10 Legal Tips to Stop FDA from Classifying Your Dietary Supplement as a Drug

Shasta Canticle has a background in marketing and IT and wants to launch a sidelines business, manufacturing and distributing dietary supplements.

Shasta's cousin is an engineer with a particular love of medicinal herbal products, botanicals, and plants.

What they don't know is how FDA laws prohibiting disease claims for dietary supplements can kill their business idea.  Shasta calls our law firm and says point-blank: 'We're not going to make any claims, so we should be ok.'

Her cousin chimes in: 'Yeah, what's the worst that can happen?  We'll get a warning letter, we'll stop selling for a little while, change things up with our dietary supplements formulation, and be ok.'

10 Legal Keys to Avoiding FDA Enforcement for your Dietary Supplement Product

FDA regulates not just the dietary supplement label itself, but everything that the manufacturer or distributor says or writes about the dietary supplement.  The legal concept here is that FDA regulates not only the dietary supplement label, but also the dietary supplement labeling.  Anything 'appended' to the label, written or graphic, is considered labeling, and FDA can scrutinize all that marketing copy for claims.

For those like Shasta who says, 'we're not making any claims, so FDA can't touch us,' think again.  It's hard not to say anything, anywhere about a product.  Unless you're the Marcel Marceau of Marketing (think: pantomime), chances are, you'll say something and make a claim somewhere.

Make sure your dietary supplement lawyer informs you about these essential FDA legal rules about marketing dietary supplements:

1. FDA allows dietary supplement manufacturers and distributors to make structure/function claims

For dietary supplements, FDA allows manufacturers and distributors to make 'structure/function claims' but does not allow 'disease claims.'

A structure/function claim describes the role of a substance intended to maintain the structure of function of the body, or general well-being from consumption of a nutrient or dietary ingredient.

Typically, structure/function claims use language such as:

• Supports
• Stimulates
• Maintains
• Regulates
• Promotes (in association with a body system, organ or function)

Structure/function claims do not suggest disease prevention or treatment.

For example, 'supports heart health' is a structure/function claim for a dietary supplement.

2. FDA prohibits dietary supplements from making disease claims (drug claims).

A disease claim is a claim that a product will diagnose, cure, mitigate, treat, or prevent disease.

3. FDA regulations list 10 different ways a product can make a disease claim. 

That's right, there are 10 different ways you can make a disease claims for a product.

For example, FDA can find a disease claim if the product name suggests prevention or cure of a disease.

Other categories from the 10 include:

• A claim that the product has an effect on a disease
• A claim that the product is a substitute for a drug
• A claim that the product has a role in the body's response to a disease.

Also, a claim that consumers would understand to refer to a disease, is a disease claim.

For example, 'supports healthy lungs' is a structure/function claim, but 'maintains healthy lungs in smokers' is a disease claim.

Really, there are only two additional words here: 'in smokers.'  And that makes all the difference.

4. Even if your dietary supplement doesn't make a disease claim, FDA can take enforcement action if you fail to adequately substantiate your claim.

Substantiation is a second requirement for dietary supplement.  When you consult with your dietary supplement FDA lawyer, also ask about the substantiation requirement.  Basically, all statements about the product must be truthful and not misleading.

5. The substantiation requirement is very high.

All claims relating to health must be substantiated by 'competent and reliable scientific evidence.'

6. Even if your dietary supplement makes no disease claims, and makes structure/functions that can be substantiation, watch out for new dietary ingredients.

'New dietary ingredients' (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) will require a New Dietary Ingredient (NDI) submission to FDA.

7. Your contributions on social media also can make dietary supplement claims that get you in trouble; the social media sites also need legal review.
Claims on social media sites made are considered part of the dietary supplement 'labeling.'

Make sure your dietary supplement attorney reviews social media sites reviewed where the dietary supplement is promoted.

Social media sites can make disease claims and/or unsubstantiated claims about dietary supplements.  So can speeches, radio shows, TV spots, and statements to the media.

8. Consumer testimonials can make dietary supplement claims that are red flags for FDA enforcement.

FDA looks at consumer testimonials on the websites of dietary supplement manufacturers and distributors to see whether the company is approving disease claims.

For example, if the company markets the dietary supplement with a structure/function claim such as 'promotes healthy bones,' but a patient writes 'my osteoporosis is gone!' –and the dietary supplement company:

• Puts this testimonial on their website
• Puts this testimonial on a social media site, like a Facebook group
• Or LIKES the consumer's post

FDA could view this as the company making a disease claim in the product labeling.

9. FDA looks to evidence of 'intended use'

Bluntly put, anything the dietary supplement manufacturer or distributor does or says, anywhere, in print or on the airwaves or online, about the dietary supplement product, could be considered evidence of the dietary supplement company's 'intended use' for the product.

FDA looks to intended use when it classifies a product as either a dietary supplement or a drug.

That's why your dietary supplement lawyer should review all the claims you make for a given dietary supplement (or cosmetics) product.

10. FTC has overlapping enforcement jurisdiction.

The Federal Trade Commission (FTC) has overlapping jurisdiction over false and deceptive advertising, and can bring an enforcement action if any given claim is not supported by competent and reliable evidence.

One Way to Reduce FDA Enforcement Risk

An important risk mitigation technique our dietary supplement lawyers often recommend with clients like Shasta, is to reduce their 'footprint' or the size of the enforcement target, but reducing the number of claims.

Shasta and her cousin told us they weren't making any claims, and that they 'only' had a 'one-page,' website, but in fact, there were so many 'folds' below the fold, and Shasta wanted to say same thing so many different ways, that her company's dietary supplement webpage actually had over 50 claims.

The more claims, the bigger the enforcement target (and as well the bigger the target for third-party plaintiffs based on theories such as unfair competition or false advertising).

More Strategies for Reducing FDA Dietary Supplement Enforcement Risk

Here are more strategies our dietary supplement lawyers often recommend to clients such as Shasta who want to market their dietary supplement (or cosmetics) products:

• Limit the number of overall claims (yes, that means reducing marketing copy)
• Limit aggressive claims that FDA might view as disease claims, and restate if possible as structure/function claims
• Limit claims of scientific process, evidence, or mechanism that cannot be substantiated, or that imply a response to disease; and
• Ensure that claims are substantiated.

(Note: Reading this post promotes a good night's sleep.  This statement has not been evaluated by the FDA.  OK, that's our sense of humor.  We'll have to check our substantiation file.)

A World of Claims

As we've said, it is difficult to not make any claims.  As a dietary supplement manufacturer or distributor, you will not doubt want to say something about your product.  That's called marketing.

The dietary supplement attorneys in our healthcare and FDA law firm have worked on many kinds of dietary supplement products, including:

• Weight loss supplements
• Herbal products formulated from traditional oriental medicine
• Products aimed at promoting healthy hair
• Dietary supplements intended to enhance athletic performance, endurance and/or sexual potency
• Supplements meant to boost brain health
• And many other dietary supplement products

Clients seeking our FDA legal advice also have been manufacturers and distributors of cosmetics as well as OTC drugs, for products including:

• Hair care products
• Beauty products
• Slimming and body contouring products
• Weight loss products
• Products for health and vitality
• And many other cosmetics products

In the case of both dietary supplements and cosmetics, we work preventively with companies to help them avoid an FDA warning letter or other enforcement action in the first place.

We have also helped our clients in responding to FDA warning letters and other enforcement actions, including seizure and threat of fines and other penalties.

And we would say to Shasta's cousin that FDA is not required by law to issue a warning letter or stop with a warning letter.  No one in the cosmetics or dietary supplements business should have the attitude that the worst that can happen is a regulatory 'slap on the wrist.'  That would be naïve, and, dangerous.

Substantiation issues are often overlooked

Manufacturers and distributors of dietary supplements as well as cosmetics often overlook substantiation issues.

The reality is that offering health care products is different than offering health and wellness services (such as, for example, medical care or nursing support).  Products are regulated by FDA and FTC, whereas healthcare services are often regulated by state licensing boards.

And again, even if the product makes no disease claims, the claims also must be reviewed to be sure they can be substantiated.

Here are some common things you'll see about dietary supplements and cosmetics that can raise substantiation issues:

• Safe and effective

The issue here is, 'safe and effective' for what?

Safety and efficacy must be proven before a new drug can be put on the market.

Remember that dietary supplements can only make structure/function claims; cosmetics claims are even more limited than that.

• Scientifically supported ingredients

What makes the ingredients, 'scientifically supported?'  This begs the question as to whether the substantiation is actually there.  What does the literature show—where is the scientific evidence that the claim is true?

A certain amount of puffery is allowed by law; however, puffery can also lead to claims by aggressive, third-party plaintiff 'trolls.'  And that is another source of liability exposure, even apart from FDA and FTC.  We are reminded of the class action lawsuit against a restaurant chain that boasted about its mushroom burger, but as it turns out, delivered far fewer mushrooms than consumers would ordinarily expect from the chain's advertising.

The 'Not Evaluated by FDA Disclaimer'

A lot of the time, the legal discussions our dietary supplement and cosmetics lawyers lead, help clients separate the myths from the facts.

MYTH: The dietary supplement product is legally safe if you just slap the right disclaimer on it.

FACT: If you are a dietary supplement manufacturer, you must prepare a notification to FDA no later than 30 days after the first marketing of the product that you are making the structure/function statement in accordance with 21 CFR Section 101.93(a).  You will need to include the disclaimer: 'This statement has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure, or prevent any disease.'  However, the disclaimer will not prevent enforcement, if either:

• The dietary supplement product makes a disease claim, or
• The dietary supplement claim cannot be adequately substantiated.

Similarly, a disease claim for a cosmetic product will lead FDA to view the classification the product as a drug, and disclaimer will not cure this regulatory cataclysm.  Similarly, while qualifying language can potentially help mitigate false advertising issues, in general it isn't safe to assume that a disclaimer alone will prevent FDA or FTC enforcement.  The better practice is to have your FDA lawyer review the copy before putting it on the market.

Don't let yourself be in the position where FDA sends you an FDA warning letter or even harsher enforcement action such as telling you to stop selling your dietary supplement product.  Contact an FDA dietary supplement lawyer for FDA and FTC legal advice on how to bring your dietary supplement product to market.