Watch Your Labeling
Just like good gossip, bad labeling and claims can start early–and create trouble.
Your labeling can make or break you. In addition to investing time and money to create a visually appealing dress that encourages a consumer to physically inspect it on a shelf, it needs to also properly convey its contents, its directions of use, and its promise of specific efficacy (ie, “supports healthy cognition.”) If you “over promise,” it likely means it is misbranded—or, illegal.
The landmark Dietary Supplement Health and Education Act of 1994 (DSHEA) created a clear and concise platform for the consumption of dietary supplements in daily life across the board. The architects looked to the word “supplement” as the cue to explain that they are to be consumed to supplement a diet for the purpose of supporting the structure and function of a particular area (organ or system) in the human body. In so doing, DSHEA allows for the distinction that supplements are not intended to treat, cure or mitigate a disease state—this is the sole province of pharmaceuticals, which frequently cause intense and dramatic side effects—the very reason why they are monitored by prescribing physicians.
And yet, many dietary supplement brand marketers overlook their labels and accompanying marketing materials. Even subtle “mistakes” can get you into hot water. Just like good gossip, bad claims may often start at the supplier level.
Supplier’s Role
When a brand marketer identifies a niche to fill with a new supplement product, the need then arises to investigate competitive ingredients, both key and supportive, to begin formulation. Companies new to the industry but no less devoted to providing products that help consumers live healthier lives, may have a tough time navigating the landscape of supply, contract manufacturing and proper distribution, along with allied services such as marketing. Beyond scoping out suppliers for ensuring quality, purity, safety and efficacy of ingredients, they need to also select suppliers that likewise market their ingredients legally.
According to Patrick Luchsinger, nutrition marketing manager with Illinois-based Ingredion Incorporated, the first two questions brand marketers/ manufacturers must ask when researching and working with suppliers in order to be confident that they follow Food and Drug Administration (FDA) and Federal Trade Commission (FTC) rules is “What message will our target audience take from this messaging and is this messaging aligned with what the peer-reviewed published data allows?” Ingredion’s WEIGHTAIN weight-management ingredient, he noted, has a recently published study supporting its effects to support earlier onset satiety as demonstrated through fewer calories consumed compared to control.
In the dietary supplement industry, the ingredient suppliers are typically responsible for a lot of research that gets done, through solid investment in clinical trials, therefore, the claims start at the ingredient level. Suppliers, too, market heavily via their internet and social media presence, along with printed materials. And many do cross the line, according to Steve Mister, CEO, Council for Responsible Nutrition (CRN). There are some suppliers that don’t think that consumers (much less federal authorities) can find their websites marketed to industry and believe that the immune support ingredient, for example, will “treat a cold” because the proprietary clinical trial showed lessening of duration or symptoms.
“There needs to be strict caution to the supplier,” Mister stated. “I have heard some suppliers say, ‘I’m only marketing B-to-B, not to the consumer, so I’m not worried about making prohibited disease claims.’ I caution very strongly against that way of thinking. The FDA not only looks to see if a supplement is misbranded but also looks at the nature of the ingredient and can state that it is a drug because of the definition in the Food Drug and Cosmetic Act—the intended use of the ingredient.”
If an ingredient supplier has put out marketing material about how its ingredient treats or cures a disease state, it is easier for the FDA to present a strong case of how that ingredient is intended to be used, even if the end consumer really never saw the supplier’s website. FDA can find it, and use it as evidence.
Mister also explained that there is a dilemma for suppliers generating research that supports use of their ingredient. Often, suppliers want to investigate their ingredient’s viability in a population with a disease state, as it is easier and more meaningful to show effect. For example, a supplier of an ingredient that supports healthy blood pressure will want to do clinical studies on people with high blood pressure to clarify positive effects— however, this cannot be discussed or presented, as it would be a disease claim. However, studies that show a lowering effect on healthy people who may have slightly elevated blood pressure still within normal parameters, can allow the brand marketer to say supports healthy blood pressure already within normal ranges; this is acceptable to the FDA—which may ask to see those studies on healthy participants for validation. “It’s not that the supplier can’t invest in studies of folks with higher and unhealthy blood pressure (disease population), but to make a legal claim, you must have a study that matches,” he explained. “It’s the same with weight loss—you may do studies on an obese population, but obesity is considered a disease, therefore, doing studies on people who are slightly overweight and want to drop 10 pounds is acceptable as that is not a disease state.
As another example, Mister added that the word “inflammatory” is also quite a red flag that will draw FDA attention. It must be used in the context that is not a disease state (such as osteoarthritis). You may say that the product is “for minor inflammation resulting from exercise,” which again, is not a disease.
Checking the Details
David Biderman, Esq., partner with Perkins Coie, headquartered in Seattle, WA, advised that brand marketers need to be extremely cautious and careful during the quest for sourcing ingredients and to ensure that the supplier is reputable. “It’s also very important for any manufacturer to have strict internal guidelines that govern the supply, and these guidelines should be based on federal or state regulatory standards. You should keep detailed records of the ingredients that have been supplied and the due diligence that has been done by the supplier, and keep records that would allow you to track where the ingredients ended up,” he asserted.
Biderman elaborated that if do your due diligence on the supplier and have internal guidelines in place, if at some point and time you get sued, you can use that compliance as a basis for defense. Finally, you should make sure to include an indemnity agreement in your contracts with suppliers.
In agreement is Bob Green, chairman, Novel Ingredient Services, based in New Jersey, a veteran ingredient manufacturer. He provided a host of questions to use as a guiding blueprint to determine if that supplier may make the final cut.
• How long has this company serviced the natural products industry?
• How experienced are they on the regulatory front?
• What is their expertise?
• How will you know if the ingredients have been properly vetted to conform to DSHEA?
• What guarantees can they provide to ensure the validity of their documentation? (Just because ingredient suppliers provide information doesn’t mean they are trained and knowledgeable about our industry. In fact, they’re often not.)
• Do they truly understand the DSHEA laws and monitor the FTC rulings that impact label claims on an ongoing basis?
Luchsinger added it “is best to start the review of the science and its health benefits early in the new product development process and proceed with the claims and the review. The earlier a manufacturer/brand can thoroughly investigate the science of the ingredient and review the claims they would like to phrase the benefits of that ingredient to the consumer the better.”
In his experience the most effective process in creating legally sound label claims is to:
1. Thoroughly review the science supporting the ingredient’s health benefits.
2. Innovate compelling phrasing of claims for the product.
3. Review those different claims with expert regulatory counsel.
4. Beta test those claims on consumer focus groups and choose the best scientifically and regulatory vetted claims that resonate well with the consumer.
“We who have lived through the ingredient/supplement wars for decades understand what to believe and what to discard as BS,” said Mitch Skop, senior director of new product development with New Jersey-based Pharmachem Laboratories Inc. “Companies that market consumer products must have competent regulatory counsel—and some good common sense—before applying a label to a bottle and printing, posting or distributing promotional and educational literature. A guideline is to stick to the adage that if it sounds too good to be true to the consumer, it is; go back to the drawing board.”
Skop added that Pharmachem does not make claims; “however, in the case of one of our ingredients (Phase 2) , the FDA and NHPD have offered claims language that is unique to this ingredient. The language is conservative yet meaningful, and that’s what Pharmachem worked for. It allows for truthful and non-misleading language for consumers.”
Repercussions
When seeking to launch a new supplement or a new supplement line, if you don’t do due diligence to ensure claims and promotional collateral, you may be setting up your company for quite the arduous legal journey.
Mister explained that when the FDA catches a bad claim, it is apt to submit a warning letter requiring this to be addressed very quickly. If a claim is really egregious, it may conduct a recall due to misbranding. One concern shared by the FDA and FTC is that if the supplement is marketed for a disease, it may prevent the person from getting the real medical assistance he or she needs.
When the FTC catches misleading marketing materials, it is less concerned about structure and function but more concerned about consumers being misled. It will serve you with papers asserting that your company is under investigation. FTC, Mister warned, also can file a complaint in court against your company, or you can settle it with a consent decree—admitting wrongdoing and disgorging unjust profits in either civil penalties or restitution to the consumer.” This can be a multi-million dollar mistake,” he stated.
He revealed, “One of the things CRN is battling is when you sign a consent decree, the FTC then holds you to much higher standards than others in the industry; they call it fencing in. Therefore, going forward, you are then required to submit two randomized clinical trials for any claim, the same required by pharmaceutical companies for each drug.”
Biderman said, “There are three overarching types of repercussions: Private consumer class actions. With supplements in particular, there is the possibility for personal injury claims for failure to warn, and those are broad. Governmental claims. These can also be broad and involve some sort of government enforcement action, such as with the FTC, to pull a product or change a label. Government investigations. This allows the government wide power to ask for particular documents and call the company CEO before Congress, for example. ”
The repercussions, noted Green, can be enormously expensive. Expenses include but are not limited to having to recreate and reprint all of your labels or, if you print right on the bottle or canister, you may have to throw away your packaging and start over. The worst-case scenario, is that may have to recall the product from store shelves.
“These days,” Skop observed, “even properly labeled products are subject to the mass class action suits that we hear about almost daily, so imagine what an improperly labeled product is subject to? The National Advertising Division of the Better Business Bureau (BBB), the FTC, the FDA plus class-action-happy lawyers equals a tough path to follow on the best day, so be careful, truthful and conservative,” he advised.
A tough competitive space may inspire some brand marketers to push the envelope, but Skop warns that this may be playing with fire. Instead, he says, make sure you have “truth in advertising times 10.”
Green pointed out that marketing materials are considered extensions of the label. “There are some manufacturers that will take risks in their advertising and brochures that they wouldn’t with their labels. But again, pulling or changing advertising is costly—especially if it’s television advertising.”
Beyond working with knowledgeable and ethical suppliers, as well as legal experts, working with professional writers and consumer media experts who understand the difference between legal and illegal language and presentation is also highly recommended.
When it comes to advertising and marketing your product, it is not just the words that are scrutinized by the FTC, said Mister; this agency reviews the totality including photo/art elements. If the art element conveys a sick/ill state of being that is giving the message that the product will treat or cure.
If you are a brand marketer you need to have good legal counsel advising you before you put anything on a label or marketing material. You cannot rely on what the ingredient supplier says. Companies need to work with suppliers that understand the law. If the supplier doesn’t know or care to know the difference between disease claims and nutrient claim, I advise to not work with it.
To add to the stress is the FDA’s proposed new food label guidelines, which many in the industry are concerned will morph over to dietary supplements. According to Mister, these proposed food label guidelines “will affect supplements because some of the things they are doing is changing some of the Daily Values (DVs) of some nutrients. If you have those nutrients in your supplement formula, you may either have to change your labeling or your formula, because as it will stand, it will not be the same percentage. For example, if the product now has 100 percent DV of a nutrient, it may become 80 percent or 110 percent; if you want to have 100 percent DV of it, you may have to reformulate. If you let it stand, you need a new label,” he explained,” adding that CRN is closely following the rulemaking.
Green is a bit more conservative, noting that it remains to be seen. He reminds that dietary supplements were considered foods prior to the enactment of DSHEA in 1994; supplements are still considered a subset of food, and FDA guidelines for food labeling (Nutrition Fact boxes) have sometimes historically been applied to dietary supplements (Supplement Fact boxes). “But for these proposed foods label guidelines to affect dietary supplements, there will have to be proposals for similar changes specifying dietary supplement, Supplement Fact boxes,” he commented.
In the meantime, remaining on the good side of the FDA/FTC regarding labels and promotional materials is a sound idea that can save your company and employees a lot of heartache.
