.svg)
.png)
Want to make treats for pets full-time? Whether you’re manufacturing treats, gravies, or meals for pets at home or at a commercial facility, there are certain guidelines you should follow to avoid misbranding and product recalls.
Currently, pet products are regulated at two levels- by the Food and Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO.) And while there are no requirements for premarket approvals, the Federal Food, Drug, and Cosmetic Act (FFDCA) mandates that pet foods, like human foods, should be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.
This could mean taking care of a lot of requirements from publishing the ingredient list in a certain way to making sure the Guaranteed Analysis requirement on your label is accurate.
That’s why we’ve created this comprehensive guide with all the FDA and AAFCO regulations, along with a FREE downloadable checklist.
This article contains:
- The Key Differences Between Pet Food And Pet Drugs
- Legal Definitions of Terms
- Required Label Statements
- Conclusion
Let’s start by understanding the key differences between pet food and drugs.
The Key Differences Between Pet Food And Pet Drugs
The FFDCA defines the term food as “articles used for food or drink for man or other animals...and articles used for components of any such article.”
This is often interpreted by courts to mean products that are primarily used for taste, nutrition, aroma, or components of that product. For example, cat food that contains the amino acid taurine that may help with heart health in cats.
While the FFDCA defines drug to include, among other things, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or function of the body of man or other animals.”
For example, a product intended to make a cat’s urine more acidic to maintain urinary tract health.
It’s important to note that FDA’s premarket review to be legally marketed is not required for pet food products but it’s mandatory for pet drugs.
Legal Definitions Of Terms
Here are a few legal definitions you should know prior to reading this guide to avoid confusion and misunderstandings.
Principal Display Panel (PDP)
The Principal Display Panel (PDP) is the label’s front panel and the part a consumer will see first under customary display conditions for retail sale. It must be large enough to accommodate the required label statements.
Note: Although products have labels on their inner and outer containers, they have only one PDP on the outer package.
Information Panel (IP)
The Information Panel (IP) refers to the back and side panels of a label. If a package has more than one PDP, the IP is the panel to the immediate right of any PDP.
Required Label Statements
Here are 9 label statements that should be included on your labels for pet food products:
1. Product Name
Product names can focus on one particular aspect of the product, say “beef” or “tuna”. Because many consumers purchase a product seeing that one ingredient, there are four AAFCO rules you must follow to list the product component in the name.
I. The 95% Rule
This rule is applicable for products that consist primarily of very few ingredients. For example, a product could have the name “Beef for Dogs”.
In such a case, the said product component, beef, should amount to at least 95% of the total weight of the product, excluding water and other condiments added for processing.
If water and other condiments were included, the named ingredient must still comprise 70% of the product.
Note: In case the name includes a combination of ingredients, such as, “Chicken and Fish Dog Food”, the two named ingredients must comprise 95% of the total weight.
II. The 25% Or “Dinner” Rule
This rule is applicable to canned and dry products. If the named ingredients contain at least 25% of the product (excluding the water for processing) but is less than 95%, the product name must include a qualifying descriptive term such as “dinner”. For example, “Chicken Dinner for dogs.”
Including the added water, the said ingredient must still comprise 10% of the product. Descriptors other than dinner may also be used such as “platter”, “entree”, “formula”, and “nuggets”.
Note: If multiple product components are being used in the name, such as, “Chicken and Fish Dinner Cat Food”, these both ingredients must total 25% of the product, and each named ingredient must be at least 3% of the total.
III. The 3% Or “With” Rule
The use of the term “with” such as “Cat food With Fish” mandates that fish should be at least 3% of the product.
IV. “Flavor” Rule
No specific percentage is required in this case but a product must contain an amount sufficient that it can be detected.
It’s also mandated that in the name “Beef Flavor Dog Food,” the word “flavor” must appear on the label in the same font, size, and color as the word “beef”.
2. Net Quantity Statement
This indicates how much product the container has. Since a bag that may typically hold 40 pounds of food may only be having 30 pounds of food and the rest may be puffed up, it’s wise to make a cost-per-ounce or per-pound comparison.
The AAFCO mandates expressing the weight in an ounce-pound unit and must include the appropriate metric unit, such as 50 lb (22.67 kg)
Abbreviations can be used for the units in the Net Quantity statement. Although this could both be in the lowercase or uppercase, lowercase is mostly preferred. For example, oz for ounce, qt for quart, gal for gallon, lb for pound, and fl for fluid. Metric units should be in lowercase only. Exceptions are mL for milliliter and L for litre.
Note: If this statement is in terms of units of count such as capsules or tablets, this information must be coupled with a statement of weight or size of individual units to convey the amount of feed present.
3. Manufacturer’s Name and Address
The manufacturer’s name along with the street address, city, state, and zip code must be printed on the label. The street address may be omitted if they’re listed in the current city directory or phone book.
If the food is not manufactured by the responsible party, the name should be qualified with a phrase, “Manufactured for __________” or “Distributed by _________”.
The manufacturer can state the principal place of business in the address in lieu of the actual place where the actual feed was manufactured, packed, or distributed as long as it is not misleading.
4. Ingredient List
According to Federal law, ingredients in the ingredient statement must be listed in descending order of predominance by weight in the product.
All the ingredient names must be printed in the same size and typeface. The names used must be according to the official common name as defined by AAFCO and listed in chapter 6 of the AAFCO OP. If the official name does not exist, it should be listed by their common or usual name such as sugar, salt, etc.
If a common ingredient like apple is processed into its constituents, eg. starch, fiber, etc., these constituents are not to be treated as the original ingredient and a new ingredient definition must be established.
Ingredients used as vitamins, trace minerals, or carriers for drugs, don’t have to be listed unless they comprise at least 1% of the feed by weight. In case organic ingredients are used, you may list them as organic, such as “organic corn”, “organic wheat”, and so on if they’re certified organic.
Note: No reference to quality or grade of ingredients can be made in this statement.
5. Guaranteed Analysis
Many state regulations and AAFCO require pet food companies to guarantee the minimum and maximum percentages of certain components such as protein, fat, and so on.
The basic guarantees include a minimum percentage of crude protein and crude fat and a maximum percentage of crude fat and moisture unless these values are zero. It’s important here to note that “crude” means the specific method used to test the product, not the quality of the nutrient itself.
Guarantees for other nutrients may be required to support claims made on the label. For example: high in calcium. Voluntary guarantees may also be included on the label. Manufacturers must ensure that these values are declared taking into account a statistical consideration of sampling errors, method errors, product variations, preparation errors, etc.
These guarantees will be printed in a specific order as mentioned in the AAFCO guidelines.
Here’s a detailed order for the same.
How To Express Guarantees
- Guarantees for crude protein, equivalent crude protein from NPN, lysine, methionine, other amino acids, crude fat, crude fiber, ADF, and NDF must be stated as a percentage by weight.
- Guarantees for calcium, salt, and sodium when present, must be stated in percentage by weight in the following format:
a) When the minimum percentage is below 2.5%, the maximum shall not exceed the minimum by more than one-half of a percentage point (for example, minimum 2.0%, maximum 2.5%).
b) When the minimum percentage is between 2.5% and 5.0%, the maximum shall not exceed the minimum by more than 1 percentage point (minimum 3.0%, maximum 4.0%.)
c) When the minimum is above 5%, the maximum shall not exceed the minimum by more than 20% of the minimum and by not more than 5 percentage points (minimum 28.0%, maximum 33.0%).
3. When stated, guarantees for minimum and maximum salt and total sodium, minimum potassium, magnesium, sulfur, phosphorus, and maximum fluorine, shall be expressed as a percentage by weight.
4. Other mineral guarantees, when present, must be stated in parts per million (ppm) when the concentration is less than 10,000 ppm (1%) or must be stated as a percentage by weight if the concentration is greater than 10,000 ppm (1.0%).
Mineral guarantees must be grouped in order of unit of measurement.
5. Guarantees for vitamins, when present, shall be stated in the following units:
- Vitamin A, D, and E, International Units (IU) per pound
- Vitamin D3 for Poultry Feeds, International Chick Units (ICU) per pound
- Vitamin B12 in milligrams or micrograms per pound
- All other vitamins, milligrams per pound
Note:
- When species-specific feed guarantees require a copper, selenium, or zinc guarantee, it must be expressed as parts per million (ppm).
- Guarantees for crude protein, crude fat, and crude fiber are not required when the feed is not intended to supply those substances or they are present in levels too low to make a significant contribution to the intended function of the feed.
For species-specific guarantees, refer to the Tables in AAFCO OP.
6. Nutritional Adequacy Statement
FDA deems a pet product unsafe if it claims to be “complete”, “balanced”, “100% nutritious” which suggests a product is suitable for sole nourishment when in reality it’s not.
If you want to label it as a “complete and balanced” pet food, you have to substantiate this nutritional adequacy by either of these two steps:
- The first method involves the pet food having all the ingredients formulated to provide levels of nutrients that meet an established profile. Presently, the AAFCO Dog or Cat Food Nutrient Profiles are used.
Products that meet these profiles should henceforth include the words “(Name of product) is formulated to meet the nutritional levels established by the AAFCO (Dog/Cat) Food Nutrient Profiles”
- The second method involves testing the product using AAFCO Feeding Trial Protocol. In this, the product is fed to dogs or cats under strict guidelines and found to provide proper nutrition.
These products should carry the words “Animal feeding tests using AAFCO procedures substantiate that (name of product) provides complete and balanced nutrition."
This statement should also mention for which life stage the product is suitable such as for “growth” or “maintenance”.
A few products also meet the stringent nutritional needs “for all life stages”
For the products that do not meet either of these methods or life stages, they should state “This product is intended for intermittent or supplemental feeding only” unless the product is identified as “snack”, “supplement” or “treat”.
7. Feeding Directions
Feeding directions educate the customer on how much product should be offered to the animal. At a minimum, this includes statements such as:
If these instructions can’t be printed on the front of the label, you must direct the reader to its location on the feed label such as “see back of the label for feeding directions”
This statement also mentions that caution and warning statements must appear in a prominent place on the label.
In the case of medicated feed, the user should be provided with specific information regarding the intended dosage, weight restriction, mixing instructions, and withdrawal time, if any.
8. Calorie Statement
According to AAFCO regulations, manufacturers should include a calorie statement on all pet food products.
This must be expressed on a “kilocalories per kilogram” basis. Over this, manufacturers are also required to express calories in familiar household units such as “per cup” or “per can”
Note: Just like guaranteed analysis, the calorie statement is made on an “as fed” basis so corrections for moisture content must be made while counting the total calories.
9. Other Label Claims
Many pet food products are labeled as “natural”, “premium” and even “super-premium.” Products labeled “premium” aren’t required to contain any higher quality or different ingredients.
They’re not even held up to any higher nutritional standards than other complete and balanced products.
But to use the term “natural” on pet food products, AAFCO has developed a definition for what types of ingredients can be considered “natural”.
For the most part, this definition can be construed as equivalent to a lack of artificial flavors, colors, or artificial preservatives in the product. That said, natural preservatives such as mixed tocopherols can be used.
Note: “Natural” isn’t the same as “organic” as the latter refers to conditions in which plants and animals were raised. To make an organic labelling claim, the pet food must satisfy the criteria set by the United States Department of Agriculture (USDA.)
Conclusion
While pet food products may not require approval from FDA before launching in the market, you might want to take care of all these guidelines and adhere to them to avoid any future conflict.
You can try our label management software to reduce errors while creating labels for your products. We have also created a checklist for you to ensure you have taken care of all of them so that proofing errors do not happen at the last stage.
Download this FREE checklist today and stay on top of FDA and AAFCO regulations.
