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Staying compliant with FDA regulations is essential but difficult as it involves a lot of legalese, and the regulations change over time without any notice. We’ve created an overview of labeling regulations to simplify the process and added how Artwork Flow would make adherence to compliance a breeze.
The Code of Federal Regulations (CFR) lists general rules all food products, cosmetics, and medical devices must adhere to if they want to be sold within the United States.
Failure to comply with these regulations leads to misbranding and product recalls, damaging your reputation and brand image.
So, let’s take a look at the required label statements for cosmetics, drugs, and foods.
The 21 CFR Part 11 was introduced to provide guidance to businesses that maintain electronic records and submit information electronically. Here’s how Artwork Flow helps businesses adhere to these regulations. It automates the workflow to help you get e-signatures from internal and external stakeholders securely. Helps you create audit trails to ensure trustworthiness and reliability of records with automated versioning and history tracking.
Restrict access and secure sensitive information during the artwork review and approval process by allowing access to only selective members. Overall, our tools help you reduce the number of artwork revisions, increase your speed to market, and help you stay compliant. Still not convinced? Check out how we helped a popular Indian snacks enterprise maintain compliance and prevent recalls here. And sign-up for a 7-Day FREE trial of Artwork Flow if you’d like to stay compliant without any hassle and get a taste of improved artwork efficiency.
The PDP refers to the part of the label a consumer is most likely to see when they pick up a product.
Since the identity and Net quantity statements must be displayed on the PDP, it must be large enough to be visible to consumers. So, the PDP area is calculated as shown below to determine the font size.
The IP is the panel to the immediate right of the PDP and contains important information like the Manufacturer’s address, Ingredients list, Net Quantity, Nutritional label panels, and Claims.
All the information displayed on this panel must be at least 1/16 in. and have a contrasting background to ensure that all the important information is visible on the panel.
Note: The label text should contrast with the background color and must be devoid of obscuring vignettes and graphics so that the text on the PDP and IP is visible to consumers. Now, let’s look at the CFR regulations for the required label statements.
Required Label Statements - The required label statements refer to the information you must print on the PDP and IP so consumers can get the information needed to make an informed purchasing decision. Here’s a list of these statements grouped according to the type of product you’re selling:
These statements must appear on your labels regardless of the products you’re selling.
The Identity Statement tells the consumer the product’s name and its nature. In the case of food items, these statements must also include additional information on the form (diced, whole, diced, etc.,) in which the food item is manufactured. Dietary Supplements follow a similar rule, but you can replace the word “Dietary” in the Identity statement with the description of a dietary ingredient.
For example, If your supplement is made of herbs, your Identity Statement can be “Herbal Supplement” instead of Dietary Supplement.
Here’s the FDA’s Dietary supplement labeling guide to help you understand these requirements better.
If the product is a cosmetic or drug, the Identity Statement will include the product’s name and the product name. For example, If you’re selling a body lotion under the brand name Skin Glo, Body lotion is the nature of the product, and Skin Glo is your product name.
The Net Quantity Statement appears on the PDP and is the amount of product your container has by weight, measure, or numeric count. You must make a net quantity declaration in the US and metric designations and use the right units for liquid and weight measures. You must declare statements of weight in avoirdupois pounds and ounces while liquid measures must be in sub-divisions of the gallon, quart, pint, etc., Also, these statements must have a Net wt. or Net Contents before or after the declaration is made, but liquids are exempted from this rule.
Here are a few examples of a correct Net Quantity Statement: Net wt. 6 oz, 6 oz Net wt., 6 fl oz
To calculate the minimum font size for the net quantity declaration, refer to the table below.
You must mention the address of the manufacturing facility at which your product is made on the Information Panel of your label. For example, if your company manufactures your product under a separate division, then mention the division’s address.
And if your company doesn’t manufacture your product, mention the manufacturer’s and distributor’s address followed by qualifying phrases like “Manufactured For ____” and “Distributed By _____.”
In the case of drugs, if different persons are involved in the different drug manufacturing processes, you must state their designation and the process they were involved in. For example, “Filled by (Person A),” Sterilized By (Person B), etc.,
You should always declare all ingredients in descending order of predominance, i.e. the ingredients present in the highest concentration should be listed first before listing color additives.
If your product is a cosmetic and a drug, the active ingredients that make up the drug should be listed in descending order of predominance before the remaining ingredients are listed the same way.
If you’re distributing a food product, there are a few other additional required label statements you shouldn’t miss on your labels to avoid the misbranded product label.
This label lists all the nutrient information for a discrete unit or a single serving size, i.e., the amount of product typically consumed per eating occasion by consumers above 4 years of age.
However, if you’re selling a dietary supplement, you’ll have to add a “Supplementary Facts” Panel instead of a Nutritional label panel and list the nutrients accordingly.
Statements, vignettes, or graphics that implicitly or explicitly characterize the level of nutrients present or imply that the product can help with a health-related condition are called claims.
You can’t make a claim unless your product adheres to conditions laid down by the CFR. Check out these CFR nutrient claims and health claims for food to understand more.
Warning statements outline the potential risks associated with using a product and help the consumer decide whether they want to use the product despite the risks. The most common warning statements are the ones that list prominent allergens like Whey, Milk, Wheat, etc., on the label. Refer to this FDA Food allergen labeling guide for a detailed explanation on how you must declare allergens.
Note: Check out the complete list of warning statements that should go on your food label by looking at this CFR page.
If you’re selling cosmetics or drugs, here are a few other statements you should add to your label:
All drugs must have a statement that tells consumers how much they should consume to prevent consumers from overdosing on the product. These statements should ideally appear on the label, but if there’s no available space for the dosage statement, it can appear separately with a statement like: “See package insert for more information on the dosage.”
Although the FDA doesn’t have an acceptable list of claims a product can make, most products make claims like alcohol-free, organic, etc., on their labels. However, to ensure that your claims don’t mislead your consumers, you should check out the FDA labeling cosmetics guide.
The FDA recommends that you use warning statements wherever appropriate so that customers are informed of the potential health hazards they might have to face while using the product. Check out this CFR Cosmetic warning statements page for a detailed list of statements you should include on your labels.
Note: You can download FREE labeling checklists for cosmetics, food, and dietary supplements. Simply click the links and enter your email ID to get these checklists directly to your inbox. Now that we’ve had an overview of the labeling regulations set by the FDA let’s look at how Artwork Flow can help you adhere to these requirements.
All your team members, from the designers to the external print agency, can use this tool to check the text sizes of your logo and labels. This helps you catch errors without printing a rough draft.
Extract fonts from PDF files and check the font family and size with this tool. This is especially useful when you want to check the font sizes of the required label statements.
Extract fonts from PDF files and check the font family and size with this tool. This is especially useful when you want to check the font sizes of the required label statements.
This tool highlights the differences between two artwork versions and helps you check if corrections were made to the previous versions.
Highlights spelling errors so you can avoid a negative brand image and potential legal ramifications.
Highlights spelling errors so you can avoid a negative brand image and potential legal ramifications.
Create a set of tasks that each team member must do before sending an artwork for approval. Include all the labeling requirements in your checklist, so team members check if the artwork has all the requirements before sending it for approval.
Overall, our tools help you reduce the number of artwork revisions, increase your speed to market, and help you stay compliant.
Staying compliant can get messy as the information changes without warning, and there’s a lot of legalese involved. But creating checklists and feeding them into Artwork Flow helps create a label without many rounds of revisions and hassle.
As a result, your speed to market increases, you stay compliant, and your bottom line improves. Sign up for the 14-Day FREE trial to get started right away, or contact us if you’ve got questions.
