Top 4 Functional Food Regulatory Trends In 2019

Posted by The Garner Group on Jun 2 2019


Once upon a time, breakfast was a simple affair.

A glass of orange juice, sunny-side up eggs, a few slivers of fried bacon, toast, and a muffin. 

Now, consumers are inundated with a wide array of choices. 

Let's start with the eggs. You have a choice of organic, omega-3 enriched, cage free, or pasture-raised. There's a slight difference between the last two. "Pasture-free" means that the chickens are allowed to roam freely outdoors. However, "cage-free" may only mean that the chickens aren't literally caged. They may be allowed access to a fenced-in yard or a covered barn.

As for the rest of breakfast, bacon and orange juice can be omega-3 fortified and calcium-fortified respectively. 

This trend in fortified, functional foods shows no signs of stopping. In March 2019, DNX Foods launched a grass-fed beef and uncured bacon jalapeno bar. This isn't your regular breakfast bar: it's fortified with omega-3 and CLA (conjugated linoleic acid). It also promises to be free of GMOs, MSG, artificial ingredients, antibiotics, hormones, nitrites, and nitrates.

DNA Foods has stopped short at making any nutrient content claims, however. 

That's certainly a smart choice.

Here's why: Bringing a functional food to market involves navigating a complex, ever-changing sea of regulations. Essentially, shifting rules and enforcement paradigms make this regulatory landscape a legal landmine. In this scenario, it's imperative that businesses understand what legal claims can be made about a fortified product. The goal is to identify both illegal and genuinely compelling claims. 

To do so, it's imperative that functional food executives stay abreast of the most notable functional food trends.

The Farm Bill and the FDA

The Agriculture Improvement Act of 2018 has been a hot topic of discussion, due to the legalization of hemp. Essentially, the bill changed hemp's legal classification. Now, hemp is off the list of federally controlled substances. which is expected to open legal channels for cannabidiol (CBD) to be included in functional foods and beverages.

Some companies have already explored the use of CBD in states where marijuana has been legalized. For the most part, the FDA aims to consider pathways for legal marketing of the supplement. With rising consumer interest in the compound, this is an excellent time to explore potential ways of incorporating CBD into wellness-orientated products. Expect further developments on the FDA's oversight strategy for CBD within the coming months, including the potential opportunity to provide feedback on emerging policies.

However, the question remains: is it currently legal to sell CBD-infused products? The unequivocal answer from the FDA is NO. To date, the FDA has actually issued several warning letters against businesses that have done so. 

Updated Standards of Identity

The FDA's Nutrition Innovation Strategy concerns itself with health and nutrition claims. Its goal is to keep consumers accurately informed about the food choices they make. In accordance with this long-term strategy goal, the agency is moving to update its standards of identity for many classes of food.

The updates will give companies more flexibility to make product improvements while marketing under the same classifications. This is good news for functional food companies that have been barred from using recognized names for popular products.

Modernization of FDA Claim Regulations

As another part of its Nutrition Innovation Strategy, the FDA is also updating the regulations surrounding marketing claims. One of the most relevant for those in the wellness industry is the redefinition of the word "healthy."

The agency hasn't changed the definition since 1994. However, an amendment appears imminent in light of recent nutritional science developments. A change will give companies the legal right to make certain nutrient content claims in their labeling.

Claudine Kavanaugh, a senior adviser at the FDA, has announced the intention to redefine similar terms relating to food groups as well. Changes in this area are sure to give nutritionally-complete products a leg up with health-conscious consumers. Stay tuned: the Garner Group is keeping a close eye on this one.

Fortified Beverage Regulation 

Coca-Cola recently requested that the FDA update its fortification policy regarding carbonated beverages. To date, carbonated beverages are considered foods with little to minimal nutritional value and so, may not be fortified. The FDA is concerned that fortification may encourage consumers to think of sodas and candies as "healthy" food choices.

Coca Cola maintains that it understands the FDA's rationale but argues that it should be allowed to fortify certain tea and juice beverages.

While no regulatory changes have yet resulted, we should not underestimate Coca-Cola's level of influence. Certainly, changes in this area will present huge implications for all functional beverage companies.

Staying Informed About Regulatory Requirements

Understanding regulatory trends at the state and federal levels is imperative to maintaining a sustainable functional food business. At its heart, regulatory compliance is necessary to prevent legal complications and to establish a socially responsible corporate image.

C-suite executives, in particular, experience significant challenges in helping their organizations navigate the functional foods legal minefield.

The Garner Group has extensive experience in not only monitoring these trends but also helping corporations navigate the changing tides. To learn how we can put our experience to work for you, contact us today.

Topics: regulatory affairs, functional foods, clean labeling, FDA, fortified foods

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