Supplement Copywriting Guidelines: Navigate FDA and FTC Regulations

In the ever-expanding world of selling supplements, the art of crafting persuasive copy and marketing content is more critical than ever. However, a delicate balance must be struck between promoting your products and adhering to the strict regulations imposed by the FDA (Food and Drug Administration) and FTC (Federal Trade Commission).

I am Pat Dougherty, the Natural Health Writer. In this comprehensive guide, I will delve into nutritional supplement copywriting guidelines and best practices for ensuring compliance while maximizing sales.

I’ve been writing compliant, sales-driving supplement copy for 20+ years, with zero warning letters from the FDA.

I am sharing this guide on supplement copywriting guidelines to improve compliance for everybody — because compliance is great for both the supplement industry and the consumers who take supplements! Let’s get to it.

Dietary supplement copywriting requires a delicate balance between persuasiveness and compliance with stringent regulations.

When crafting copy for nutritional supplements, it is essential to prioritize accuracy, transparency, and truthfulness.

Start by thoroughly researching and understanding the specific ingredients in your dietary supplement product and their benefits that are backed by scientific research.

Avoid making unsubstantiated health claims or suggesting that dietary supplements can treat, cure, or prevent any disease. Instead, focus on structure-function claims that describe the intended role of the supplement in affecting the normal structure or function of the body.

Use clear and concise language, supported by credible scientific evidence, to communicate the product’s benefits to consumers. Additionally, always include appropriate disclaimers to clarify the claims limitation of nutritional supplements.

By adhering to these guidelines, dietary supplement copywriting can effectively inform and engage consumers while ensuring compliance with FDA and FTC regulations.

Understanding Structure-Function Claims

Before delving into the intricacies of supplement copywriting guidelines, it’s vital to grasp the concept of structure-function claims.

These claims describe the intended role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body. While structure-function claims are permissible, they must meet stringent criteria laid out by regulatory agencies to prevent misleading consumers.

In the nutritional supplement industry, structure-function claims refer to statements or assertions made about the intended role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body.

These claims describe the general physiological impact of a particular substance on the body’s structure, systems, or functions, without specifically stating that the product can diagnose, treat, cure, or prevent any disease.

Structure-function claims are distinct from health claims and disease claims.

While health claims specifically link a nutrient or dietary ingredient to a reduced risk of a specific disease or health condition, structure-function claims do not make such disease-related associations. Instead, they focus on more general benefits, such as supporting healthy joints, promoting digestive well-being, or enhancing immune system function.

It is essential to note that structure-function claims must be truthful and not misleading.

Additionally, dietary supplement manufacturers are responsible for ensuring that these claims are substantiated by scientific evidence, and they must comply with FDA regulations to avoid making false or deceptive statements about their products.

Here is a list of compliant structure-function claims commonly used in the dietary supplement industry. These examples emphasize the intended roles of dietary ingredients with careful words, without suggesting disease treatment, cure, or prevention:

“Supports joint flexibility and mobility.”
“Promotes healthy bone density.”
“Helps maintain healthy digestion.”
“Supports the body’s natural detoxification processes.”
“Aids in maintaining healthy skin and hair.”
“Assists in maintaining a healthy heart.”
“Promotes cognitive function and mental clarity.”
“Supports the body’s natural energy production.”
“Helps maintain healthy immune system function.”
“Promotes a sense of relaxation and emotional well-being.”
“Supports healthy weight management when combined with a balanced diet and exercise.”
“Helps maintain healthy blood sugar levels already within the normal range.”
“Assists in maintaining healthy cholesterol levels already within the normal range.”
“Supports healthy eyesight and visual function.”
“Aids in maintaining healthy liver function.”
“Supports cardiovascular health.”
“Promotes optimal muscle recovery after exercise.”
“Assists in maintaining healthy respiratory function.”
“Supports overall health and well-being.”
“Helps to maintain healthy cognitive function.”

Always ensure that your supplement product claims are truthful and not misleading, and consult with legal and regulatory experts to confirm compliance with FDA and FTC regulations in your specific case.

Did you know? If you plan on selling on Amazon, you need high quality and compliant content that mirrors the standards set by the FDA and FTC. Read my article on writing for Amazon Compliance.

Note: It is important to stay compliant with blog posts, too. Please read my article SEO Copywriter for Dietary Supplements to learn more about compliant content marketing that draws lots of organic search traffic.

The Dietary Supplement Health and Education Act (DSHEA)

The Dietary Supplement Health and Education Act (DSHEA) is a federal law in the United States that was enacted in 1994. DSHEA established regulations governing dietary supplements and created a framework for their oversight by the Food and Drug Administration (FDA).

I’ve written a LOT about DSHEA over the years, and like to think I’ve helped keep this legislation strong and viable. Here are some key provisions and objectives of DSHEA to keep in mind:

Definition of Dietary Supplements: DSHEA defines dietary supplements as products intended to supplement the diet, containing one or more dietary ingredients, such as vitamins, minerals, herbs, botanicals, amino acids, or other substances. These products can come in various forms, including pills, capsules, tablets, liquids, and powders.

Safety and Labeling: DSHEA requires dietary supplement manufacturers to ensure that their products are safe and accurately labeled. Manufacturers must provide accurate ingredient lists and nutrition labeling, and they are responsible for evaluating the safety of their products before marketing them.

Structure-Function Claims: DSHEA permits dietary supplement manufacturers to make structure-function claims that describe the intended effects of the product on the body’s structure or function, as long as these claims are truthful and not misleading. However, disease claims, which imply the treatment, cure, or prevention of specific diseases, are prohibited.

New Dietary Ingredient Notification (NDIN): DSHEA mandates that dietary supplement manufacturers must notify the FDA of the use of any new dietary ingredient (i.e., an ingredient not marketed in the United States before October 15, 1994) at least 75 days before marketing it. This notification allows the FDA to assess the safety of the ingredient.

Adverse Event Reporting: DSHEA requires manufacturers to submit reports of serious adverse events associated with their dietary supplements to the FDA. This helps the FDA monitor the safety of these products.

Good Manufacturing Practices (GMPs): DSHEA directed the FDA to establish regulations for current Good Manufacturing Practices (cGMPs) for dietary supplements. These regulations outline quality control standards for dietary supplement manufacturing, ensuring the consistent quality of products.

Exemptions: DSHEA provides exemptions for certain dietary ingredients that were marketed before DSHEA’s passage. These ingredients do not require NDINs but are still subject to safety and labeling requirements.

DSHEA aimed to strike a balance between consumer access to dietary supplements and the FDA’s ability to ensure their safety and efficacy. While it allows for a wide variety of dietary supplements to be available to consumers, it also imposes regulatory oversight to protect public health and safety.

I always say, if you want to hire the best supplement copywriter for your marketing initiatives, ask them about DSHEA in the interview. If they can’t answer, then move on!

The Risks of Making Supplement Health Claims

One of the gravest errors in supplement copywriting is making unsubstantiated health claims about your products.

If you’re learning about supplement copywriting guidelines, know that the FDA and FTC rigorously scrutinize this aspect, and any false or exaggerated health claims or inflated claims of effectiveness can lead to dire consequences.

It is an absolute prohibition to suggest that a dietary supplement can prevent, treat, or cure any disease.

Your claims should always be grounded in scientific evidence and adhere to stringent guidelines to maintain integrity.

If a dietary supplement company makes disease claims about their product, it can lead to serious regulatory and legal consequences. Making disease claims implies that a supplement can diagnose, treat, cure, or prevent a specific disease, which is strictly regulated by the FDA (Food and Drug Administration) in the United States. Here are some potential outcomes and repercussions:

FDA Warning Letters: The FDA may issue warning letters to the company, which serve as official notices of non-compliance with regulatory standards. These letters outline specific infractions and demand corrective actions, typically within 30 days. Ignoring or responding inadequately to these letters can result in more severe consequences. It is imperative to treat FDA warning letters with utmost seriousness and rectify the issues promptly.
Product Seizure: In egregious cases, the FDA has the authority to seize dietary supplements that make unapproved disease claims. This can result in financial losses for the company and damage to its reputation.
Legal Actions: The company may face legal actions, including fines and penalties, initiated by federal or state authorities. Class-action lawsuits by consumers who believe they were misled by the disease claims are also possible.
Product Recalls: In severe instances of non-compliance, the FDA may require product recalls to protect public health. This can be costly and damaging to the company’s brand.
Reputation Damage: Making unverified disease claims can severely harm a company’s reputation and erode consumer trust. Negative publicity and consumer backlash are common consequences.

Complying with FDA and FTC regulations is essential to maintaining both legal and ethical standards in the dietary supplement industry.

Navigating Special Sensitivity Categories

While it’s important to stay respectful to the FDA and follow supplement copywriting guidelines across all products, I have noticed that certain supplement categories require heightened vigilance due to their profound impact on health. These categories encompass:

Inflammation – Do not talk about anything being anti-inflammatory. It is better to put this in the context of immune modulation, if anything.
Pain – It is better to talk about soothing comfort than to talk about pain relief. That market is cornered by OTC and Big Pharma.
Immune boosting – This category has always been sensitive. Since COVID, it’s now 10X more sensitive than ever before. Immune support requires special care. I have expertise as an immune supplement copywriter.
Cholesterol lowering – Extremely sensitive since a red yeast rice debacle about 20 years ago. Maybe your product can help to maintain healthy cholesterol levels already within normal range. Maybe.
Blood pressure reduction – Similar to cholesterol in the cardiovascular wellness sphere; maybe your product can help to maintain blood pressure that’s already within normal range, but if you claim to help lower blood pressure, you are asking for trouble.
Testosterone boosting – Testosterone supplements can be effective, but this remains a rather controversial and risky category when it comes to claims. You can read more about testosterone supplement copywriting here.
Weight loss – unfortunately this category has a lot of unscrupulous companies seeking to capitalize on a near-universal consumer desire: to lose weight. If you sell weight loss supplements, take extra care in your claims. Click to read my blog article on weight loss supplement copywriting.

When marketing products in these categories, exercise extreme caution and ensure that every claim is solidly backed by scientific evidence. Avoid any form of exaggeration or unsupported assertions that could attract unwanted regulatory attention.

Special note on cancer: You should never, ever market a product for cancer. It is probably the biggest red flag the FDA will look for, and believe me, they will come down on your company HARD if you cross that line. Just don’t do it! It is irresponsible and a disservice to both consumers and the supplement industry as a whole.

What about FDA Qualified Health Claims?

FDA-qualified health claims for dietary supplements are specific statements or claims made on the labels or in the marketing materials of dietary supplements that have undergone a thorough review and evaluation by the Food and Drug Administration (FDA). These claims are permitted by the FDA based on scientific evidence supporting the relationship between a specific nutrient or dietary ingredient and a particular health benefit.

Qualified health claims differ from standard structure-function claims because they provide a more specific and scientifically substantiated statement about the potential health benefits of a dietary supplement. However, it’s important to note that qualified health claims are allowed under certain conditions and may include qualifying language or disclaimers to ensure that consumers receive accurate and balanced information.

To qualify for FDA-qualified health claims, dietary supplement manufacturers must submit a petition to the FDA, along with scientific evidence supporting the claim’s validity. The FDA then reviews the scientific data and evaluates whether there is enough evidence to support the claim without being misleading.

If the claim is approved, the FDA specifies the exact wording that must be used, including any necessary disclaimers, to ensure that consumers receive clear and accurate information about the potential health benefit.

Here is a list of some FDA-qualified health claims for dietary supplements, along with the corresponding nutrients or dietary ingredients:

“Calcium and vitamin D may reduce the risk of osteoporosis.”
“Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.”
“Folic acid may reduce the risk of neural tube birth defects when taken before pregnancy and during early pregnancy.”
“Phytosterols may reduce the risk of heart disease when consumed as part of a diet low in saturated fat and cholesterol.”
“Soluble fiber from certain foods and supplements may reduce the risk of heart disease.”
“Consumption of cranberry products may reduce the risk of recurrent urinary tract infections in healthy women.”

Please note that these qualified health claims are subject to specific wording and may require additional disclaimers or conditions as outlined by the FDA. Model claims are hard to come by, but worth it.

Dietary supplement manufacturers must adhere to these precise statements and follow FDA guidelines to make these claims on their product labels and marketing materials.

Additionally, new qualified health claims may be approved over time as new scientific evidence emerges and is reviewed by the FDA.

Supplement Copywriting Guidelines: Mistakes to Avoid!

Never mention diseases.

This goes beyond cancer. As soon as you mention a disease in the context of your supplement, you are violating all sorts of regulations. Just don’t do it. You can instead dance around diseases and conditions by alluding to them in a vague way that will remain respectful to the FDA and FTC. One example would be to talk about “mild and occasional joint discomfort” rather than directly talking about osteoarthritis.

Never go into PTC: Prevent, Treat and Cure.

I recently saw immune supplement marketing that talked about preventing and curing sickness. Yikes! I almost had a heart attack. It’s risky enough that to use” prevent” and “cure”, but to put it in the context of an extremely sensitive category these days — immune function — amplifies the risk significantly.

Never be deceptive or misleading.

The FDA and FTC want you to be “truthful and not misleading.” It is a reasonable request. But so many companies ignore this simple ask, raising their risk of landing on regulatory bodies’ radar. I have an example: I recently saw some multivitamin copy that said 95% of Americans are facing serious health problems due to essential nutrient deficiencies. This is inaccurate. A closer estimate is up to 10% of Americans are deficient in an essential nutrient.

The USA is a first-world country where enriched and fortified foods are widely available, and malnutrition is extremely rare. So how might the USDA, FDA and FTC react to marketing suggesting most Americans have nutritionally deficiency-? All would regard this as “untruthful and misleading,” potentially placing a company squarely in their crosshairs.

Never mention drugs.

The DSHEA act we discussed earlier established that supplements and drugs are completely different. Pharmaceuticals require extensive research prior to entering the market, but you can sell supplements right away. This distinction enables the supplement industry to exist and survive! Therefore, it is critically important to never mention a drug, never propose a supplement is an alternative to a drug, and never compare a supplement to a drug in your copy.

Strategies to Maintain Compliance

To write FDA compliant copy and stay respectful to FTC regulations while optimizing sales and brand reputation, consider implementing the following strategies:

Prioritize Transparency: Ensure that the key benefit (or benefits) of your supplement is communicated transparently and without exaggeration. All claims must be substantiated by credible scientific evidence. Anecdotal evidence will not cut it.

Employ Proper Disclaimers: Incorporate disclaimers when necessary to clarify the limited scope of your product’s claims. Emphasize that your product is not intended to diagnose, treat, cure, or prevent any disease.

Seek Expert Legal Guidance: Consult legal and regulatory experts who specialize in the dietary supplement industry to navigate complex regulations effectively.

Vigilantly Monitor Marketing Copy and other Materials: Regularly review and update your marketing materials to align with the latest regulatory guidelines. Stay abreast of industry changes and adapt your messaging accordingly.

Engage Professional Copywriters: If you’re running a supplement business, you already know it’s hard to write your own copy without experience. Consider hiring experienced dietary supplement copywriters who are well-versed in FDA and FTC regulations. Professional copywriters can help create persuasive, compliant marketing materials.

Get your guidelines straight from the source: The FDA and FTC have lots of useful information on this topic.

Hire me, the Natural Health Writer: I am a dietary supplement marketing expert with 20+ years of experience and zero FDA warning letters!

Stay Clean & Compliant Across the Board.

I cannot substantiate this, but over 20+ years, and especially recently, I have noticed that companies who get FDA warning letters have violations that extend beyond copy. For example:

if they do not adhere to Good Manufacturing Practices (GMP);
if they have adulterated supplements or undeclared ingredients;
if their labels are riddled with errors and missing key information…

Basically, if you have one violation, it seems like you increase risk of getting busted for multiple violations. The best answer is to pay close attention to quality. Be meticulous about your supplement marketing, manufacturing, content… everything. Be respectful to the consumers and the regulatory bodies that protect them.

Conclusion

In the dynamic dietary supplement industry, compliance with FDA and FTC regulations is non-negotiable. Violations can lead to severe repercussions for your business.

Nevertheless, with meticulous attention to detail, commitment to transparency, and accuracy, you can develop compelling sales copy and marketing content that both enhances your sales and build trust with your customers.

If you seek assistance in maintaining your product marketing and claims within the confines of regulations while optimizing sales, I am a seasoned dietary supplement copywriter, at your service.

I have expertise in direct mail & direct response marketing, web copy, ad copy, supplement labeling, unique selling proposition creation, dietary supplement blogging and SEO, and much more.

I’ve been helping clients succeed (and keeping them out of trouble with the FDA) for 20+ years!

Contact me today to ensure that your supplement marketing thrives while adhering to the legal framework.

Together, we can navigate the intricate regulatory landscape, write good copy, connect with your target audience and propel your business to success in this competitive industry.