What Exactly Are Nutraceuticals?

According to the industry, nutraceuticals are ‘pharmaceutical grade’ nutrients that are consumed for a health benefit. In reality, they are vitamins, minerals, herbs, and extracts.

But you won’t find the word “nutraceutical” in federal law. The only place it appears on the FDA website is in the names of companies that have received warning letters for violating the FDA regulations.

According to the FDA regulations, most nutraceuticals would be categorized as “dietary supplements”. These are extracts, concentrates or combinations of vitamins, minerals, botanicals, herbs, or dietary substances  “for use by man to supplement the diet by increasing the total dietary intake.”

When is a Nutraceutical a Drug?

One of the primary indicators between dietary supplements and drugs relates to health claims. Whereas a dietary supplement is meant to provide nutrients, a drug is designed to treat illness or disease.

So, in order to maintain classification as a dietary supplement (and avoid the FDA’s strict drug approval process), Nutraceuticals must maintain that they are not intended to treat, diagnose, prevent, or cure diseases. So, no label claims about treating pain, or preventing cancer.

How Are Nutraceuticals Regulated?

Producers of nutraceuticals classified as dietary supplements are required to register their facility with the FDA. Much like foods, producers of nutraceuticals are expected to comply with Current Good Manufacturing Practices -- these outline facility standards, employee practices, and sanitation requirements, to ensure that the product is produced in a safe manner.

Labeling standards for dietary supplements are lumped together with those for foods. However, there are unique expectations for how dietary supplements are marketed and what claims they can make.

For the complete set of regulations on producing dietary supplements, check out the guided question set in 21 CFR 111

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It’s not always clear where  the FDA has jurisdiction when it comes to food businesses. This table provides an overview of FDA Jurisdiction. Specific examples are provided below.

Regulated By the FDA	Not Regulated By the FDA
Foods that enter interstate commerce	Food Service Establishments
Most packaged foods	Restaurants
Most foods solid online	Restaurant Chain
Human and animal food	Food Truck
Imported Foods	Caterer
Farms (if they grow and process food)	Grocery Stores
	Food Bank
	Cafeterias / Institutions
	Markets
	Home-Food Processor
	Alcoholic Beverages
	Butcher Shop
	Slaughterhouses (USDA)
	Farms (if they only grow food)

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*Note: Domestic food processors of any kind must still register as a Food Facility even if their products do not enter interstate commerce. This is free and purely for record keeping purposes (it will not subject a business to FDA inspections or oversight)

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Examples of FDA Jurisdiction Businesses

FDA Jurisdiction	Examples
Food products that enter interstate commerce (i.e. businesses whose foods leave the state)	Most foods sold online
	Most non-meat products that are made and sold in a package
	A central kitchen that prepares and distributes foods to locations in multiple states
	A transporter that distributes food nationwide
	Any business that processes, packs, transports, distributes, receives, or holds food which crosses state lines.
Imported Foods	Food distributor that imports foods and sells it
	Food importer that warehouses food

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Businesses Not Under FDA Jurisdiction

Not FDA Jurisdiction	Example	Who typically regulates
Restaurant (Individual)	Fast Food Restaurant	Local/State health dept.
Restaurant (Chain)	Chain of frozen yogurt restaurants	Each would be regulated individually by its respective local or state health department
Restaurant (Delivery only)	Meals are ordered via app/web and delivered hot to the consumer	Local/State health dept.*
Food Truck	Korean food truck	Local/State health dept. *
Caterer	Facility where a caterer prepares food for immediate service	Local/State health dept.*
Grocery Store	Grocery store that also serves some hot food or includes a deli	Local/State health dept.
Food Bank	Food bank that accepts food donations and distributes that food locally	Local/State health dept.
Cafeteria / Institution	Hospital cafeteria, School lunch cafeteria	Local/State health dept.
Farmers Market	Weekly market that offers various prepared foods and ingredients for sale	Local / State Health Dept
Seafood Market	Retail market that supplies seafood products to consumers	Local / State Health Dept
Alcoholic Beverage Producer, Importer, Distributor, Wholesaler	Winery, Brewery, Distillery	State Health Dept / TTB (Note that alcoholic beverages <7% ABC are subjected to FDA labeling standards)
Butcher Shop	Retail market that butchers and retails meat for consumers	Local/State Health Dept. OR USDA. (This depends on what level of processing is being done to the meat before it is sold)
Home Food Processor	Business conducted from the home that involves making food	Local / State – Note that many cities and states prohibit or specifically regulate home processing
Meat Product Processor	Frozen meat pies, Bone broth, High-quality cuts of steak delivered via mail	USDA
Poultry Product Processor	Frozen buffalo wings, Roast Chickens	USDA
Processed Egg Products	Frozen omelets, Egg whites	USDA

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*If you serve or prepare food in multiple areas you may have to license with the local health department for each of those jurisdictions. If the food is crossing state lines, then FDA regulation would apply.

Still Unsure Whether Your Business is Regulated by the FDA?

Ask a question in the comments and I’ll answer it

Try using this dichotomous key

What’s Next?

Understand about Registering a Food Facility with the FDA

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As incubator kitchens (commonly known as "shared-kitchens" or "commissary kitchens") pop up at an unprecedented rate, little attention has been paid to the regulation of these multiple tenant food processing facilities.

In this presentation to the Central Atlantic States Association of Food and Drug Officials, Ned Klein explains the regulatory landscape surrounding this business model and how food businesses and shared kitchen operators alike can protect themselves.

Bottom Line: FSMA has a severe impact on shared kitchens operate. For more about FSMA and food businesses, check out our detailed FSMA Guide

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Foods with a pH of <4.6 are called "Acid Foods" Some types of acid foods, such as acidified foods, are subject to specific regulation.

What are Acid Foods?

Acid Foods: A food with a natural pH of ≤4.6. There are many naturally acidic foods, including apples, yogurt, peaches, onions, tomatoes, strawberries and lemons.

"Acid Foods" as a general group are not regulated, although certain sub-groups of acid foods are.

Types of Acid Foods

There are two main types of acid foods

Acidified Food: These are low-acid foods that has been acidified by adding something acidic so that the end product is ultimately acidic has an equilibrium pH of ≤4.6) . This includes foods such as: dill pickles, hot sauce, and pickled fish.

The FDA does not include the following to be Acidified Foods:

• Carbonated Beverages

• Jams, jellies & preserves

• Naturally acid foods like peaches and most fruit juices

• Foods with a water activity of ≤0.85

• Foods which are stored under refrigeration

• Fermented foods (i.e. kimchi, sauerkraut, natto)

The FDA regulates acidified foods in 21 CFR Part 114.

Formulated Acid Foods: These are composed mostly of acid foods to which a small amount of low-acid ingredients are added (generally less than 10% by weight). The low proportion of low-acid ingredients means that the pH doesn't change significantly from the pH of the dominant ingredients. Examples include:

• Barbecue Sauce

• Salad Dressings

• Marinades

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Use this key to determine if your food is an acidified food.

FAQ

Is my product an Acidified Food?

Consider this flow chart to determine if your product is regulated by the FDA as an Acidified Food:

Click to enlarge

What's the difference between an acidified food and a formulated acid food?

The difference between these two types acid foods depends on the proportion of low acid and high-acid ingredients in each product:

Acidified foods are typically low acid foods with an added acid (which acidifies the low acid food.)

Formulated Acid foods are composed mainly of high acid foods with a small amount of low acid foods added.

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Formulated Acid Foods

In order to qualify as a "formulated acid food", the low-acid ingredients must not significantly shift the pH of the product from the natural pH of the high-acid ingredients.

For a food product whose equilibrium (final) pH is <4.0, then a shift of up to 0.4 is considered insignificant.

For a food product whose equilibrium (final) pH is >4.0, then a shift of up to 0.1 is considered insignificant.:

Example #1:  Ned's BBQ Sauce.

Ingredients by weight: Tomato paste (93%), Sugar (5%), Spices (2%)

Ned's BBQ Sauce Equilibrium pH: 3.9

pH of only High-Acid Ingredients: 3.6

Change between high-acid ingredients and final product = 0.3

Since the equilibrium pH of Ned's BBQ Sauce is below 4.0, only an increase of 0.4 or more would be considered significant. Since the low-acid ingredients only increase the pH by 0.3, this change is considered insignificant.

Outcome: Ned's BBQ Sauce is a Formulated Acid Food. It is not subject to 21CFR Part 114

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Example #2: Ned's Marinade

Ingredients by weight: Tomatoes (60%) Onion (10%) Vinegar (20%) Sugar (7%) Spices (3%)

Ned's Marinade Equilibrium pH: 4.2

pH of only High-Acid Ingredients: 4.0

Change between high-acid ingredients and final product = 0.2

Since the equilibrium pH of Ned's BBQ Sauce is above 4.0, an increase of above 0.1 would be considered significant. Since the low-acid ingredients increase the pH by 0.2, this change is considered significant.

Outcome: Ned's BBQ Sauce is an acidified food. As a result, it is subject to The regulations in 21 CFR Part 114.

More on Specially-Regulated Foods

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What is E. Coli?

The Escherichia Coli bacteria shown under a microscope

We all know that E. coli is a threat to human health that is transmitted by food. But what foods specifically? How is it controlled and how can we protect ourselves from it as eaters and food producers?

The Basics:

Escherichia coli is a bacteria that produces a toxin called “Shiga”, that can cause food borne illness and even death.

Associated Foods:

• Raw ground beef

• Raw seed sprouts

• Raw milk

• Unpasteurized juice

• Foods contaminated by fecal matter

Transmission: 

Human-to-Human or via contaminated food.

Incubation Period: 

Usually 3-4 days after exposure, but it can range from 1-9 days.

Symptoms:

• None (it can be asymptomatic)

• Diarrhea

• Bloody Diarrhea

• Kidney failure

Control Measures (i.e. how we stop it)

• Cooking food to 155º for 15 seconds will kill E. coli.

• No bare hand contact with ready-to-eat (RTE) foods

• Strong employee health policies (i.e. no sick employees handling food)

• Hand washing

• Prevention of cross-contamination

• Pasteurization or treatment of juice

The Bottom Line:

E Coli is a dangerous bacteria that can be transmitted via food and cause tremendous harm. At the same time, it’s something we can control quite easily and, if you are taking appropriate precautions, should not be something to worry about.

If you have more questions about how to control E. coli, ask in the comments section below.

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Resources

FDA “Big Bad Book on Bugs” E. Coli Section

More about Food Safety

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