain blood sugar levels in insulin-dependent people; Helps stimulate the immune system when undergoing chemotherapy; Helps individuals using antibiotics to maintain normal intestinal flora.
11. FDA also has a catch-all-rule to allow it to complain about any claim it does not believe is a permissible structure/function claim [21 CFR 101.93(g)(2)(x)].
Imperfect Guidance
As you can see, the rules are hardly perfect, and one good rule of thumb to use when drafting claims is to keep it simple and to avoid a negative spin to the claim. In other words, write the claim in a manner that assumes the product is helping to support a normal structure/function of the body rather than trying to correct an abnormal condition. By doing so, you will generally be able to avoid impermissible claims that could subject the product to regulatory scrutiny, which comes to my point of this column.
Certain industry trade associations have decided that whether a claim is appropriately a structure/function claim is black and white. Recently, one trade association—at least privately—has taken the position that claims such as “supports normal triglycerides” or “reduces triglycerides” should be subject to FDA’s new drug approval process and its exacting high standard for new drugs.
Reflecting this position, the trade association referenced a few warning letters in which FDA objected to references to “reducing high triglycerides.” The trade association, however, ignored that the thrust of the warning letters were that these companies were making very serious disease claims and that the references to “high triglycerides” were not the real purpose of the warning letter.
Indeed, FDA will often throw in the kitchen sink when it believes a company’s conduct is particularly egregious, even though under normal circumstances it would not even rise to the level of sending an untitled letter. Thus, when attempting to find clues in warning letters, one must look at the real conduct FDA is complaining about and not some of the ancillary conduct referenced in the letter.
Regardless, it seems odd that a trade association would take a position that simply supporting normal triglyceride levels or reducing triglycerides levels, without more, should be considered a disease claim that can only be made if FDA has approved the claim through the drug approval process. Indeed, the industry should not simply cede a position because FDA believes something is not permissible.
The discussion over inflammation is the perfect example of this situation. FDA does not like any inflammation claim, even if it is qualified to refer to normal inflammatory responses (e.g., in response to strenuous exercise). Yet, maintaining proper inflammatory response is necessary to the overall health of the body. Thus, I would argue that FDA’s position is wrong as a matter of law.
Unfortunately, a trade association’s position that “supports normal triglycerides” or “reduces triglycerides” are disease claims only lends credence to FDA’s position, although the industry likely opposes this position as a whole.
No Clear Line to Draw
Quite frankly, if everyone were to be honest, there is not a structure/function claim that could not be considered an implied disease claim. For instance, supports a “healthy heart” could be reasonably interpreted as an implied “reduce the risk of heart disease” claim. Yet, I think we would all agree, including FDA, that it is a permissible structure/function claim. I would argue that claims such as “supports normal triglycerides;” “supports normal cholesterol levels;” and “supports normal blood pressure levels” are permissible structure/function claims, and the addition of the phrase “in the normal range” is unnecessary because it conveys the same meaning.
I would further argue that claims such as “helps lower blood pressure” should also be considered permissible structure/function claims because high blood pressure is defined as 140/90, and lifestyle factors can play a significant role in lowering high-normal blood pressure of 139/89. Indeed, dietary intervention at Stage 1 can have a significant impact on blood pressure. Yet, if we do not allow truthful structure/function claims, then what purpose does the Dietary Supplement Health and Education Act (DSHEA) serve? Should we simply put everyone on a drug? At a minimum, companies should be able to qualify a claim to state that it will lower numbers that would be considered on the high side of normal. This is a policy debate worth having, and the preeminent trade associations in the industry should be leading this fight rather than taking positions that undermine the industry.
I would urge everyone to contact their trade association and make it clear that the permissibility of structure/function claims is not a bright line and that industry trade associations should not take positions that undermine this position. Moreover, we as an industry should engage in this debate in an open and honest manner and not attempt to advance policy arguments, as it will only come back to haunt the industry if other entities that provide oversight decide to wade into the murky water of whether a claim is a disease claim, rather than a permissible structure/function claim, thereby subjecting the product to the drug approval process. Plaintiff lawyers have already started to allege this in class-action cases, and a trade association taking this position only adds credence to it.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
