USDA-FSIS Product Claims: What Do The Regulations Mean?

The USDA-FSIS (Food Safety And Inspection Service) product claims are a specific piece of legislation for labelling of packages and cover a wide range of claims.

The USA Food Packaging Regulations

You must consider two departments, the Food & Drug Administration (FDA) and the USDA’s FSIS!

1. FDA

• All those foods except the ones listed in the next section under USDA rules.
• No labelling or packaging approvals are ever given
• The FDA uses surveillance from FDA and/or consumers to find and catch errors
• It has the power to issue warning letters or make a recall.

       2. The USDA-FSIS 

• The USDA-FSIS covers all meat, some eggs, Siluriformes which refers to catfish, and poultry.
• Under USA law requires the USDA to pre-approve ALL labeling. Before 1996 all packaging labelling went to the FSIS for approval but this has relaxed now. 
• Due to the high volume of individual approvals, the USDA created a ‘Generics’ approvals process in 1996.
• The generic labels MUST be in compliance with all regulations and therefor approved without the USDA viewing them. The USDA still monitors packaging but through the regulations.

The USDA-FSIS Label Approval Process

The Labeling and Program delivery Staff (LPDS) reviews sketches of label and gives their stamp of approval if it passes their regulations and requirements.

There are four categories of labels that require LPDS approval. These are:-

• Labels for temporary approval
• labels for religious exempt products
• Label with export deviations from domestic requirements. The exported products labeling must be reviewed and approved by the FSIS,
• labels with special statements and claims

The final label can then be ‘generically’ approved with minor changes from the sketch approval. The FSIS can issue temporary approval if needs be. If there are  major changes to the label then t must be resubmitted. There are occasions when approved labels are rescinded if the approval was made incorrectly or the found to be in error.  Special claims and statements require USDA approval too. 

The USDA-FSIS Label Approval Process

Generic labels which comply with ALL regulations can be approved without the LPDS viewing them by virtue of regulatory compliance to all acts, directives, laws and so on.

if there is an error in the label then it is not considered to be approved and a local inspector can stop production or request a recall.

A temporary approval can be granted if the proposed labeling would not cause misinterpretation of the product; the use of such labeling would not present any potential health, safety or dietary issues and problems to the consumer, of if denial of the request would create undue economic hardship. Also, temporary approvals are granted if an unfair competitive advantage does not result from the granting of temporary approval.

Product packaging must  comply with the following FSIS Regulation Sources. They are the following:

• Congressional Acts that establish the government laws
• Code of Federal Regulations (CFR) such as Title 9: Meat & Poultry & Title 7: Eggs, Organic and CN (child nutrition).
• Policy Memos
• Food Standards & Labeling Policy Book
• Directives & Notices
• Guidance Documents – get into specifics such as claims and special claims especially.

All Generic Labels must be in compliance with all sources of USDA regulations. USDA inspectors look at all products regularly and of  everyday use and these inspectors have to be in a slaughter house when slaughter is being undertaken.  The FDA monitors the situation every three to five years.

Healthy As A Claim

Any claim must be FSIS approved or it is not valid on a label

Using icons such as hearts, liver, kidney etc., would convey a health claim message and these also fall under FSIS legislation.

Healthy Claims For Individual Foods

To make any healthy claims for an individual food it must meet the following requirements:

1. It meets a Low Fat regulation of ≤ 3g per RACC (reference amount customarily consumed)
2. It meets a Low saturated fat regulation of ≤ 1g saturated fats per RACC
3. No more than 15 per cent of calories from saturated fat.
4. cannot contain more than 60mg of cholesterol per RACC and labeled serving size (per 50g if the RACC is less than 30 grams).
5. Cannot contain more than 480mg of sodium per RACC
6. Contains 10 per cent or more of the RDI or DRV per reference for any one of the following nutrients; vitamin A, vitamin C, calcium, iron, fibre (fiber) or protein.

Healthy Claims Under The USDA: Entreé, Main Dish Or Meal

To make any healthy claims for a main dish or a meal it must meet the following requirements:

1. It meets a low fat regulation of ≤ 3g per 100 grams of product
2. It meets a low saturated fat regulation of ≤ 3g per 100 grams of product
3. Not more than 30 per cent of calories can come from total fat.
4. Not more than 10 per cent of calories from saturated fat.
5. Products weighing less than 12 ounces per serving must not contain more than 60mg of cholesterol
6. Products weighing more than 12 ounces per serving as on the container may contain no more than 90 mg of cholesterol
7. No serving can contain more than 600mg of sodium
8. Products weight 6 to 10 ounces per serving must have the RDI or DRV level being met by just two of the listed nutrients which are vitamin A, vitamin C, calcium, iron, protein or fibre (fiber).
9. products weighting 10 ounces or more must have three of the nutrients to meet RDI or DRV values. 

Healthy Claims Under The USDA: Single Ingredient Raw Meat And Poultry

To meet the Extra Lean regulation, the serving must contain less than 5g of total fat and less than 2g of saturated fat

There must also be less than 95mg of cholesterol per reference amount and per 100g.

Such food does not have a sodium requirement.

What’s The Difference Between ‘Health’ And ‘Healthy’?

Health has no specific regulation so the FSIS will have to review either based on FDA regulated ‘health’ claims or in conjunction with third party certification.

A statement on the label needs to describe any relationship between a food and a particular disease or condition. Good examples are offered by the American Heart Association (AHA). Some examples include meat products such as extra lean poultry, with an image of a heart (stylised or not) and a ‘heart healthy’ claim. A claim for health usually has to be applied such as ‘While many factors affect heart disease…..’

No Gluten

To make a common enough claim like ‘no gluten’ requires FSIS approval. The regulatory allowance of this wheat protein is no more than 20 ppm. It can have company verification with a certified and a testing option to show gluten is virtually absent. The paperwork must be available for inspection and support that claim.

A Gluten Free organization can be referred to which must have a web-site and make claims as to their policy but in compliance with the law.

Genetically Modified Claims (No GMOs)

Again, FSIS approval is needed. It should refer to either or both ingredients and to meat although the latter designation is more complicated to make a claim for because not all feed is GMO free. The no GMO claim must state the material it is referring to. It is thought that more specific wording is required such as (1) derived from beef fed no GMO feed or (2) contains No GMO ingredients.

Where 3rd party certification or an organic claim is used then it must be stated on the label.

The bioengineered statements now have different regulations. 

Omega 3 Content Claims

Here, FSIS approval is also needed and like the GMO claims issue must refer to the ingredients used or the meat which is being sold.  The omega fatty acid content cannot come from fortification. 

The phrase ‘Good source of Omega-3 fatty Acids’ is not permitted and neither are symbols allowed. Interestingly it is not allowed in Nutrition Facts labelling either.

Very specific wording is used such as:-

(1) X grams of Omega-3 per serving from a specific ingredient such as canola oil or some other specified source

(2) X mg of omega-3 Fatty acids per serving

For meat, you need documents to support special feed formulas.

Organic Claims

1. All organic claims require FSIS approval.
2. They must be audited by the USDA-AMS certifying body (usually a branch).
3. Must state on the label who the certifying body is
4. Must meet requirements for birth, feed and management
5. Other raising claims are substantiated such as: Vegetarian diet, No added hormones, No animal by-products, non-GMO and humanely raised.
6. The whole product can be organic or just its ingredients. A meat could be non-organic but the added ingredients were from organic sources.
7. A statement like ‘made with organic ingredients’ must have at least 70% of these and no shield.
8. A specific ingredient cannot earn a shield or be ‘organic by itself’.

Breed Claims

1. Must have FSIS approval
2. Used to promote particular types and varieties of animals
3. Good example in the meat sector are Hereford (beef), Berkshire, Yorkshire, Silkie, Muscovy (duck), Wagyu (beef) and American Kobe, Angus (beef), Duroc,
4. Documentation must be signed and dated by an authority to support any breeding/breed claim. The authority could be a certified USDA -AMS program for that breed, a certificate from a breed association or indeed other forms of verification but using a recognised authority.
5. Traceability and segregation of the breed must also be documented.
6. The approval can be based on phenotype as well as genotype.

Animal Raising Claims

1. Must have FSIS approval.
2. Must have detailed written descriptions of controls to make sure of validity. This must also be signed and dated.
3. Need written details on product tracing and segregation.
4. Need third party certification which requires the name of the certifies, a web-site address and logo if applicable on the label. An organic product does not need a website.
5. The regulation details are well described and found in the FSIS Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims for Label Submissions (update Dec. 2019).

Examples include:

No Added Hormones

• The hormones must be approved for use in pigs (swine), lamb and cattle.
• If a claim is made for other species, a qualifier is needed that states Federal law prohibits hormone use in that species.

No Added Antibiotics

• Animals cannot be given antibiotics in any of their feed, water or by injection at any point in their lifespan.
• No ionophores because the USDA considers they are anti-bacterial antibiotics are permitted
• No administration such as by injection is allowed in poultry for pre-hatch or in ovo (i.e. in the egg).
• You can allow a claim of ‘No sub-therapeutic antibiotics’ with an additional qualifier stating they are given antibiotics when they are sick. The USDA are trying to remove the prevention of diseases using antibiotics. 

Cage Free

Being cage free is not that well defined in law so the claim must describe what Cage Free actually means. A description of what the claim means needs to be on that label.

An asterisk or other symbol may connect claim to a  description on what that claim means in terms of how the animal was raised.

If it is 3rd party certified, who has established and accredited standards on their web-site than it must have on the label a certifying name, a website and logo if applicable.

Humanely Raised

You must have additional wording on the label describing the meaning of the claim around how and why they were cared for while being raised. There is no legal definition of this type of raising.

The entity that established the standard must be mentioned.

If it is 3rd party certified, they must have established standards on their website, the label contains the certifying name, a website name and logo if applicable.

So we have discussed USDA-FSIS Product Claims – I hope it is a useful reference document. If you need any help, we are available to discuss such labeling regulations if you are exporting products to the USA for example.