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Policing Claims

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K2VITAL®

Claims that can be used on food and dietary supplement labels fall into three categories: health claims, nutrient content claims and structure/function claims. The responsibility for ensuring the validity of these claims rests with the manufacturer, Food and Drug Administration (FDA) or, in the case of advertising, with the Federal Trade Commission (FTC.)

Section 403(r)(6) of the of the Federal Food, Drug and Cosmetic Act, in general, requires dietary supplement manufacturers to have substantiation that structure/ function, nutrient deficiency and general well-being claims on a dietary supplement product’s labeling are truthful and not misleading.

To meet this statutory requirement, the FDA recommends that manufacturers possess adequate substantiation for each reasonable interpretation of the claims. The FDA said it applies a standard that is consistent with the FTC standard of “competent and reliable scientific evidence” to substantiate a claim.

Changes to this act have been limited, however, in recent years, applications of these regulations are expanding.

Michael McGuffin, president of the American Herbal Products Association (AHPA, Silver Spring, MD), pointed out that FDA does not focus on marketing or advertising claims unless the claims lead to concerns about adulteration or the making of drug claims. “Which, by default, makes this conversation one about FTC,” he noted. “Overall, we have not seen any new enforcement initiatives from FTC in some time as [its] laws are fairly well established, unlike those at FDA.” In fact, he said, the last time there was substantial activity around dietary supplement products at FTC was in 2004 in the weight loss area.

“While there is now a mood against new regulations among many legislators on Capitol Hill, we have seen an increase in enforcement activities and budgets in recent years,” said John Gay, executive director and CEO, Natural Products Association (NPA, Washington, DC).

“A few years ago, FTC tightened up its direction to industry regarding the use of testimonials, but there has been no other actions that we’re aware of,” added McGuffin.

That’s true for Bob Green, president of Nutratech, Inc. (West Caldwell, NJ), who noted that the 2009 FTC Guidelines Concerning the Use of Endorsements and Testimonials In Advertising is very specific about what manufacturers can and cannot say. “What’s new is that these rules for traditional advertising and other marketing communications are now being applied to the internet and social media.

“Manufacturers or retailers that deal with MLMs (multi-level marketing), franchisees or distributorships have to be aware that there’s a whole new level of regulation in play,” Green added. “MLMs, franchisees and distributorships often result in many more people promoting products—speaking on behalf of your company—on their own websites and Facebook pages, as well as on Twitter, LinkedIn and other social media. And as a manufacturer, you are responsible for what they say.”

Though regulations of supplement claims remain relatively unchanged, how the FDA and FTC enforce these rules and how the industry responds is evolving

Clearing Out Bad Players 

Because of money and manpower constraints, FDA and FTC are being selective about the rule breakers they pursue, and they appear to fall into two categories, said Green. “One group is comprised of ‘egregious offenders.’ Unfortunately, this often includes our category—weight management—where there almost always appears to be a few renegade companies that promise miraculous weight loss without diet and exercise. It’s this sort of hyperbole that gives the entire weight management category a black eye, and brings it to the attention of the FDA and FTC. That’s why Nutratech has always taken a responsible stance to weight management with Advantra Z, our patented bitter orange extract.” 

The other group includes companies that deal with health conditions—particularly cholesterol, pain and inflammation, Green continued. “These conditions impact actual diseases, which is definitely outside of the purview of DSHEA,” he said. “But also, these claims directly encroach on what has traditionally been pharmaceutical territory. And these companies not only have deep pocketbooks, they also have large, active lobby groups, which exert great influence over regulatory agencies. So manufacturers of these kinds of products are particularly vulnerable— they need to follow the DSHEA law to the letter and make sure their marketing messages are supported by research.” 

Selectivity may not be the correct word to describe the FDA’s and FTC’s decisions on disciplinary pursuit. “The agencies would likely say otherwise, but both FDA and FTC have what Congress (and by extension, the people of the United States) want them to have,” McGuffin argued.

He added that in January 2010, FTC sent a warning letter to Northwest Naturals for a line of kids’ “gummy” vitamins that included omega-3 fatty acids. FTC warned the company over health claims. In December 2010, FTC announced a $2.1 million settlement with NBTY, Nature’s Smart and Rexall Sundown regarding brain and eye health claims. “There is really nothing new of note in 2011 as FTC has been administratively bogged down and is using significant resources with other issues, including the POM Wonderful lawsuit,” McGuffin said.

Categories known to attract the most attention from regulators and that continue to come under fire are weight loss, sports and sexual enhancement products, added Gay. “These are categories in which consumers may be looking for instant or dramatic results. Consumers and retailers alike should be cautious of any product that sounds too good to be true.” 

Nutratech is well aware of problems in this area since the company is focused exclusively on weight management, sports nutrition and energy. “There has been a lot of hyperbole and false promises in these categories. Regulatory agencies have stepped in in the past and will continue to so,” said Green. “The regulatory problems that this category has encountered have only strengthened our commitment to providing scientifically supported raw materials.” 

Green recalled a history of regulatory enforcement issues for the weight-loss category. “Back in 1997, the FTC launched a sting operation called ‘Operation Waistline.’ In 2004, it was ‘Operation Big Fat Lie.’ Both were nationwide law enforcement sweeps against companies making false weightloss claims in national advertisements,” he said. “The FTC’s goal was to stop deceptive advertising, provide refunds to consumers harmed by unscrupulous advertisers and encourage media outlets not to carry these advertisements. And this effort continues.” 

In addition, Gay said the NPA has seen more attention on a few products in the functional foods category, in particular products that are conventional foods that claim to be supplements. “NPA believes that regulators need to act against any products masquerading as supplements.” 

And since the functional food/beverage/ ingredient market is in its infancy, Green added that there’s no doubt that the biggest challenge for this category is the regulatory environment. “That is because functional foods and beverages are essentially dietary supplementfood hybrids. Both food and dietary supplements are regulated by the FDA, but the regulations that govern each are very different,” he noted. “The Federal Food, Drug, and Cosmetic Act governs the safety of food, drugs and cosmetics. Meanwhile, DSHEA provides the framework for assuring the safety of dietary supplements and dietary ingredients, setting guidelines for labeling, use of claims and nutritional support statements, and establishing other criteria unique to dietary supplements and dietary ingredients.

“But no one has yet determined under what set of regulations functional foods/beverages will be governed,” Green said. “The FDA/FTC have started to draw some lines in sand, like sending warning letters to high-profile manufacturers and marketers who are selling bars and ready-to-drink mixes as dietary supplements and, conversely, those who are marketing powdered dietary supplements as beverages or drinks. So there will probably be even more red flags raised until the current nebulous regulatory environment is ironed out.” 

Claims and NDIs 

While new dietary ingredient (NDI) standards should not affect claims regulation, Green said he sees regulatory agencies using the FDA’s NDI guidance draft as a method for potentially eliminating or restricting the sale of certain dietary supplements—particularly natural herbs and botanicals.

“As drafted, the guidelines appear to lean toward product regulation rather than ingredient regulation, placing the burden on manufacturers to submit NDI notifications on every finished product,” he said. “Under these conditions, it seems to me that manufacturers will have to push this responsibility down to ingredient suppliers and require them to supply evidence of marketing prior to October 1994, or provide the necessary safety and toxicity data in their Standardized Information on Dietary Ingredients (SIDI) forms. Since Nutratech is a supplier nutraceutical ingredients for weight loss, fitness and energy, we are in the process of preparing our operations to handle this onslaught of technical support from customers should the NDI guidance document go through as is.” 

If this guidance document passes unchanged, the burden on the industry, as well as on the FDA, will be extensive, Green noted. “Just think of all the time and effort that will be required to make even a minor formula change. I can’t imagine that the already resourcechallenged FDA will be able to manage the submissions in an effective and timely manner. This has the potential of bringing new product development— the lifeblood of any industry—to a screeching halt.” 

Media Watch 

As more products are made available for purchase online, certainly more attention will be paid to them there. Regulatory oversight continues for print and broadcast media as well, said Gay.

“As far as we know,” added McGuffin, “FTC reviews all forms of media. The agency seems to be looking closely at TV ads, and we know that FTC is willing to look at advertising claims on websites.” 

“They’re looking at all aspects of marketing communications and that includes traditional advertising, as well as websites and social media,” agreed Green. “And we as an industry have to face facts: the internet makes it much easier for the FDA and FTC to monitor marketing claims. It’s not like the old days when they would have to shop retail stores and go to trades shows. There’s much easier access now, and manufacturers who don’t follow the letter of the law are much less likely to skate by.” 

For Manufacturers 

So when making claims, manufacturers must be cognizant of the rules. “We see some making fundamental mistakes like claiming their product can treat, cure or mitigate a disease,” said Gay. “NPA can help, and there is information available from the FTC and FDA as well.” 

When a manufacturer is in violation, unlike what’s been seen with FDA’s actions, FTC will try to get the money spent on the products back to consumers, McGuffin added. “That’s what it aims for in its settlements, and it can be very damaging to the company found to be in violation.”

To enhance awareness of the claims regulatory environment for manufacturers and suppliers, McGuffin said AHPA tries to keep its membership informed and it responds to federal agencies whenever they try to change the regulations. “But that hasn’t happened since 2008 (the use of testimonials). FTC did propose in late 2010 that its telemarketing rules be changed. AHPA did not comment.” 

Last year, NPA along with other trade associations endorsed the FDA’s actions to hold accountable those who violate the law by illegally marketing products they claim are dietary supplements but, in reality, contain undeclared or deceptively labeled ingredients that do not qualify as dietary supplements. “We continue to update our members about government regulations that apply to their businesses, as well as their responsibilities under the law,” said Gay.

“Most of our trade organizations have had programs in place to help members to stay in line with the tenets of DSHEA—like NPA’s TruLabel program,” Green added. “But the few unscrupulous manufacturers that give our industry a bad name aren’t usually members of industry associations. So while these trade programs can be helpful to keep their membership in line with the FDA/FTC regulations and guidelines, they alone are not going to solve the problem.” 

One area that offers an example of where there have been advancements in the industry as well as a place that needs improvement is full implementation of the cGMPs, said Gay. “As manufacturers fully align with the cGMPs, consumer confidence will grow even stronger. At the same time, cGMP inspections by FDA have uncovered both inconsistencies on FDA’s part, as well as some basic violations on the part of some manufacturers. So there is room for improvement on both sides.”

Albion Minerals®
 
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