What are the Label Compliance Requirements for Food, Beverage, Cosmetics, and Supplements?

Are you familiar with the label compliance requirements for your industry? Do you know if your food, beverage, cosmetic, or dietary supplement label is FDA compliant?

The Food & Drug Administration (FDA) has different label compliance guidelines for food, dietary supplements, and cosmetics. The requirements set by the FDA exist to protect consumers from confusing or misleading labels or websites. You can protect yourself from legal action by clearly stating your ingredients and suggested use and avoiding any claims related to diseases or medical conditions.

Putting all necessary information on your product labels is important for two main reasons:

Compliance affects your reputation. If you don’t follow FDA guidelines, you can undermine your brand’s credibility and trustworthiness. Consumers want to know that you are being honest and transparent with your ingredients and have their health and safety in mind.  

Noncompliance can lead to legal issues and costly product recalls. Many food and supplement brands have encountered lawsuits due to compliance issues or misleading info on their packaging or website.

Here is what you need to know about label compliance for your food, beverage, cosmetic, or dietary supplement.

If you are starting a supplement product, check out our Supplement Label Design guide.

Food & Beverage Label Compliance

The FDA separates food and beverages products from dietary supplements. Based on this separation, there are different labeling guidelines for each of the two types of products.

Label Compliance Requirements for food and beverages in the U.S., as outlined by the FDA:

1. Name of the product
2. Net quantity of contents displayed in both U.S. Customary System (lb, oz, fl oz) and Metric (g, kg, mL)
3. Ingredients – listed according to amount (highest to lowest), including any added colors, flavors, or preservatives
4. Declaration of presence of major allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, or soybeans.
5. Any ingredient sourced from a major allergen should be noted in the ingredient list. Example: lecithin (soy)
6. Nutrition Facts Panel including Serving Size, Calories, Total Fat, Percent of Daily Value (%DV), and Vitamins and Minerals (the FDA has a long list of rules and regulations regarding the Nutrition Facts Panel)
7. Name and address of the manufacturer, packer, or distributor
8. Nutrient Content Claims such as excellent source of…, high in…, reduced…, or “healthy” should be based on nutrient percentages defined by the FDA. 
9. Health claims on food packaging can be about disease risk reduction, they cannot claim to cure or treat a disease. Health claims must be submitted for approval to the FDA. Learn more about claims.

Specifically for Beverages:

1. Beverages that contain fruit or vegetable juice must declare the percentage of juice. Beverages that do not contain juice but refer to fruits or vegetables with images or text must state “Contains 0% Juice”
2. Ingredient list must be truthful. Terms such as “made from concentrate” or “reconstituted” should appear on the label if applicable.

Recommended:

1. Barcode
2. Storage recommendation such as “Perishable. Keep Refrigerated.”
3. “Best by” date
4. Country of origin

Country of Origin Labeling (COOL) is a labeling law pertaining to certain foods, referred to as “covered commodities.” Processed foods are excluded from COOL requirements. Packaged foods that have not undergone processing, such as a bag of frozen fruit, must list the country of origin on the label. Learn more about COOL.

It is also recommended that you include a barcode, storage recommendation, and a “Best by” date.

It is important to note that the FDA regulates individual products, not the companies that make them. Each product must follow current regulations. If companies truthfully provide all information on their product packaging, there shouldn’t be any issues.

Dietary Supplement Label Compliance

The FDA defines dietary supplements as “products intended to supplement the diet.” Even though dietary supplements are not submitted for approval to the FDA like drugs are, supplement manufacturers must comply with good manufacturing practices (GMPs) to ensure the purity and safety of the products they manufacture.

The FDA considers the following to be dietary supplements:

• Vitamins
• Minerals
• Herb or other botanicals
• Amino acids
• Dietary substances for use by man to supplement the diet by increasing the total dietary intake
• Concentrates, metabolites, constituents, extracts, or a combination of any ingredient mentioned above

Dietary supplements are differentiated from food and beverage products because they cannot replace actual foods. However, they do have a lot of the same labeling information as food and beverage products.

Label Compliance Requirements for dietary supplements, as outlined by the FDA:

1. Name of the dietary supplement
2. Net quantity of supplement
3. Name and address of the manufacturer or distributor
4. Front of label says “Dietary Supplement,” “Herbal Supplement,” or similar descriptor
5. Supplement Facts panel, including Serving Size, Percent of Daily Value (%DV) and Amount Per Serving (there are strict rules for how this panel is structured)
6. Ingredients – listed according to amount (highest to lowest), including any added flavors or preservatives
7. Declaration of presence of major allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, or soybeans
8. FDA disclaimer “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Disclaimer must use exact wording and appear in an outlined box. 
9. Comprehensive, easy-to-follow directions
10. Any required warning statements

Recommended:

1. Barcode
2. Storage instructions
3. Expiration date & lot number
4. Country of origin

A note on country of origin: 

The FDA does not require country of origin statements on food or dietary supplements. U.S. Customs and Border Protection (CBP) is the agency that regulates origin statements. CBP requires you to list the country of origin for any imported herbs or other ingredients. An exemption is made for imported ingredients that have undergone substantial transformation (such as being baked or changed in some way, not simply mixed together or repackaged). We recommend checking with your lawyer if you are unsure about listing the origin of your ingredients.

Dietary Supplement Claims

Making sure your product’s claims are in line with FDA guidelines can be tricky. There are specific rules around Nutrient, Health and Structure/Form Claims. Just a slight shift in meaning can put your claim in or out of line with recognized regulations. Here are a few examples for what you can and can’t claim for your supplement.

Three Examples of Permissible vs. Impermissible Structure/Form Claims

1. A product can’t claim to effect a certain disease or the symptoms of that disease

Impermissible: Helps reduce the effects of osteoporosis

Permissible: Helps maintain strong bones

2. A claim can’t refer to a sign or symptom that is characteristic of a disease or class of disease

Impermissible: Lowers blood pressure

Permissible: Helps to maintain heart health

3. Product names must not be a disguised claim

Impermissible: Arthritis Begone

Permissible: Joint Health

It is recommended that all structure/form claims be followed by an asterisk referring to the disclaimer “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

If you want to see a full guide for making product claims, you can check out our other article here.

Cosmetics Label Compliance

The FDA defines a cosmetic as a”product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance”.

Label Compliance Requirements for cosmetics, as outlined by the FDA:

1. Name of product
2. Identity statement (common or descriptive name that identifies the product)
3. Net quantity of contents displayed in both U.S. Customary System (lb, oz, fl oz) and Metric (g, kg, mL)
4. Name and address of the manufacturer or distributor
5. Ingredients – listed in descending order with appropriate International Nomenclature Cosmetic Ingredient (INCI) names
6. Directions for safe use
7. Any required warning or caution statements
8. Statement of origin ex: “Made in India”

Recommended:

1. Barcode
2. Certifications for cruelty free, organic, etc.
3. Commonly-used symbols such as Period After Opening (PAO). Learn more about certifications and symbols.

Similar to dietary supplements, cosmetics are prevented from making any claims related to diseases or medical conditions. For example, a cosmetic can claim to “promote clear skin” but may not claim to “treat acne” without going through the FDA drug approval process because acne is considered a medical condition.

In addition, beauty companies must carefully craft their messaging to avoid claims that their products affect the structure or function of the body. For example, a product can claim to make wrinkles less noticeable by saying something like “improves the appearance of fine lines” but can not claim to change the structure of skin. A product claiming to remove wrinkles or increase the skin’s collagen production would be considered both a drug and a cosmetic by the FDA. Cosmetics that are also drugs must be approved by the FDA before they can be sold to the public. 

To Keep in Mind

Adhering to government label compliance regulations is the best way to protect your brand. Accurate and truthful labeling will help you avoid legal issues and give your consumers confidence in the safety of your products. We always recommend having your labels proofed by a lawyer. This is something all the big companies do. Running everything by a lawyer before your product goes to market will help ensure you don’t run into issues.

Updating Your Artwork

If you’re ready to update up your labels or artwork to be compliant, our seasoned branding agency is here to lend a hand! Let’s chat today and get those updates sorted out together. Learn more with our Supplement Label Design guide.