The first part of any successful subscription campaign comes down to acquisition. How are customers finding out about your products and the benefits associated with them? For any consumer product company, especially those in the CBD and consumable space, you have to be careful about how you talk about your product.
That’s why we’re excited to have Nicholas Rossis, Editor-in-Chief at Insync Media, join us for a guest blog about how to write FDA-Compliant Copy on Your Website. Nicholas is a seasoned writer with a ton of experience in the CBD space. Here we go!
Writing FDA-compliant copy can be one of the greatest challenges facing promoters of CBD and nutritional supplements. The principles sound easy enough. In the FDA’s words, “Although the Food Policy Statement does not specifically refer to supplements, the principles underlying the FTC’s regulation of health claims in food advertising are relevant to the agency’s approach to health claims in supplement advertising.” [1]
The key regulatory principle you need to remember is that your copy is addressed to healthy people, not sick ones. From this basis flow all the guidelines you must adhere to and this is the ultimate litmus test for any question you may have regarding your copy.
This brief guide will identify the basic concepts you need to keep in mind.
Why Do We Need This?
You may wonder why FDA compliance is necessary, anyway. In May 2021, the Federal Trade Commission (FTC) acted against Kushly Industries LLC in its latest law enforcement action, the seventh to date, to halt deceptive health and efficacy claims in the growing market for cannabidiol (CBD) products. The company agreed not to make false or unsupported claims and paid a hefty fine in consumer redress.
Put simply, nuances in verbiage are important so that the FTC, as well as the FDA, do not initiate any enforcement action.
Rules regarding dietary supplements are detailed. Depending on the ingredients, different rules come into play. The FTC has overlapping jurisdiction with the federal Food and Drug Administration (FDA) and focuses more on whether advertising is truthful, or false and misleading. Thus, it is important to respect nuanced rules regarding dietary supplements.
Nuances in verbiage are important so that the FTC, as well as the FDA, do not initiate any enforcement action.
Dietary Supplements
The Dietary Health Safety and Education Act of 1994 (DSHEA) specifically defines a “dietary supplement” as a product taken by mouth that is intended to supplement the diet and that contains one or more of certain dietary ingredients [2]. The product must be labeled as a dietary supplement and must not be represented for use as a conventional food or as the sole item of a meal or the diet.
Lines can blur — for example, a bottled water drink containing vitamins, food additives, etc. The key regulatory impact of the DSHEA is that a product that meets the definition of a dietary supplement does not need FDA approval of safety and effectiveness before being marketed.
Dietary supplements are alternatively called nutritional supplements or food supplements. They are considered a special category of food and are not regulated by the FDA as drugs. CBD is a prime example of this.
Kinds of Claims
Express or Implied
There are several ways of categorizing claims. For example, claims may be expressed or implied. Interestingly enough, the FTC [3] warns advertisers that they should not focus just on individual phrases or statements, but rather should consider the ad as a whole, assessing the “net impression” conveyed by all elements of the ad, including the text, product name, and depictions.
Even implied claims need to be substantiated. For example, an ad for a CBD supplement called “Arthri-cure” claims that the product maintains joint health and mobility into old age. The copy features two images: the “before” picture shows an elderly woman using a walker. The “after” picture shows her dancing with her husband. The images and product name likely convey implied claims that the product is effective in the treatment of the symptoms of arthritis, and may also imply that the product can cure or mitigate the disease. The advertiser must be able to substantiate these implied claims.
Structure/Function Claims
The main kinds of claims we make in marketing are so-called structure/function claims. Following the FDA’s definition [4]:
- Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body. For example, “calcium builds strong bones.”
- Structure/function claims may also characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function. For example, “fiber maintains bowel regularity,” or “antioxidants maintain cell integrity.”
- Structure/function claims also include general well-being claims, which describe general well-being from the consumption of a nutrient or dietary ingredient.
- They also include nutrient deficiency disease claims, which describe a benefit related to a nutrient deficiency disease. For example, “vitamin C prevents scurvy.” Such claims are only allowed if they also say how widespread such a disease is in the United States.
If your copy or dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim. It’s usually best to place such a disclaimer at the footer of each page.
Generally speaking, structure/function claims are acceptable, whereas disease claims are not.
Disease Claims
According to the FDA [5], a statement is a disease claim if it mentions a specific disease or class of diseases. For example, a claim that a product is “protective against the development of cancer” or “reduces the pain and stiffness associated with arthritis” would be a disease claim.
A statement also is a disease claim if it implies that it has an effect on a specific disease or class of diseases by using descriptions of the disease state. Examples of implied disease claims are “relieves crushing chest pain” (which suggests angina), “improves joint mobility and reduces inflammation” (hinting at rheumatoid arthritis), or “relief of bronchospasm” (asthma).
Acceptable Disease Claims
While we try, as a rule, to avoid making any disease claims, disease claims are actually allowable if worded carefully. For example, an allowable disease claim for a CBD product would be:
“For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, strains, bruises, and sprains.”
The key above is that we’re describing temporary relief from an occasional condition that may afflict a healthy person.
You may also make general statements about health promotion and disease prevention as long as the statement doesn’t imply that your product can diagnose, cure, mitigate, treat, or prevent disease.
Also, some natural states or processes such as aging, menopause, and the menstrual cycle are not themselves diseases (of course, they can still be associated with abnormal conditions that are diseases).
So, stating that your CBD product addresses “mild memory loss associated with aging,” “non-cystic acne,” or “mild mood changes, cramps, and edema associated with the menstrual cycle” is acceptable structure/function claims. However, saying that it treats “Alzheimer’s disease or senile dementia in the elderly,” “cystic acne,” or “severe depression associated with the menstrual cycle” is making disease claims and is not permitted.
Unacceptable Disease Claims
In general, mentioning the name of a specific therapy, drug, or drug action will associate the claim with the intended use of the therapy, drug, or drug action and be a disease claim.
For the same reason, a claim that a product will affect adverse events associated with a therapy for a disease is a disease claim if the adverse event is itself a disease. For example, “CBD can be used to address nausea related to chemotherapy” is a disease claim.
“CBD can be used to address nausea related to chemotherapy” is a disease claim, which is unacceptable.
Health Claims
Acceptable health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease.
For example, an allowable health claim is, “Soluble fiber from foods such as Psyllium husk, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. One serving of this product supplies X grams of soluble fiber from psyllium necessary per day to have this effect.”
You may also make a qualified health claim. While health claims must meet the standard of Significant Scientific Agreement (SSA), certain qualified health claims are permissible based on less scientific evidence as long as the claims are qualified and do not mislead consumers.
For example, an allowable qualified health claim is, “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of this product provides X gram of EPA and DHA omega-3 fatty acids.”
Blends and Mixes
Special consideration should be given to products that mix various ingredients. While each individual compound’s effects may have been well-substantiated, you must still be careful with any claims about the final product as their combination may have significantly changed their properties and effects.
Substantiating Claims
The FTC typically requires claims about the efficacy or safety of dietary supplements to be supported with “competent and reliable scientific evidence.”
For the purpose of web copy, these can be links leading to studies, lab tests by the producer, etc.
Anecdotal Evidence
Anecdotal evidence about the individual experience of consumers is not sufficient to substantiate claims about the effects of a supplement.
When lacking proper substantiation, a copywriter may have to edit the copy accordingly. For example, a producer had asked us to say that “liquid supplements are absorbed faster than capsules and powders.” However, this lacked substantiation, so we changed this to “liquid supplements are absorbed fast by the body.”
Traditional Medicine
When it comes to products that have been used in traditional medicine, the FTC will look closely at consumer perceptions and specifically at whether consumers expect such claims to be backed by supporting scientific evidence. Advertising claims based solely on traditional use should be presented carefully to avoid the implication that the product has been scientifically evaluated for efficacy.
For example, imagine an herbal supplement making the following claim: “This ancient folklore remedy has been used for centuries by Native Americans to aid digestion.” The statement about traditional use is accurate and the supplement product is consistent with the formulation of the product as traditionally used. However, if, in the context of the copy, this statement suggests that there is scientific evidence demonstrating that the product is effective for aiding digestion, the advertiser would need to include a clear and prominent disclaimer about the absence of such evidence.
Words to Avoid and Substitutes
From the above, it should be clear that words matter—a lot. To avoid some common pitfalls, you may want to follow the rules of thumb below (not an exhaustive list, of course):
- It is best to avoid the following words: diagnose, cure, treat, prevent. Instead, prefer support, maintain, promote, stimulate, fend off, and ward off.
- When it comes to substantiation, it is best to avoid the word “proves,” as studies very rarely “prove” anything. Instead, prefer “suggest.”
- Natural is also best avoided. The FDA [6] has considered the term “natural” to mean that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food. A copywriter should only use it if the client can substantiate it.
- Organic is another word that should only be used with caution. The US Department of Agriculture (USDA) [7] states that produce can be called organic if it’s certified to have grown on soil that had no prohibited substances applied for three years prior to harvest. Prohibited substances include most synthetic fertilizers and pesticides. So, if a client wants to use the word “organic” to describe their product, they should carry an organic certification by the USDA.
- The simple verb, “can” is also a loaded term, as it implies a clear ability. “May” works better in most circumstances, as it is not as strong a word as “can.”
Words to avoid: diagnose, cure, treat, prevent. Instead, use: prefer support, maintain, promote, stimulate, fend off, and ward off.
Client Expectations
Managing client expectations in regards to copy can be tricky. Obviously, no client wants to attract the FDA/FTC’s attention. At the same time, some tend to be more willing to take risks with their claims than others.
To deal with this, here at InSync Media:
- We ask clients to rate their risk comfort level on a scale of 1-5, and strongly discourage them from going over risk level 3.
- We also have an outside compliance officer we refer to if needed.
- Additionally, we have a contract addendum that every client in this category must sign before we write FDA-compliant copy.
- Finally, we stress that the FDA/FTC’s rules apply to all marketing copy, from labels to hashtags, email marketing, social media, reviews made by customers, keywords we rank for, metadata, schema, etc. It is pointless to be meticulous in a client’s blog post, only to have their social media full of unsubstantiated claims.
Conclusion
Writing FDA-compliant copy can be tricky. The rules are not always clear and can be the subject of heated debate. Each client has a different level of risk they are comfortable with. And the FDA may well update its rules without a warning.
Having said all that, the guidelines are actually quite simple in principle:
- All claims need to be substantiated, whether expressed or implied.
- Structure/function claims are generally acceptable.
- Disease claims are not acceptable.
- Substantiation ideally requires published, peer-reviewed scientific research, not anecdotal evidence or traditional usage.
- If you find yourself in doubt, consult the FDA website and err on the side of caution.
- Above all, stick to the golden rule: supplements are aimed at healthy people who wish to remain healthy.
By following these, you can write a copy that is compelling and yet adheres to FDA and FTC’s rules.
Happy writing!
References
[1] https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry
[2] For the purposes of the DSHEA, dietary ingredients are: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance used to supplement the diet by increasing total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any ingredient intended above.
[3] https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry
[4] https://www.fda.gov/food/food-labeling-nutrition/structurefunction-claims
[5] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-structurefunction-claims (this is a must-read for any copywriter working on supplements copy)
[6] https://www.fda.gov/food/food-labeling-nutrition/use-term-natural-food-labeling
[7] https://www.usda.gov/media/blog/2012/03/22/organic-101-what-usda-organic-label-means
[8] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-structurefunction-claims
