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FDA Reader: Simplifying Food Regulation

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Food Labeling Errors That Can Cost You Your Business
 
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Food Labeling Errors That Can Cost You Your Business*

*and how to avoid them

Designing a food label can be a daunting task for an entrepreneur bringing a new product to market. Even after you check the boxes for nutrition facts, product claims, and display requirements, you still have to make it work with your packaging design. But if you don’t have time to make sure your label is 100% compliant with every last regulation, then at least avoid the following mistakes — they could cost you your business.

1. Undisclosed Allergens

Many FDA food recalls are related to undeclared allergens. This typically is the result of two easily-avoidable mistakes: (1) the ingredients listing on the package doesn’t match the product in the packaging and (2) The allergens in the product are not displayed prominently to the consumer.

How to Avoid This Mistake: Make sure your ingredients list is complete and that you are identifying any of the Big 8 allergens using an Allergen statement, such as “contains peanuts”.

Who Cares? The FDA, the person you made sick. 

Likelihood of Discovery: High. Food allergies are common and undeclared allergens tend to get discovered when a consumer has an allergic reaction to the product, despite having checked the label first.

What it will cost you: Because of the potentially life threatening nature of an allergic reaction to food, food manufacturers typically conduct an immediate, voluntary recall of all effected products.


2. Unauthorized Health Claims

There are clearly defined rules when it comes to the types of claims you can make about a food product’s effect on the consumer’s health. The easiest way to guarantee the wrath of the FDA and a swift food recall is to make an-unauthorized health claim or drug claim. This means making a claim about how the product or one of its ingredients affects your body or provides some sort of therapeutic affect. It is unlawful to make this type of claim on the product label itself but also on marketing materials (e.g. the company website), even if you have scientific evidence to back it up.

While the FDA has approved a small number of Authorized health claims approved for use, there are only twelve of them, plus a handful of weakly phrased qualified health claims.

How to Avoid This Mistake: Do not make any unauthorized claim about your product’s effect on the body or treatment of any ailment. Make sure any claims related to nutrition or the benefits of specific ingredients align with the regulation

Who Cares? The FDA. Here’s why: let’s say you claim that the high levels of antioxidants in your popular snack bar has been shown to support immune health in cancer patients. If cancer patients forsake treatment measures in favor of your snack bar, this could have negative public health outcomes. Major retailers will also pull these products from their shelves if they don’t discover this error before they place their order.

Likelihood of Discovery: High. Claims are typically printed prominently to get the consumer’s attention. This also means getting the attention of regulators and savvy consumers.

What it will cost you: All of the products and materials containing the unauthorized claim, possibility of brand damage and the possibility of expensive lawsuits from customers who suffered damages due to this claim..

3. No Standard of Identity (or a misleading one)

FDA labeling requirements clearly require most packaged foods to declare what the product is. This is why a Tostito’s label must clarify that the product is Tortilla Chips and Nutella must describe itself as Hazelnut Spread. While there is a great deal of controversy and open questions surrounding naming conventions for milk-alternatives and meat-alternatives, this isn’t the case for most products.

How to Avoid This Mistake: Include the common name for your product on the front label.

Who Cares? Major retailers who don’t want to be held accountable for carrying a product which could be construed as misleading.

Likelihood of Discovery: Medium-High. It may not be discovered initially, but eventually someone will notice. Typically, a failure to disclose a product’s Standard of Identity doesn’t have negative health implications for the consumer, it’s just mildly confusing, an infraction which rates lower on the FDA’s list of priorities. It’s more likely that a wholesale purchaser or retailer will find issue with this labeling error than the FDA.

What it will cost you: Mainstream retailers may refuse to carry the product until this issue is remedied.

4. Undeclared Ingredients

Even when there’s no allergen implications, the discovery of an undeclared ingredient in a product can bring public outrage to a boil and even lead to a food scare. Quite simply, consumers don’t like finding out that they have been lied to, particularly about what’s in their food.

How to Avoid This Mistake: Work with trusty suppliers and conduct supplier verification activities so you can have confidence in the ingredients you purchase. Make sure that your food labels and ingredients reflect changes made to the product formula.

Who Cares? Your most loyal customers; Twitter.

Likelihood of Discovery: Low-Medium. Using the final few rolls of old food labels after a slight change in product formulation will likely go unnoticed. The deliberate, ongoing failure to accurately convey ingredient composition is more common than we know. Large-scale food fraud can go undetected for years before being uncovered and technology is sometimes altogether incapable of detecting when ingredients are replaced with a cheaper alternative.

What it will cost you: The ongoing failure to accurately declare ingredient composition could result in lawsuits, fines, and total destruction of your brand.


 
How to Legally Sell CBD-Infused Foods
 
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Contrary to popular belief, Cannabidiol (CBD) does not exist in a legal gray zone. In fact, the regulations surrounding cannabis and CBD are clear, and for food producers looking to get into the market, there’s good news: There may be a legal route for selling CBD infused foods, supplements, and cosmetics, even if recreational cannabis use is not legal in your state.

Here are some guidelines about how to stay between the lines when it comes to selling CBD food products:

Verify Your CBD Ingredients

The 2018 Farm Bill legalized hemp as an agricultural commodity. This means it’s legal to possess, grow, sell, and transport hemp throughout the country, just like corn or sugar. Here’s the catch — it has to have a THC content of <0.3% and be hemp derived. Most importantly, it’s your responsibility as a food manufacturer to make sure your hemp- is compliant.

Tip #1: Only use CBD which is hemp-derived and with a THC content of below 0.3%. If you are sourcing CBD to include in a food product, it’s important that you work with reputable suppliers so that you can ensure your CBD ingredients are indeed legal. If your CBD ingredient exceeds the THC threshold then the ingredient will be classified as a Schedule 1 substance and your business could face serious legal repercussions. You may wish to request a certificate of analysis from your CBD supplier or consider sending out a sample of the product to a lab yourself.


Avoid FDA Oversight

At this point, the FDA has been very clear that CBD is not a legal ingredient in foods, cosmetics, and dietary supplements. However, FDA jurisdiction doesn’t cover all foods, so it’s possible to avoid FDA jurisdiction and legally sell CBD food products. Here’s how you can avoid falling under FDA Jurisdiction (Or check out our comprehensive guide to FDA Jurisdiction)

Tip #2 Sell CBD at your food service establishment. The FDA doesn’t regulate foodservice businesses — for example, food trucks, restaurants, and other places where food is served to customers for immediate consumption. These businesses are typically regulated by local health departments, most of which don’t explicitly disallow CBD as a food ingredient (see below). This is potentially good news for a cafe owner seeking to add CBD products to their menu. However, it doesn’t mean that a food manufacturer can avoid FDA jurisdiction merely by selling to food service establishments.

Another major factor which would trigger FDA jurisdiction is interstate commerce. This means that if you sell your product to a buyer which resides in a different state, then the FDA has jurisdiction over your food business.

Tip #3: Sell In-State. Limit the sales of your product to the state where you’re producing the product. This doesn’t mean “no ecommerce” but it does mean limiting your ecommerce to in-state buyers. Whether your customers are wholesale buyers or retail consumers, make sure they’re in-state.

Tip #4: Source In-State. If your product contains ingredients or packaging that was sourced from out of state, then your product has technically already entered interstate commerce, even before you assembled it. This gives a near-total breadth to the’s FDA jurisdictional claim since few items are 100% composed of ingredients sourced in-state. However, the FDA is unlikely to assert this broad of a jurisdictional claim. Bottom line: source your ingredients in state

Tip #5: Avoid making claims about the health benefits of CBD. So far, the FDA has only gone after CBD products which make claims about the health benefits of CBD. Avoid making any claims on your product label, marketing materials, or even your website — about the healing powers of CBD. Even if the claim is delicately worded “CBD may treat…”, it can still cause problems. Here are some examples of problematic health claims that the FDA has struck down:

“Cannabidiol may treat depression”

“CBD may be used to avoid or reduce withdrawal symptoms.”

“Due to its anti-inflammatory effect, cannabinoids may provide relief of joint pain and swelling."

“CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”


Understand and Follow The Local/State Laws

Even if you are able to strategically avoid FDA oversight, food production and sales will still be regulated by the local or state government.

Tip #6: Confirm your local or state jurisdiction has no specific regulation against CBD in food. Most jurisdictions have not specifically regulated against CBD as a food ingredient. However, if you are producing a CBD food product, it’s best to confirm this yourself before you receive an inspection from local health agencies. If CBD is an unlawful ingredient in your jurisdiction, then the health authorities may have the power to recall or quarantine your products. Here’s how you can figure out whether CBD is allowed for use in food.

  • Search online for the health code which governs food processing and see if CBD is among ingredients which are explicitly banned. Often the state regulates food processing and the city/local government regulates restaurants and each agency will have their own health code.

  • Confirm that your state/local health dept. doesn’t automatically operate under the FDA regulations. Some states, in order to avoid the hassle of writing and maintaining their own health regulations, merely adopt the FDA regulations as their own. You can find this out by searching online for the state/local health code. If your region adopts the FDA code, then this will be stated prominently at the beginning of the code (and it’ll be a short health code)

  • Call the health dept yourself and ask whether CBD is banned in food. This should be a last resort because, even if there’s no law to support it, the health dept will say that CBD is disallowed— this is because they want to avoid the hassle of dealing with this type of complexity Most CBD food businesses would rather quietly permit and operate their business and handle issues with the health dept if and when they appear organically.’’

Tip #7: Follow Industry-Standard Practices. If you producing and selling a CBD-infused product, you probably face more scrutiny than food products with less controversial ingredient compositions. Demonstrate your commitment to food safety and manufacturing standards by following the general health-code rules that apply to your product. If you’re creating a food product, this means operating in a suitable facility, following industry labeling standards, and following the local health dept regulation.

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