Product Labeling: Standards & Regulations
Marketing your products with advertising, packaging and labeling is critical for a successful business. Using untruthful or misleading claims, however, may lead to costly fines and penalties. In this article, SKS will highlight some important guidelines to consider and show you additional resources to consult for complete labeling information. For design tips, visit our Label Design Info page.
Perhaps the most important form of advertising your brand will have is your product packaging and labeling. Under the Fair Packaging and Labeling Act (FPLA), the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) publish regulations that require consumer commodities to be labeled with information disclosing net contents, product description, business name and location, etc. These agencies also regulate claims concerning ingredients and function.
FDA Guide for Labeling and Advertising
The FDA regulates food product nutritional labeling in the United States. The agency also has authority over the labeling of dietary supplements, cosmetics, and drugs (both prescription and over-the-counter) and regulates food & drug advertising.
Nutritional labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc. Food labeling for "conventional" foods such as raw fruits, vegetables and fish is voluntary. However, when ingredients such as herbs and other novel ingredients are added to conventional foods, they must either be pre-approved as a food additive or meet the requirements of the "Generally Recognized as Safe" (GRAS) provisions.
Claims that can be used on food and dietary supplement labels fall into three categories: health claims, nutrient content claims, and structure/function claims. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, or, in the case of advertising, with the Federal Trade Commission.
Two essential components:
- A substance (a food, food element, or dietary supplement ingredient)
- Its ability to reduce the risk of a disease or health condition
- Do not use heath claims unless they have been proven through testing
Dietary Guidance Statements
- Not subject to FDA review and authorization
- Must be truthful and non-misleading
- Applies to statements addressing non-specific substances as related to dietary patterns or general food categories (ex. fruits & vegetables)
Describes the role of a nutrient or dietary ingredient and how it affects normal structure or function in people ("calcium builds strong bones")
- May also describe general well being from consumption of an ingredient
- May illustrate a benefit related to a nutrient deficiency disease
- Structure/function claims are not pre-approved by FDA
- Manufacturer is responsible for ensuring the claims' accuracy and truthfulness
- Must state in a "disclaimer" that the FDA has not evaluated the claim
- Disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease"
Nutrient Content Claims
Describes the level of a nutrient or dietary substance in the product (ex. fat-free, high-fiber, low sodium)
- May also compare the level of a nutrient in a food to that of another food (reduced fat, more fiber)
- Most regulations apply only to nutrients or dietary substances that have an established daily value
- Gives consistency to illustrative terms such as high or low, making them more meaningful to consumers
- Implied nutrient content claim: healthy
- Characterizes a food with "healthy" levels of total fat, saturated fat, cholesterol and sodium
Other Food Labeling Tips
- Ingredient content must be listed from greatest to least
- Include a warning statement if product may contain common allergens
- Certain food products must be labeled with nutritional information
- List product's net weight
For more information on the FDA's regulations on food, food safety, ingredients, and packaging, visit www.fda.gov/Food.
Cosmetics & Drugs
The legal difference between a cosmetic and a drug is established according to the product's intended use. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance." Examples of cosmetic products may include:
- skin moisturizers
- fingernail polishes
- eye and facial makeup
- hair colors
- cosmetic product materials
The FD&C Act defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals."
Some products that have more than one intended use may meet the definitions of both cosmetics and drugs. For example, a shampoo is a cosmetic because it is used for hair cleansing. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Such products must comply with the requirements under both categories. Other cosmetic/drug examples include:
- fluoride toothpastes
- deodorant / antiperspirant
- sun protection makeup
This principle also holds true for essential oils in fragrance products. A perfume or cologne is a cosmetic. However, the fragrance would meet the definition of a drug if it is marketed with "aromatherapy" claims, such as asserting that the scent will help the consumer sleep or quit smoking, because of its intended use. For more information about the difference between cosmetics and drugs, click here.
Visit the FDA's Center for Drug Evaluation and Research (CDER) for information regarding laws and regulations for drugs.
Labeling Cosmetic and Bath & Body Care Products
- Ingredient content must be listed from greatest to least
- Proprietary ingredients do not need to be detailed
- Ex. List custom fragrance blends as "fragrance;" specific scent components do not need to be divulged
- Beneficial to include directions for use
Establishing Intended Use
- Claims stated on the product labeling, in advertising, or in other promotional materials
- "reduces the appearance of wrinkles", "aids cell renewal"
- Consumer perception, which may be established through the product's reputation
- why is the consumer buying the product and the consumer's expectations
- Ingredients that may cause a product to be considered a drug because they have a well known therapeutic use
- fluoride in toothpaste
The FDA does not have a definition for the term "organic." The Agricultural Marketing Service of the U.S. Department of Agriculture (USDA) oversees the National Organic Program (NOP). The NOP regulations define the term "organic" and provide certification that agricultural ingredients have been produced under specific conditions. NOP regulations also include labeling standards based on a product's organic ingredient content. Cosmetic products labeled as "organic" must comply with both USDA regulations for the organic claim and FDA regulations for labeling and safety requirements for cosmetics. For more information on "organic" labeling for cosmetics, see the NOP publication, "Cosmetics, Body Care Products, and Personal Care Products."
View the FDA's FAQ on Organic Cosmetics by clicking here. To learn more about FDA regulations concerning cosmetics labeling, product & ingredient safety, and other cosmetics resources, visit www.fda.gov/Cosmetics
Soap vs. Drugs & Cosmetics
Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because it is excluded from the definition of a cosmetic. Not every product marketed as soap meets FDA's definition of the term, which only applies when:
- The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
- The product is labeled, sold, and represented solely as soap
(21 CFR 701.20).
If a product intended to cleanse the human body does not meet all of the above criteria for soap, it is either a cosmetic or a drug. For more information, click here.
While candles do not require specific labeling, you should consider including a few basic facts in order to protect your business:
- Usage guidelines
- Never leave candle unattended, do not burn for more than 4 hours at a time, keep out of the reach of children, etc.
- Type of wax
- Soy, beeswax, paraffin
- Scent used
- Natural or artificial fragrance, essential oils
- Net weight