For a video-based learning experience, watch our tutorial Botanical Product Regulations and Health Claims Rules(56min)

 

The Food and Drug Administration (FDA) regulates botanical products. How these products are regulated is based somewhat on their ingredients but mainly on how the manufacturer describes the product. Farmers processing botanical products must carefully consider the words they choose to represent and market their botanical products because using certain words will trigger certain regulations. For example, if farmers were to describe botanical products with words like “cure,” or “treat,” or mention how the product will “mitigate” or “prevent” the symptoms of a specific disease, then that product automatically becomes a “drug” in the eyes of the FDA. Unless that farmer complied with the expensive and demanding requirements for bringing a new drug to market, the FDA could prosecute that farmer for selling an unapproved or adulterated drug. Farmers need to learn to be discerning with their words and marketing choices to ensure compliance in this area of the law. This guide will lay out how to make legally resilient marketing choices for botanical products so that farmers can conduct business without running afoul of the FDA.  

To illustrate the power of word choice, let’s use an elderberry farmer as an example. This farmer is interested in doing several things with their elderberries and is concerned about how federal regulations will impact their plans. The farmer is considering keeping it simple and selling the unprocessed elderberries to customers who want to make their own elderberry products. However, the farmer has also considered processing the elderberries into jams, syrups, a salve, or dried elderberry capsules. For marketing purposes, the farmer wants their customers to know that their elderberry products support healthy immune system functioning. If the farmer were to put those words on the product labels, what regulatory category would these elderberry products fall into? Review the table below. This table shows the potential regulatory categories for the various elderberry products.  

TABLE 1. Potential Regulatory Categories for Various Elderberry Products”

Food

Dietary Supplement

Cosmetic

Drug

·        Unprocessed elderberries 

 

·        Elderberry jam 

 

·        Elderberry syrup 

 

·        Elderberry syrup

 

·        Dried elderberry capsules

 

·        Unprocessed elderberries 

 

·        Elderberry jam

 

·       Elderberry salve

 

·       Elderberry salve

·       Elderberry syrup 

·       Dried elderberry capsules 

·       Elderberry jam 

·       Unprocessed elderberries

Notice that certain elderberry products can fit into multiple regulatory categories! How can a jam be a drug? Or a syrup be either a food or a dietary supplement? What is going on here? The issue is what the producer says about the product – the same product can move between these regulatory categories simply as a result of using regulated language. Producers must carefully consider how they intend customers to use their products and what health-related claims they want to make about the product. Marketing claims entice customers to purchase, but they also determine how the FDA regulates the product. Marketing choices can transform elderberries from a food to a dietary supplement, a cosmetic, or even a drug!

Coming up in the guide is more information on those descriptive language choices. But it’s also important to note that the form of the botanical product also impacts its regulatory category. For example, a farmer cannot sell a capsule of powdered dried elderberries as a food product because that isn’t how we eat food! According to the legal definition of a dietary supplement, any product that is intended to be ingested in “the form of a… tablet, soft gel, capsule, powder, gelcap, liquid and [that] is not represented for use as a conventional food or a sole item of a meal of the diet” is, by default, a dietary supplement. Therefore, as soon as the elderberry producer dries, powders, and puts the product into a capsule what was a food has become a dietary supplement.

In fact, this same capsule of powdered dried elderberries could become a drug if the producer marketed it using language associated with a drug claim. All the producer would need to do to create a botanical drug product is to make a health-related claim that their elderberry capsules could diagnose, treat, cure, or prevent a disease. A claim such as “these elderberry capsules will prevent colds and the flu” would trigger regulation as a drug.

This example demonstrates the very real risk that producers who don’t know these rules and definitions could accidentally create a botanical dietary supplement or drug product. And chances are, if the producer did this unknowingly, they did not comply with the applicable regulations and could be subject to harmful consequences to their business.

For another example, let’s look at the slightly more complicated example of elderberry syrup. A producer could create an elderberry syrup that is marketed as a food, with a suggested use of pouring it over pancakes. On the other hand, this producer could take the more common route of creating an elderberry syrup that is intended to be consumed for its immune-supportive qualities by the tablespoonful. Either way, the resulting products would be very similar. The ingredients and processing techniques will be nearly identical. But, depending on how the producer describes the product, instructs the consumer to use the product, and what, if any, health-related claims are made about the product, the products will have very different outcomes regarding what regulations govern their production and marketing. If the label has a picture of pancakes on the label, both customers and the FDA would likely consider the syrup to be a food. If the label suggested taking the syrup by the tablespoonful to support immune system functioning, then the product would irrefutable be, at least, a dietary supplement. If the label claimed the syrup could diagnose, cure, treat, or prevent a disease, then the syrup would be considered a drug, and the producer would run into even more regulatory trouble. 

What Rules Apply to Each Classification?

Now that we’ve addressed that what is said about a product and the form the product comes in can dictate its regulatory category, let’s dig into the consequences of falling into one category or another. What impact will it have on a farmer if their product is regulated as a dietary supplement as opposed to a food? The chart below summarizes some differences.

TABLE 2. Rules Specific to Each Regulatory Category

 

Food

Dietary Supplements

Cosmetics

Drugs

What health-related claims can be made?

Very limited and based on certain nutrients

More expansive “structure/function” claims allowed – some of the impermissible claims might be a surprise so be sure to read that section!

No health-related or structure / function claims allowed

Can claim to treat, cure, mitigate, or prevent diseases

Is pre-market approval required?

No

No, but there are some post-market notification requirements

No, but current rules require some companies to register their business with regulators

Yes

Federal safety and processing regulations (i.e. the Current Good Manufacturing Practices, cGMPs)

Preventive Controls Rule (cGMPs for Human Food) unless the processing is allowed on-farm under the Produce Safety Rule (see the definition of ‘farm’)

Dietary Supplement cGMPs

Modernization of Cosmetics Regulation Act of 2022 (MoCRA) – cosmetics aren’t intended to be ingested, so their safety requirements are generally less burdensome

Drug cGMPs

First, let’s talk about health-related claims. These are statements like “this product supports healthy sleep.” In general, if a botanical producer wants to be able to make health-related claims, then they will need to follow the other dietary supplement regulations. The definition of “structure/function” claims is explained in detail below, as is what is permissible for cosmetic marketing and how to stay away from claiming a product can treat, cure, or prevent a disease. Often, botanical producers want to be able to tout the health-related benefits of their products and therefore, desire to be in the dietary supplement category.

This category, though, comes with other burdens! Thankfully, pre-market approval isn’t one of them. Pre-market approval is a process whereby the FDA must review and approve of a product before it can be sold anywhere. Dietary supplements don’t have this requirement, nor do foods or cosmetics. As is indicated in the chart, however, dietary supplements do have “post market” notification requirements. This means that in some cases, dietary supplement producers must notify the FDA of what health-related claims are being made about their products within a certain period of time after first selling their product. See Sidebar 2 in this Section to learn how to notify the FDA of a structure/function claim made for a dietary supplement.

Finally, there are Current Good Manufacturing Practices (cGMPs) for each regulatory category. These are extensive rules and guidelines on how to safely manufacture, pack, hold, and distribute products. Many farmers are already following food safety practices, but farmers that are working in botanical production may have to also follow cGMPs specific to dietary supplements. Food and dietary supplement cGMPs are similar, but dietary supplement cGMPs are largely considered to be the more challenging of the two. Furthermore, food safety education and technical support is more broadly available across the agricultural industry than dietary supplement production safety.

Now, back to the elderberry farmer. If the farmer wants to say their elderberry products support immune system functioning, then that farmer has placed themselves in the regulatory category of ‘dietary supplements’. After consideration, that farmer could decide that following dietary supplement marketing, production, and post-market notification rules is too difficult or expensive. In that case, the farmer could choose to only make syrups and jams that stay within the food regulatory category. Or the farmer could make a cosmetic salve that doesn’t make any health-related claims. Knowing the power of words in this area of law, the elderberry farmer will be very careful with how they describe their product, so they stay in the regulatory category they’ve chosen!

SIDEBAR 1. Specifically Regulated Botanical Ingredients

There are some specific botanical ingredients that have caught the eye of the FDA and have 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.

The full list is available in the FDA’s Dietary Supplement Ingredient Directory. This directory will change over time; it is recommended botanical producers check the directory from time to time.

Here are some botanical examples included in the directory:

Comfrey. Comfrey is a source of alkaloids; oral overconsumption of this botanical can lead to liver damage according to some studies. 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 for that use. Comfrey is now only legally sold 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.

KavaIn 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.

Structure/Function Claims for Dietary Supplements

If a botanical producer wants to market their products by describing how the product works on the body and the good things it will do for a customer’s health, then you want to be manufacturing dietary supplements. But making the wrong kind of claim can get you into hot water. How does a farmer know what they can and can’t say?

A Farmer’s Perspective: The Power of Words in Marketing

Alana markets her botanical products mostly as food, although she recognizes they are dual – food as medicine. This ethos guides her operation, where she grows herbs, creates a wide range of tea blends, and markets her products as food to avoid making claims. However, she can’t avoid folks asking for more information about her teas (what they’re good for, how to prepare them, how much to take), and she wants to share her wisdom and knowledge. Her primary concern is: How do I be mindful about what I’m saying and what my words mean in the eyes of the law?

Generally, the safest claims are called “structure /function” claims. These claims state how a botanical product impacts a bodily structure (i.e., bones) or function (i.e., digestion). Permissible structure/function claims can state one of the following:

  • The role of the botanical intended to affect a structure or function of the human body, or
  • How the botanical acts to maintain the structure or function, or
  • That general well-being results from consumption of the botanical.

These claims don’t require pre-approval by the FDA, meaning you can make them without waiting for the FDA to officially sign off on your marketing plan. However, a permissible claim cannot reference an actual disease and should avoid referencing commonly known symptoms of diseases. This is a challenge! However, if botanical producers don’t understand structure/function claim rules, they can draw the attention of FDA regulators. Here’s a quick summary of what not to do and what to do when crafting a compliant structure/function claim, which we’ll explore more in this section: 

Do not:

  •     Imply that the supplement can diagnose, treat, cure, or prevent any disease,
  • Mention any specific diseases in your claim, nor
  • Suggest the supplement relieves symptoms that are characteristic of a specific disease.

Do:

  • Describe the benefits as those that support the normal or healthy functioning of the body,
  • Notify the FDA of the claim you make within 30 days of marketing it (this is the post-market notification requirement), and
  • Include the following FDA disclaimer 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.”

This list seems straightforward, but what does this look like in practice? Examples will help illustrate the rules. 

Crafting Permissible Structure/Function Claims

The elderberry farmer who wants to market their elderberry syrup with the phrase “supports the body’s immune system” on the syrup’s label is allowed to do so under a few conditions. First, the FDA disclaimer (quoted above) must be included on the label. Secondly, the farmer would need to submit the claim to the FDA within 30 days of beginning to sell the elderberry syrup. (See Sidebar 2 for instructions on how to notify the FDA about a structure/function claim.) But what if a farmer makes St. John’s Work capsules and markets them with the phrase “treats mild to moderate depression”? Not permissible. Even if the farmer included the FDA disclaimer, the statement is impermissible for two reasons. First, because it specifically mentions a diagnosable condition–depression (the severity is not relevant here). Second, it claims it “treat,” which is something only drugs can do.

The table below compares permissible structure/function claims for a product with impermissible claims. These examples should help clarify what the FDA allows for dietary supplements. 

TABLE 3. Permissible and Impermissible Structure Function Claims

Permissible

Impermissible

“Antioxidants maintain cell integrity.”

“Antioxidants protect against the development

of cancer.”

“Improves absentmindedness”

“Protects against Alzheimer’s disease”

“Helps to maintain cholesterol levels that are already within the normal range.”

“Supports healthy blood cholesterol levels”

“Regulates mild mood changes, and cramps associated with the menstrual cycle.”

“Alleviates severe depression associated with the menstrual cycle.”

“Helps support cartilage and joint function”

“Improves joint mobility and reduces joint inflammation and pain”

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 a 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 to persuade customers of the product’s value. Unfortunately, the use of the “wrong” words can violate the regulations. Keep reading for assistance in how to craft permissible claims.

A Farmer’s Perspective: Addressing the Ambiguity of Permissible Structure/Function Claims

Andie found it difficult to enter a botanical market with only fresh herbs for sale. They brought all kinds of fresh herbs to the first few markets, and someone did buy 1lb of nettles, but otherwise, sales were low. They pivoted and started selling their dried tea blends and herbal vinegars instead. Customers were very interested and wanted direction on how to properly use the prepared products. Andie felt scared to provide this information because they wanted to be responsible, as it’s misleading to say an herb works one way for everybody. Rather than make generalized claims, they decided to share very general information about the herbs, focusing on culinary preparations (“Make this into an ice tea!”, “Try this in a stir fry!”), while clearly stating that every herb will impact everyone differently.

Impermissible Disease Claims by Mere Implication

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 the claims to be impermissible. In others, the reasoning is less clear. In general, we can glean from the examples above that the FDA allows botanical products labeled as dietary supplements to claim they support the body in maintaining health but not to claim they diagnose, prevent, cure, or treat 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 in the chart above because joint inflammation is considered to be a characteristic sign or symptom of rheumatoid arthritis. Similarly, a botanical product claiming to “reduce cholesterol” implies that the reduction is from high cholesterol, which is a symptom inextricably tied to cardiovascular disease. Thus, just naming a symptom characteristic of a disease implies that the product is claiming to treat, cure, or prevent a disease. And that, of course, is an impermissible drug claim. 

So, how should botanical producers talk about their products instead? Botanical producers can claim that their product will “stimulate,” “maintain,” “support,” “regulate,” or “promote” normal (i.e., non-disease related) bodily structures or functions. For example, “supports a healthy response to allergens” is permissible. Botanical products 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 most notable symptoms of that disease, nor is that symptom inextricably linked to Alzheimer’s.

Anyone reading this guide may be scratching their heads right now, wondering if they truly understand what makes a claim permissible or impermissible. The examples are not crystal clear, and there are ways to argue for the opposite conclusion for many of the findings. The main takeaway is to know that there are definite statements that are not allowed, and being on the safe side requires avoiding obvious violations and thinking hard about any gray-area statements. Further research into past FDA decisions can help in times of uncertainty.

How to Monitor FDA Decisions on Permissible Structure/Function Claims

One of the best things farmers can do to learn how to craft permissible structure/function claims for their products is to browse the FDA’s structure/function claim database. This publicly available resource holds all structure/function claims submitted by other dietary supplement manufacturers to the FDA. Also, it includes ‘courtesy letters’ the FDA sends when they disagree with the permissibility of a submitted structure/function claim. Not only can farmers start to understand requirements for the 30-day post-market notification of structure/function claims, but if they return to the website over time, they’ll start to see trends in what the FDA is paying attention to and enforcing. More importantly, it will give farmers many ideas on how to craft (and how not to craft) their own structure/function claims. Botanical business owners who make this a regular activity will help create marketing resiliency by staying ahead in the regulatory game.

 

SIDEBAR 2. Communication with the FDA about Dietary Supplements – Defining the Terms

30-Day Notification Letter

Botanical producers do not need FDA approval before making structure/function claims on their products. However, the FDA does require that businesses ‘notify’ them about any such claims. No later than 30 days after first marketing the dietary supplement, businesses must send a notification letter to the FDA, which includes the text of the structure/function claim you’ve made. Here is an FDA guide to submitting these notifications. Submitted notification letters are publicly available on the database described above. For examples of notification letters, follow the instructions below to “access structure/function claim notifications that other dietary supplement companies send to the FDA.”

Courtesy Letter

If the FDA finds an issue with a notification letter’s structure/function claim, they will reply to the notification letter with a “courtesy letter.” A courtesy letter will indicate which claims are impermissible and why. Businesses must alter the product’s label and advertisements to remove the impermissible health-related claims. The FDA requires a quick response to these letters. Do note that courtesy letters are not the same as warning letters, which indicate a higher level of enforcement. The Enforcement section of this guide addresses warning letters and other enforcement mechanisms. For examples of courtesy letters, follow the instructions below to “access FDA responses to impermissible structure/function claims.”

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 business resolved the issue. These will sometimes be attached to courtesy letters on the database referenced above.

To access structure/function claim notifications that other dietary supplement companies sent to the FDA: 

·       Step One: Go to www.regulations.gov.

·        Step Two: At the top of the page, there will be a search bar with grey text in the search bar that says, “Search for dockets and documents on agency actions.” One must enter a specific code into that search bar to find structure/function claim notifications. That code is FDA-2024-S-0024.

o   This code returns structure/function claim notifications from 2024. To search other years, replace the “2024” in the code with any year you would like to search.

·        Step Three: Click the link to choose from the products listed to see the company’s notifications. A button on the right will allow visitors to download the entire notification packet. Most notification packets include a cover sheet, a letter, and a copy or mock-up of the intended label and structure/function claims. Sometimes, under ‘content,’ the page will say no content is available. Scroll down to the “attachments” section to access the notification.  

Most of the time, the FDA does not respond to these notifications. The FDA won’t respond if they don’t see a problem with the claims made. However, there are plenty of times the FDA does respond with what is called a ‘courtesy letter,’ so there is plenty of material for botanical producers to study! See below on how to access courtesy letters on the FDA’s database.

To access FDA responses to impermissible structure/function claims:

  • Step One: Go to www.regulations.gov.
  • Step Two: At the top of the page, there will be a search bar with grey text in the search bar that says, “Search for dockets and documents on agency actions.” To find courtesy letters, one must enter a specific code into the search bar. The code is FDA-1997-S-0006.
    • This code returns all courtesy letters; one does not need to change this search term by year. Once results are returned, there will be an option to filter or refine the search by dates on the left-hand side of the page.
  • Step Three: Click on a courtesy letter result to be taken to the page to download the FDA’s courtesy letter. Sometimes, a ‘close-out letter’ indicating the matter was resolved will also be available.

Unfortunately, courtesy letters do not always explain the FDA’s reasoning for finding an issue with a particular structure/function claim. Often, the reader will need to extrapolate the FDA’s reasoning on their own. Though frustrating, this can be a helpful exercise. Understanding why the FDA has an issue with a particular claim will help producers understand the contours of permissible structure/function claims.

See the next table for some recently flagged structure/function claims from the FDA that illustrate the general guidelines we’ve laid out above. Remember that usually, the FDA reacts to claims attempting to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases. Such a claim would automatically categorize the product as a drug, no matter the ingredients or composition. Implying that a product is a treatment for a disease is also an issue, as indicated by three of the examples in the following table. The FDA also sends courtesy letters if a food has been mislabeled as a dietary supplement as happened to one company whose claim is listed in Table 4.

Review the table and reflect: are you surprised by some of these? Do you understand the reasoning behind the courtesy letter being issued? Will following the instructions above and reviewing more of these letters help you better understand the limits of what structure/function claims can be made?

TABLE 4. Recent Claims That Triggered an FDA “Courtesy Letter”          

“Supports healthy blood cholesterol levels.”

·        Why this claim is impermissible: This is a tricky one! “Supports” is usually a good verb choice for structure/function claims. However, mentioning cholesterol levels changes the analysis in this case because of the close link to cardiovascular disease. Any cholesterol maintenance claim MUST clarify that the product only maintains cholesterol levels already within the normal range. “Maintenance of normal cholesterol levels” is an acceptable alternative.

“D-Mannose to help flush unwanted microbes from the bladder.”

·        Why this claim is impermissible: 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.” 

·        Why this claim is impermissible: Businesses cannot directly or indirectly reference diagnosable conditions, even a cold.

 “Increased hydration & water balance.

·        Why this claim is impermissible: This one is interesting as the FDA isn’t claiming that this is a mislabeled drug, but 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.” 

·        Why this claim is impermissible: It may surprise you, but sunscreens are regulated as a drug in the United States. So, mentioning UV radiation or sun protection claims means the product will be categorized as a drug.

“Supports a healthy response to inflammation” and “Supports the body’s health response to inflammation.” 

·        Why this claim is impermissible: Inflammation is too closely linked with arthritis as a disease to be part of a structure/function claim on a dietary supplement.

Short Checklist for Structure/Function Claims

Craft a structure/function claim that doesn’t violate FDA’s regulations by following the guidelines stated above and by researching the FDA’s recent responses to structure/function notifications. Examining similar botanical products at retail stores and talking with peers can also help producers craft legally resilient structure/function claims!

Regardless of the nuanced discussion about word choice, producers must also ensure their structure/function claims are accurate! Manufacturers are solely responsible for the accuracy of any claims they make. In the words of the FDA, a producer must be able to “substantiate that the statement is truthful and not misleading.” Know and keep on hand trusted sources that can back up any structure/function claims you make, like scientific studies, herbal books, and evidence of traditional use of the botanical for the outcome you’ve claimed. These resources do not need to be posted anywhere. They only need to be readily available if the FDA asks for substantiation of a health-related claim.

Any structure/function claim must be accompanied by the FDA disclaimer: “This [or these] statement[s] have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” See the labeling section for more information and rules for placing this disclaimer on the label.

Notify the FDA of your intended structure/function claim within thirty (30) days of putting the product up for sale. See Sidebar 2 above for instructions on how to do this.

Other Health-Related Claims for Botanicals Classified as Dietary Supplements: Nutrient, Health, and Qualified Health Claims

Structure/function claims are the most common type of health-related claims for botanical products, but they aren’t the only option! The following claims aren’t as common for botanical products as for conventional foods or non-botanical-based dietary supplements. Though their application is limited in this context, some concepts discussed below will be relevant to a number of botanical businesses.

Nutrient Content Claims

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”

“good source”

“more”

“high potency”

“healthy”

“antioxidant”

“free”

“low sugar”

“less”

“excellent source”

 “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. Part of that maintenance is regulated the words and phrases listed 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 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 particular 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 also clearly stated.  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).”

To say “high,” the supplement must contain 20% or more of the RDI for the nutrient. And, to say “good source,” the supplement must contain between 10 and 19% of the RDI. “High potency” can only be used when 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.

To say “high,” the supplement must contain 20% or more of the RDI for the nutrient. And, to say “good source,” the supplement must contain between 10 and 19% of the RDI. “High potency” can only be used when the vitamin or mineral is present at 100% or more of the daily value per reference amount customarily consumed. Producers must clearly identify which vitamins or minerals they are describing.

 “ANTIOXIDANT”

To use the term “antioxidant,” the nutrient in the claim must have scientifically recognized antioxidant activity. In addition, the nutrient level must be of a rate that would qualify for a “high” or “good source” claim (described above). Vitamin C is a nutrient scientifically recognized as having antioxidant activity. But, to claim on a product’s label that it is “high in the antioxidant Vitamin C,” the product must contain at least 20% of the daily RDI for Vitamin C. Botanical producers cannot usually verify how much of a single nutrient is in a botanical product.

 “FREE” or “LOW”

“Low” or “free” as descriptors related to nutrients 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 generally expected of that dietary supplement. For example, you can only label your product as “no sugar added” if it is reasonable to assume that sugars may have been added to the product in question.

 “CONTAINS” or “PROVIDES”

To use the words “contains” or “provides,” the label must be specific about the amount of the nutrient per serving. Thus, a label cannot say “contains omega-3 fatty acids” without specifying the amount of omega-3 fatty acids per serving.

Health Claims

In layperson’s terms, all claims discussed above could be considered ‘health claims’ because they make a person think about health. However, the specific phrase “health claims” is a term of art used by the FDA with a very specific and restrictive meaning. When the FDA uses the term health claims, it means specific pre-approved claims that are an “explicit or implied characterization(s) of a relationship between a substance and a disease or health-related condition.”

 The pre-authorized health claims list is short. All pre-approved health claims have been supported by significant scientific agreement. A good example is “calcium may reduce the risk of osteoporosis.” When using such a pre-approved health claim, a specific disease can be mentioned (in contrast to structure/function claims). However, these statements still cannot claim to cure, mitigate, or treat the disease (because that would make them a drug). It is worth noting that very few, in any, of these pre-approved health claims would apply to a botanical herbal supplement. See this FDA link and this link for a comprehensive approach to finding pre-approved health claims.

Qualified Health Claims

There is one final possible type of claim: a qualified health claim. Compared to the health claims discussed above, a lower standard of scientific evidence can support this claim, but the FDA must pre-approve the language. Manufacturers interested in making a qualified health claim should visit this site and review the approved “‘letters of enforcement discretion”’ and “‘letters of denial.”’ to learn how the FDA makes its decisions and what has already been approved.  Manufacturers may also petition the FDA to consider new qualified health claims – see the same link as above. If the FDA agrees with the petition, it will spell out the specific language it believes reflects the current state of scientific evidence for the qualified health claim. These approved qualified health claim statements always include strong qualifications. The specific qualifying language depends on how strong the FDA considers the scientific evidence for the claim. 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:

“Limited and inconsistent scientific evidence shows that by consuming one serving (8 oz) each day of cranberry juice beverage, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.”

Given the narrow focus of these claims and the amount of effort and cost it takes to get them approved, qualified health claims will likely be more trouble than they are worth for a small botanical producer. 

Cosmetics: Health-Related Claims for Topical Botanicals

What about the producers making topical botanical products, like lip balm or salve? What claims can producers make about their product’s benefits?

 Topical botanical products can only be regulated as cosmetics or as drugs. The other regulatory categories–conventional foods and dietary supplements–are both ingestible foods. Botanical producers have less freedom and flexibility in making claims about topical botanicals than they do with ingestible botanical products. In contrast to dietary supplements, for example, a topical botanical product cannot claim that it will affect any structure or function of the human body. Cosmetics, furthermore, do not require the FDA disclaimer often seen on dietary supplements because that disclaimer is for structure/function claims and those claims aren’t allowed at all for cosmetics! And, to avoid being classified as a drug, the cosmetic claims cannot indicate the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

 A quick summary of how to market cosmetics in relation to what impacts the topical botanical will have on its user:

 Do not:

·        Imply that the cosmetic can treat, mitigate, cure, or prevent any disease,

·        Mention any specific diseases in your claim,

·        Suggest the cosmetic relives symptoms that are characteristic of a specific disease,

·        Claim the topical botanical would impact a structure or function of the body, or

·        Claim your cosmetic is sun-protective (more on this below).

Do

·        Describe benefits as cleansing, beautifying, moisturizing, or something similar that is appropriate to the product.

 Botanical producers deciding what to say on their labels can apply many of the principles already covered in this guide. For example, mentioning specific diseases or symptoms highly correlated with a disease will, once again, 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 5. Examples of Impermissible Claims Made for Topical Botanicals

Topical Product

Impermissible Claim

Face Cream

“Formulated with SPF containing oils, it provides…sun protection.”

Body Cream

 “The anti-inflammatory herb blend…can help with Arthritis, tendonitis, bursitis…”

Roll-On Oil

“Opens airways & alleviates…allergies.”

Night Face Oil

“Chamomile essential oil is packed with azulene, a powerful anti-inflammatory agent, for diminished scars and redness…”

Kojic Acid Cream

“To lighten…& even skin tone”

Restrictions on marketing for topical botanicals can be confusing and frustrating in their limitations. The U.S. is unique in regulating sunscreens 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 for topical botanical producers is “‘antimicrobial.” Stating that a product kills or prevents microbial growth or activity is considered a drug claim. 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.

To illustrate how tricky it can be to produce and market cosmetics, consider shampoo. Generally, shampoos function to clean hair. Their intended use and topical nature clearly puts shampoo in the cosmetic camp. However, some shampoos are marketed as having anti-dandruff properties. Since the FDA considers dandruff to be a medical condition, this type of claim on a shampoo would make it fall into the drug regulatory category. 

Claims to reduce or hide wrinkles are very popular for cosmetics, but they often can cross the line into making impermissible drug claims. For example, some products have claimed to increase collagen production to reduce wrinkles. A claim that a product can build collagen is a claim that the product impacts the structure of the body. As stated above, a structure/function claim is impermissible for a topical botanical. To make such a claim, a topical product that claimed to help the skin produce collagen would have to be pre-approved as a drug. However, topical botanicals can claim to be moisturizing and claim that the moisturizing effect makes wrinkles less noticeable.

Another example, this one from a real experience that had a drastic outcome for the company, is about a face cream that described itself as a “facelift without surgery.” The FDA seized these products as misbranded drugs 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 because the standards of the labeling laws were not based on what a “reasonable person” would think. Labeling laws, the court explained, must be made with the “ignorant, the unthinking, and the credulous” in mind.

Another company, aware of the “facelift” drama, specifically said in their materials that their lotion was “not a facelift” but was “amazing,” “super-active,” “tightened the skin,” and “discourag[ed] new wrinkles from forming.” This lotion was also seized. In that case, 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 facelift) but, rather, what the label and promotional claims say about the intended uses and impacts. And the bar for topical botanicals is quite high—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 topical botanical producers will want to remember:

  • Suggesting an aromatherapy product is an effective aid in quitting smoking,
  • Suggesting an aromatherapy product is an effective aid with sleeping, and
  • Creams that claim to remove or reduce cellulite.

All of those claims are impermissible as they suggest an intention to change the structure or function of the body or treat diagnosable disease conditions. The first claim implies the cosmetic can cure an addiction, whereas the second claim suggests it can cure insomnia, and the last one claims that it can impact a structure of the body–skin composition. None of these are permissible for topical botanicals.

The test for how a product is regulated is not the physical effect it has on the user’s body, but, rather, what the label and promotional claims say about the intended uses and impacts.

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. See the section on enforcement below, for more discussion.