“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
You may be familiar with this disclaimer found on dietary supplements. Why is it there? When do you, as a botanical producer, need to add this disclaimer to your products? What things is one not able to say at all about a botanical product?
A. Let’s Dig In: Drug & Disease Claims
As suggested by the disclaimer quoted above, botanical products and the people who manufacture them cannot claim to diagnose, treat, cure, or prevent any disease. Only drugs that have undergone a stringent drug-approval process with the Federal Drug Administration (FDA) or licensed medical doctors can use that language.
One quirk in the botanical products law is that the FDA classifies a product based less on its ingredients than on how you, as the manufacturer, describe the product. This is why you must carefully consider the words you choose to represent and market your botanical products. If you describe your product with words like “cure,” “treat,” or mention specific diseases, then your product becomes a drug in the eyes of the FDA. In order to conduct business without interference from the FDA, you need to be discerning with your words. This can be tricky, and we’ve provided examples on the next page of what is permissible and what is not permissible.
Specifically Regulated Botanical Ingredients
Even though it is true that botanicals are usually regulated based on how the manufacturer describes them rather than the ingredients, there are specific botanical ingredients that have caught the eye of the FDA and been either banned outright or are subject to a much higher level of scrutiny. Be aware of the following botanical ingredients that have raised concerns with the FDA. If you want to keep track of what ingredients will spark regulation by the FDA yourself, then you can visit their Dietary Supplement Ingredient Directory. On the list below are some botanical examples from this directory:Comfrey. Comfrey is a source of alkaloids, and any herbalist will tell you that oral overconsumption of this botanical can lead to liver damage. In 2001, the FDA advised that it was prepared to use its authority to remove all comfrey manufactured for internal use from shelves, effectively banning the product. Comfrey is now only sold in for topical applications in the U.S.
Ephedrine. Raw botanicals (sea grape, yellow horse, joint fir, popotillo, country mallow) can be a source of ephedrine alkaloids. The sale of dietary supplements containing ephedrine alkaloids has been banned since 2004.
Kava. In 2002, the FDA issued a safety advisory based on its association with liver damage, but did not ban the sale of the herb. Kava producers should issue a warning on their label referring to FDA’s concerns and potential side effects.
Red yeast rice. A company manufactured red yeast rice in a way that caused it to contain significant amounts of lovastatin, which happened to be the active pharmaceutical ingredient in an approved drug Mevacor. The supplement manufacturer claimed lovastatin occurred naturally in their product, but the FDA disagreed, showing that traditional red yeast rice did not contain significant amounts of the chemical. Because the lovastatin levels were significant, the FDA successfully argued that the red yeast rice product wasn’t a dietary supplement but an unapproved drug and got the product removed from the market.
B. Claims about the Impact of Ingestible Botanicals
To market your botanical products, you need to describe to your customer how the product works and the good things it will do for their health. But making the wrong kind of claim can get you into hot water. How do you know what you can and can’t say?
Generally, the safest claims to make are what are called “structure /function” claims. These claims don’t require pre-approval by the FDA. Here’s a quick summary of how to make a safe structure/function claim, and we’ll explore more further on in this section:
Summary of how to make a structure/function claim:
- Do not imply that the supplement can treat, mitigate, cure or prevent any disease,
- In fact, do not mention any specific diseases in your claim,
- Do not suggest the supplement relieves symptoms that are characteristic of a specific disease, and
- Do describe the benefits as those that support normal/healthy functioning of the body,
- Do notify the FDA of the claim you make within 30 days of marketing it, and
- Do include the following statement on the label of any product making a structure/function claim:
“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
What does this look like in practice? Examples will help illustrate the rules. See the table below for specific claims that have been allowed or disallowed by the FDA.
i. Structure/Function Claims
1) Generally allowed, with a disclaimer
Imagine desiring to write on your Elderberry syrup packaging, “supports the body’s immune defenses.” This would be permissible if you also included the disclaimer statement in italics above. But if you are making St. John’s Wort capsules, can you market it with the phrase, “heals mild to moderate depression”? Definitely not. Even if you include the disclaimer above, you’re making an impermissible statement for two reasons. First, because you specifically mention a diagnosable condition—depression (the severity is not relevant here). Second, it claims to “heal,” which is a power reserved in our society for licensed medical doctors.
Let’s look at some permissible and impermissible structure/function claims to get a better sense of what is acceptable on a botanical label and what would cause the FDA to classify your product as a drug.
TABLE 2. Recent Claims That Triggered an FDA “Courtesy Letter”
Botanical producers need to be wary of crafting claims in their marketing and on their labels that would trigger drug regulation. When crafting structure/function claims, it is important not to mention specific diseases. For example, a botanical could claim to “support immunity,” a function of the body, but cannot claim to “boost the immune system against colds and the flu.” Claims that a botanical is “protective against the development of cancer” or “reduces the pain and stiffness associated with arthritis” would both be impermissible disease claims.
So, there is the basic principle: structure/function claims are allowed, so long as they are phrased specifically to avoid mention of any disease or symptom and include the FDA disclaimer! Botanical products can have nuanced benefits, and you want to be able to describe them specifically and accurately. Keep reading for more details.
2) Be Wary of the Line Between Permissible and Impermissible
The dividing line between permissible structure/function claims and impermissible disease claims can be tough to define. In some cases, it is clear why the FDA considered some of these disease claims. Usually, the FDA reacts to claims attempting to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases. A claim of this nature would put the product in the category of a ‘drug.’ And drugs require extensive premarket approval by the FDA. Sometimes, though, the FDA’s reasoning is less clear. In general, we can glean from the examples above that the FDA wants botanicals labeled as dietary supplements to be supportive of health but not used in treating diseases.
The mere implication of a disease claim can also trigger drug regulation. The claim that a supplement “improves joint mobility and reduces joint inflammation and pain” is in the ‘impermissible’ category above because the problems listed are considered to be the characteristic signs or symptoms of rheumatoid arthritis. Again, for a botanical claiming to “reduce cholesterol,” we run into the same problem. In this case, the implication is that the reduction is from high cholesterol, which is a symptom inextricably tied to cardiovascular disease.
What botanical producers can claim is that their product will “stimulate,” “maintain,” “support,” “regulate,” or “promote” normal (i.e., non-disease related) bodily structures or functions. They can also claim to impact states of the mind or body that don’t rise to the level of a diagnosable condition. This is why one can claim a botanical will “improve absentmindedness.” Even though one could argue that ‘absentmindedness’ is a characteristic symptom of Alzheimer’s disease, it doesn’t adequately describe the serious symptoms of that disease, nor is that symptom inextricably linked to Alzheimer’s.
See below for more examples of claims the FDA took issue with for various reasons. The claims are in bold, and the FDA’s reasoning for taking an enforcement action is spelled out below each statement.
- “Supports healthy blood cholesterol levels”
FDA’s Reasoning: Only “maintenance of normal cholesterol levels” is permissible as a structure/function claim; any other claim insinuates treatment of cardiovascular disease. - “D-Mannose to help flush unwanted microbes from the bladder.”
FDA’s Reasoning: This is an issue because the claim here implies that this dietary supplement treats urinary tract infections, as “unwanted microbes” in the bladder are very closely associated with UTIs. Furthermore, we know from FDA rules that the “terms ‘antibacterial,” “antimicrobial,” “antiseptic,” or “kills germs” all constitute implied drug claims that cause products described as such to be classified as drugs. - “CeDal is rich in natural ingredients that help in relieving symptoms related to cough and cold.”
FDA’s Reasoning: Cannot directly or indirectly reference diagnosable conditions, like a cold. - “Increased hydration & water balance”
FDA’s Reasoning: This one is interesting as the FDA isn’t claiming that this is a mislabeled drug, but that the way the product is labeled categorizes it as a food rather than a dietary supplement. Foods have different labeling and safety requirements than dietary supplements. - “May help to maintain skin health from UV radiation.”
FDA’s Reasoning: It may surprise you, but sunscreens are regulated as drugs in the United States, so mention of UV radiation or sun-protection claim means the product will be categorized as a drug. - “Supports a healthy response to inflammation” and “Supports the body’s healthy response to inflammation.”
FDA’s Reasoning: Inflammation is too closely linked with arthritis as a disease for it to be part of a structure/function claim on a dietary supplement.
3) What’s the Real Definition of a Structure/Function Claim?
Honestly, the legal definition of an allowable structure/function claim is rather confusing. As we’ve shown, a structure/function claim states how a botanical product impacts a bodily structure (i.e., bones) or function (i.e., digestion). The specific definition, though dense, can be helpful to have on hand. Permissible structure/function claims can state:
- The role of the botanical intended to affect a structure or function of the human body, or
- The means by which the botanical acts to maintain the structure or function, or
- That general well-being results from consumption of the botanical, or
- (Not very common for botanicals) That the botanical is beneficial for a classical nutrient deficiency disease (e.g., scurvy). In this case, the prevalence of such disease in the US must also be disclosed.
4) No Matter What, Make Sure Your Claim is Accurate!
You, the manufacturer, are responsible for the accuracy of any claims you make. This means, in the words of the FDA, that you must be able to “substantiate that the statement is truthful and not misleading.” And, as described above, even though there is no pre-approval, manufacturers must still share the text of the structure/function claim made on their products with the FDA no later than 30 days after the first time the product is marketed. The FDA typically only responds to this notification letter if they disagree with the nature of the claim you’ve made. In these cases, the FDA sends what they call a ‘courtesy letter.’ If there is no objection to a claim, the FDA will not respond.
It may be helpful to browse past FDA notifications for structure/function claims. This way, you can review what type of claims the FDA is flagging and see how other dietary supplement manufacturers are formatting their required 30-day notifications to the FDA. Go to www.regulations.gov. If you want to view claim notifications that the FDA took issue with, type “FDA-1997-S-0006” into the search box. For those that did not receive a response and therefore are presumably permissible, type “FDA-XXXX-S-0024” into the search box, replacing “XXXX” with “2023” or any other year you would like to search.
A Note on FDA Terminology for Structure/Function Claim Enforcement.
Notification Letter
Making structure/function health-related claims doesn’t require pre-approval by the FDA. However, you are required to “notify” the FDA about the claims. This means that no later than 30 days after first marketing the supplement, you must send a notification letter to the FDA, including the text of the structure/function claim you’ve made.Courtesy Letter
For structure/function claims, the FDA sends what they call a “courtesy letter.” These point out any claims that they have as issue with and give the company leeway to correct the problem. These are not the same as the enforcement level “warning letters” that we talk about later in this guide, and they are only relevant for structure/function claims on dietary supplements.Close Out Letter
If the company timely and adequately changes the labeling and marketing of the product, the FDA will issue a “close out letter” indicating that the issue has been resolved.
ii. Other Ingestible Botanicals Claims: Nutrient, Health & Qualified Health Claims
1) Nutrient Content Claims
There are other categories of claims that can be made for dietary supplements, but they are less relevant for botanical products. These claims are more often made for food products. We will briefly review them so that you are familiar with why their application is limited. We also want you to be familiar with them if you they were to become relevant to the products you make. First, we will tackle nutrient content claims. These are statements that characterize the level of a nutrient in a product.
Here are some words that characterize nutrient levels. Is it surprising to discover that some of these are regulated on food and dietary supplement labeling?
“HIGH” or “GOOD SOURCE”
Descriptive words, like the ones above, need a standard to be compared against so that consumers can have a useful shared understanding of what they mean. The FDA maintains these standards. To do this, the FDA regulates the use of the words above. Certain of these words or phrases, like “high” and “good source” can only be used for claims about nutrients that have established daily values (i.e., Reference Daily Intakes (RDIs) or Daily Reference Values (DRVs)). Nutrients, vitamins and minerals that have established RDIs are your Vitamins A, C, D, etc… or minerals like magnesium and iodine. See here for a full list. In those cases, the established daily values are used as the standard against which the products are compared to determine if they are, in fact, “high” in or a “good source” of a certain nutrient.
For nutrients that have no established daily values, any statement on the label or marketing materials must only specify the amount of nutrient per serving. Comparisons are only allowed if a reference—a reasonable object of the comparison—is clearly stated as well. For example, omega-3 fatty acids do not have an established daily value. Therefore, a dietary supplement label can only say “contains X grams of omega-3 fatty acids,” but cannot say “high in omega-3 fatty acids.” An acceptable sample comparative statement would be “twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg).”
“High potency” can only be used in the vitamin or mineral is present at 100% or more of the daily value per reference amount customarily consumed. You must clearly identify which vitamin or mineral you are describing.
“ANTIOXIDANT”
To use the term “antioxidant,” the nutrient must have scientifically recognized antioxidant activity. In addition, the level of the nutrient must be of a rate that would qualify for a “high” or “good source” claim. To say “high,” the supplement must contain 20% or more of the RDI for the nutrient. And, in order to say “good source,” the supplement must contain between 10 and 19% of the RDI. Therefore, a claim that the product is “high in antioxidant vitamin C,” the product must contain at least 20% of the daily RDI. Antioxidant claims that aren’t related to nutrients with an RDI are technically allowed as long as they are truthful and not misleading.
“FREE” or “LOW”
“Low” or “free” as descriptors are limited to products that are specially processed, altered or formulated to lower the amount of the nutrient in the food (usually sodium or fat) as compared to what is normally expected of that dietary supplement. Again, you can only label your product as “no sugar added” if sugars are normally expected to contain them. “Low sugar” is not permissible.
“HEALTHY”
“Healthy” is an implied nutrient content claim and cannot be used unless it describes a food that meets certain requirements for fat, saturated fat, cholesterol, vitamins and minerals.
“CONTAINS” or “PROVIDES”
Also be careful if you use the words “contains” or “provides,” as you must be specific about the amount if you use those words. Meaning, you cannot say “contains omega-3 fatty acids” without specifying the amount per serving.
As you will read about in the Labeling section of this guide, not all supplements are required to include a “Supplement Facts” panel on their packaging. However, if a nutrient content claim is made, then even exempt supplements must provide a Supplemental Facts panel on their label. Any nutrient without a Daily Value (DV) (i.e., botanicals) must be listed on the Supplement Facts panel with a footnote indicating “Daily Value Not Established.” See the Labeling section for more information.
2) Health Claims
All of these claims we’ve talked about up to this point could be described as ‘health claims.’ However, ‘health claims’ is a term of art used by the FDA with a very specific, and very restrictive meaning. In layperson terms, any of the structure/function claims we spent so long going over would be considered claims about ‘health.’ But, when the FDA uses the term health claims, it means specifically claims that have been pre-approved and are:
“explicit or implied characterization(s) of a relationship between a substance and a disease or health-related condition.”
There are only particular health claims that have been pre-authorized by the FDA, and all are supported by significant scientific agreement. A good example is “calcium may reduce the risk of osteoporosis.” See how, in this case, a specific disease can be mentioned? Even though in contrast to structure/function claims these statements can mention diseases, they still cannot claim to cure, mitigate, or treat the disease. There is an exclusive list of authorized health claims, and very few, in any, would be applicable to an herbal supplement.
3) Qualified Health Claims
There is one other type of claim possible: a qualified health claim. This type of claim can be supported by a lower standard of scientific evidence and is not pre-approved by the FDA. A claim of this type must be accompanied by a disclaimer. Manufacturers can petition the FDA to issue a Letter of Enforcement Discretion, which spells out the specific language the FDA believes reflects the current state of scientific evidence for the statement. For example, after extensive review, the FDA wrote that it would allow the following statement for a cranberry juice beverage, which is hardly a resounding endorsement, if all other requirements for the label were met:
“Limited and inconsistent scientific evidence shows that by consuming one serving (8 oz) each day of cranberry juice beverage, health women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.”
Qualified health claims will likely be more trouble than they are worth for a small botanical producer.
C. Claims for Topical Botanicals
If you are making a lip balm or salve that is not going to be taken internally, what claims can you make about your product’s benefits?
These types of products are regulated as cosmetics. Claims about the impact of topical botanical products have less leeway than ingestible botanical products—less can be said about their benefits in marketing! In contrast to dietary supplements, a topical botanical product cannot claim that it will affect any structure or function of the human body. Neither, of course, can any statements that indicate the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease be made.
A cosmetic doesn’t require the FDA disclaimer that dietary supplements do, because these health-related claims cannot be made at all!
When deciding what you can say on your topical botanical label, many of the same principles we’ve talked about still apply. For example, mentioning specific diseases or symptoms highly correlated with a disease will trigger drug regulation. Therefore, a face mask that claims to provide “restructuring and pain relief from acne or cystic acne” will result in an enforcement action from the FDA. See Table 3 below for more examples of impermissible claims for topical botanicals.
TABLE 3. Examples of Impermissible Claims Made by Topical Botanicals
You may recall from the Ingestible Botanicals section that sunscreens are always regulated as drugs. This means any sun protective claims will cause a cosmetic to be a misbranded drug. Another potentially surprising descriptor that is off the table is ‘antimicrobial.’ Even antiperspirants are regulated as drugs because of their antimicrobial nature. Topical botanicals with tea tree oil, for example, cannot be labeled as antimicrobial, no matter how effective we know them to be.
Just as an illustration of how tricky it can be to produce cosmetics, let’s think about shampoo for a moment. Generally, shampoos function to clean the hair. This clearly puts shampoo in the cosmetic camp. However, if a shampoo is an anti-dandruff shampoo, it becomes a drug because it is used to treat the medical condition of dandruff.
Claims to reduce or hide wrinkles are very popular, but they often can cross the line into making impermissible drug claims. In the past, products have claimed to increase collagen production as a means of reducing wrinkles. This conveys that the product impacts the structure of the body. And, as we stated above, a structure or function claim is impermissible for a topical botanical. Any product that claimed to help the skin produce collagen would need to be approved as either a drug or a medical device. However, topical botanicals can claim to make wrinkles less noticeable due to a moisturizing effect. A claim that indicates the product changes the face’s structure? Absolutely impermissible. But one that claims to moisturize the face? Completely permissible.
Another example, this time with a drastic outcome for the company, is a product that described itself as a “face lift without surgery.” The FDA seized all these products based on this claim. Even though it is unlikely a reasonable person would believe that their face would structurally morph to post-surgical-like results due to a product they apply to the skin, judges still upheld the seizure. Labeling laws, the court argued, must be made with the “ignorant, the unthinking and the credulous” in mind.
A second company, aware of the “face lift” drama, specifically said in their materials that their lotion was “not a face lift” but was “amazing,” “super-active,” “tightened the skin,” and “discouraging new wrinkles from forming.” This lotion was also seized. Here, the judges determined that the marketing, though full of “puffery,” still had strong therapeutic connotations, amounting to representing the cosmetic as a drug.
These examples emphasize that the test for how a product is regulated is not the physical effect it has on the user’s body (those lotions and creams could never have actually given a user a face lift) but, rather, what the label and promotional claims say about the intended uses and impacts. And the bar for topical botanicals is quite low—many claims are impermissible. Language is power in the cosmetic and dietary supplement world—you must understand the influence of the words you choose on what regulations are triggered.
A few more impermissible claims that might be relevant for botanical producers:
- Suggesting an aromatherapy product is an effective aid in quitting smoking, or
- Suggesting an aromatherapy product is an effective aid with sleeping, or
- Creams that claim to remove or reduce cellulite
are all impermissible as they suggest an intention to change the structure or function of the body or treat with diagnosable disease conditions (insomnia, addiction).
And, what happens if you create a topical botanical that the FDA determines to be a misbranded drug? If a drug is misclassified as a cosmetic by the manufacturer, the FDA sends a Warning Letter. You can see recent Warning Letters here. This is the first step in an FDA enforcement action and can be resolved quickly if labeling is changed and communication with the FDA is clear. However, an inspection is likely to follow a warning letter.
Action Steps for the Botanical Producer
What can botanical producers do to apply these concepts to their business models and marketing strategies? FDA’s regulations can seem complex and overwhelming. As a starting point, botanical producers can:
- Look closely at the labels and marketing for trusted dietary supplements and cosmetics and take note of the language used about their health-related impacts.
- Review FDA Courtesy Letters (letters sent to dietary supplement and cosmetic companies that have made claims the FDA considered impermissible) to get familiar with the types of claims the FDA takes issue with. Review the instructions on how to do this above, or start at www.regulations.gov and enter “FDA-1997-S-0006” into the search box.
- Talk to other botanical producers or join a group that can help provide support on marketing strategies and health-related claims.
Ultimately, botanical producers will need to implement the Action Step for this Chapter: adapt their marketing strategies so that any health-related claims are proper claims for dietary supplements or cosmetics.