Many of our dietary supplement companies come to us with various mistaken assumptions with respect to labeling their dietary supplement products.
Let’s talk about 5 key dietary supplement labeling mistakes and how to avoid them.
Mistake # 1 – Underestimating Dietary Supplement Labeling
Most of the dietary supplement manufacturers and white-label contract labelers that come to us for FDA legal and regulatory advice, don’t realize that dietary supplement labeling actually involves at least three different tasks:
- The technical aspects of the dietary supplement label on the bottle and box.
- “Labeling,” which refers to the website and all other marketing materials (including social media sites) associated with the product. This also includes consumer testimonials about dietary supplements on the Company’s website.
- Substantiation, which refers to the proof behind a particular claim.
When we advise dietary supplement companies on labeling, we want to make sure all three areas are covered. Sometimes the companies themselves will handle one of these internally, with their teams. For example, companies can gather the scientific information and evidence behind a particular claim, to ensure that the marketing department isn’t pushing too hard for claims that are beyond the plausible and supportable.
Alternatively, companies can choose claims that are well-established in industry and in the literature. For example, “Echinacea support the immune system” is a dietary supplement claim that probably won’t bring down the wrath of FDA or FTC.
Mistake # 2 – Underestimating FDA Enforcement
Dietary supplement companies often underestimate the sweep of potential FDA enforcement.
We even had a client recently say, “no big deal, I’ll get a warning letter, it’s a slap on the wrist.”
There are some fatal flaws in that line of non-reasoning. First of all, a warning from the Government—that’s public, to boot—not exactly great marketing … and there are no second chances.
Second, agencies often coordinate enforcement. FDA talks to FTC and Attorneys General can get involved. There is nothing light about enforcement.
Third, to begin to understand the full scope of FDA enforcement, take a look at FDA, Inspections, Compliance, Enforcement, and Criminal Investigations. Among the links you’ll find Criminal Investigations. Just in the post as of today’s writing, Owner of O.C. Pet Products Company Pleads Guilty to Selling Pet Meds without Prescriptions. Some of Which Were Not Approved for U.S. Sale.
Remember that dietary supplements that make disease claims can be considered unapproved new drugs.
According to the above criminal action:
LOS ANGELES – A Laguna Hills man pleaded guilty today to charges of selling misbranded veterinary medications without a prescription, some of which were not approved for use in the United States.
Sean Gerson, 49, the owner Vaccination Services, Inc. in Lake Forest, pleaded guilty in a scheme that netted him at least $2.5 million over the past 15 years.
Gerson pleaded guilty to smuggling, introduction into interstate commerce misbranded animal prescription drugs with the intent to defraud and mislead the United States Food and Drug Administration, and a misdemeanor charge of distribution and sale of an unregistered pesticide. Vaccination Services also pleaded guilty today to the same federal charges.
The misbranded drugs – meaning they were sold without a valid prescription from a veterinarian – were Comfortis, an anti-flea medication, and Ciprofloxacin, a powerful antibiotic commonly called “Cipro” that can be used in dogs and cats to treat skin, respiratory and urinary tract infections.
Notice the penalty:
In addition to the prison sentence and criminal fine, Gerson has agreed to the entry of a $2.5 million forfeiture judgment which will require Gerson to forfeit the proceeds of his long-running scheme.
See also our prior posts:
FDA takes aggressive stance on dietary supplement promotion and labeling
The FDA has taken an aggressive stance on dietary supplement promotion and labeling in recent warning letters involving dietary supplement manufacturers’ and distributors’ response to […]
FDA issues warning letter to dietary supplement company for including cancer or diabetes in search field
The FDA issued a warning letter citing a dietary supplement company for its online content.
FDA and FTC Encourage Public to Report Dietary Supplement Labeling Violations
If you’re a dietary supplement manufacturer or distributor, know that FDA and FTC now encourage the public to report dietary supplement labeling violations.
Mistake # 3 – Relying on Someone Else’s Label
Many companies make the mistake of relying on someone else’s dietary supplement label. That “someone else” could be a competitor whose label the dietary supplement company finds on the Internet. Or it could be the contract manufacturer that is actually manufacturing the dietary supplement. Either way, relying on someone else’s dietary supplement label is a bad idea.
Just because that dietary supplement label is out on the market, doesn’t mean it’s compliant.
You have to understand the concept of pre-market approval. Premarket approval means that FDA must approve the product before it gets to market. Importantly, Rx drugs require premarket approval by FDA. This can take a decade and hundreds of millions of dollars – and various stages of drug development clinical trials. In contrast, dietary supplements do not require premarket approval. This means that, as much as FDA (and other regulatory authorities) police claims, in many ways it’s a Wild West out there.
The fact that one town has a sheriff or a marshal and another doesn’t; or that one company got picked off at “high noon” at the “OK Corral” of FDA enforcement and another didn’t, doesn’t mean that your particular dietary supplement labeling practices are compliant.
Put another way, what’s out in the market is no indication of what’s legal.
Don’t mistake “someone else is doing it” for “I’m compliant.”
As they say, “tell it to the judge” (or FDA investigator). And good luck. Don’t make this mistake.
Mistake # 4 – Making too Many Claims
This is a relatively easy area to fix, yet so many dietary supplement companies get it wrong. The principle is simple: the more claims, the bigger the target. Conversely: the fewer the claims, the smaller the target.
Many dietary supplement companies call us and say: “We only have a few claims.” They really believe that. However, if you look at their websites, they have many web pages devoted to claims about the products; and even a single product page can contain a dozen or more claims.
For example, it’s one thing to review “Echinacea supports the immune system,” but about a product that:
- Improves mood
- Increases neurological functioning
- Promotes synaptic firing
- Helps those with early symptoms of Alzheimer’s
- Promotes mental clarity, especially for the elderly
- Boosts memory
- Prevents neurodegeneration
- Provides neuroprotection
And so on …. Let’s say that the dietary supplement products are also marketed by a physician (MD) who has white-labeled the supplements. This MD has a series of videos in which he talks about “the science behind the supplements.” These videos in turn make additional claims.
Because everything you say about your dietary supplement product, every statement of benefit, could be a claim.
Now in a legal review, some of these claims will obviously fall within the allowable, structure/function arena; some will obviously fall within the FDA-prohibited, disease claim arena; and many will be gray or dubious. In the latter case, we can look to FDA warning letters as one primary resource to see whether FDA has flagged specific claims. We can also look to regulations and FDA guidance documents.
There will be a bigger enforcement target, and much more lawyering to do, the more extensive the claims.
Why do dietary supplement companies make so many claims? Some marketing “experts” think that more is better. Many simply go on and on, naively assuming that the more they say, the more they pile on the benefits which will make the herbal product, vitamin, or mineral more persuasive to the consumer. Others are so convinced by their own view of the “science” that they want to trumpet a whole bunch of theories.
Cure this mistake by titrating the aggressiveness of the marketing against sensible compliance guidelines, and by limiting the sheer number of claims and hence the size of the enforcement target.
Mistake # 5 – Underestimating FTC Enforcement
While FDA’s current practice is normally to issue an FDA warning letter to a dietary supplement manufacturer or distributor who has made unlawful claims, violated GMP practices, or otherwise broken FDA law, FTC can shut down the company and force the company to disgorge illegal profits.
In other words, when FDA knocks, your dietary supplement manufacturer or distributor can often hire FDA legal counsel to respond to the FDA warning, and propose a compliance plan in response to the FDA warning letter.
When FTC knocks with a Civil Investigative Demand (CID), it is often the beginning of the end. FTC does not take kindly to claims that FTC considers false, deceptive or misleading. Companies that FTC believes have profited from such claims often have to pony up the unlawfully gotten revenues in a heavy FTC penalty.
Often, FTC will announce a penalty many times what FTC actually charges the company. Nonetheless, the actual penalty could be in the millions of dollars.
Remember that FTC requires that claims for health products be substantiated, or backed by proof, according to the standard of “competent and reliable scientific evidence.”
See our prior posts:
FTC Statement to Congress on Deceptive Marketing of Dietary Supplements
The FTC Statement to Congress on Deceptive Marketing of Dietary Supplements is a good place to begin to understand legal compliance issues regarding marketing.
Dietary Supplements, Cosmetics, Medical Devices – Why Substantiating Claims Matters
Substantiating claims matters whenever you bring a dietary supplement, cosmetic (or skin care product), or medical device to market – why?
As we’ve previously noted, dietary supplement companies face many sources of legal risk:
- FDA investigation and enforcement – i.e., possibly a warning letter but also the potential for steeper enforcement such as seizing products and halting sales
- FTC enforcement action – i.e., large penalties and big headlines
- NAD report (National Advertising Division of the Better Business Bureau) – a review of national advertising for truthfulness and accuracy (self-regulation with a public report, copy to FTC)
- Private plaintiff action – a plaintiffs’ law firm may bring a class action and allege deceptive and misleading advertising
- Competitors’ action for unfair competition and false advertising
- State Attorney General action for misleading business practices
When it comes to labeling your dietary supplement products, don’t make the mistakes that land many dietary supplement companies into trouble.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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