Supplements

FDA does not have a formal definition for what this claim means, but it has acknowledged a “longstanding policy” concerning the use of the word “natural” in food labeling. FDA considers it to mean that nothing artificial or synthetic (including color additives) has been included in or added to a food if it would not normally be expected to be found in that food. FDA also states the use of the word “natural” currently does not address food production or processing methods, such as the use of pesticides, thermal technologies, pasteurization, or irradiation. FDA has not considered whether “natural” describes nutritional benefits.

Dietary supplement labels may include cautionary statements, but the absence of one does not mean that there are no adverse side effects associated with the product. More information is available in this FDA guidance document.

Dairy Free

This term is not specifically regulated. But, like all label claims, the claim “dairy free” cannot be false or misleading. Additionally, milk ingredients need to be disclosed under the Food Allergen Labeling and Consumer Protection Act of 2004. The FDA does regulate the similar “non-dairy” claim.

Non-Dairy

Non-dairy foods may be made from animal proteins and contain milk products. When “non-dairy” labeled foods contain a caseinate ingredient (milk protein), the caseinate ingredient must be followed by a statement identifying its source. “For example, if the manufacturer uses the term ‘non-dairy’ on a creamer that contains sodium caseinate, it shall include a parenthetical term such as ‘a milk derivative’ after the listing of sodium caseinate in the ingredient list.” See FDA regulations for more information.

A dietary ingredient is a vitamin, mineral, herb, botanical, amino acid, or any other dietary substance intended for use by humans to supplement the diet. It can also be any concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients. For more information, the statutory definition see here. Additional information is also available in this FDA guidance document.

The FDA defines the term “dietary supplement” as “a product taken by mouth that contains a dietary ingredient intended to supplement the diet.” A dietary supplement often comes in the form of a pill, liquid, or powder. They can also be in other forms like a bar, if the product does not represent itself as a “conventional food or a sole item of a meal or diet.” For more information see FDA Regulations.

FDA warns to watch out for claims such as “quick and effective,” “cure all,” or “totally safe.” These labels are not regulated by FDA and before consuming products with these labels, one should consult with a health professional.

FDA does not “approve” dietary supplement facilities or manufacturers. FDA does regulate manufacturing practices and has the authority to regularly inspect facilities to ensure they are in compliance with the law. However, these inspections do not result in a certification of “FDA Approved,” and there is no official seal for products to indicate that they are produced in a facility that is in compliance with FDA regulations.

If an ingredient is present in any amount that cannot be declared as zero then it is present in a measurable amount. For example, if dietary fiber is present in an amount greater than 1 gram, it is present in a measurable amount. If there are fewer than 5 calories, then a label may read zero calories. For more information on measurable amounts see FDA regulations.

This label indicates that a manufacturer did not add any sugars to the product during processing. It does not mean that there is no sugar in the product, and the product could still contain naturally occurring sugars. See FDA regulations for more information.

This term includes dietary ingredients that have recommended daily intakes or daily recommended values; this term is listed in the Supplement Facts panel following the list of dietary ingredients with daily values. More information is available in the FDA Dietary Supplement Labeling Guide.

Over-the-counter supplements can never be “pharmaceutical strength.” A supplement of the same strength as a pharmaceutical substance would be considered a drug, and subject to additional regulations.

This label indicates that the manufacturer has mixed several ingredients into a blend used only by that manufacturer, and the manufacturer does not need to state exactly how much of each ingredient is included. However, the ingredients will still be listed in order of the amount that the product contains. Proprietary blends are discussed further in FDA regulations.

The serving size for a dietary supplement is the maximum amount recommended on the label for consumption per eating occasion. FDA designates the serving size and label statement units for specific foods as well as larger categories of foods. If there is no recommendation, then the serving size is one unit, which could mean anything from one tablet to a spoonful of the contents of the container. Whichever unit is decided must be included on the label. If the recommended serving size is a range (1-3 tablets, for example) then the serving size is the upper end of that range (3 tablets). For more information on serving sizes, see FDA regulations. More information is available in this FDA guidance document.

The term “soy free” is not specifically regulated. However, under the Food Allergen Labeling and Consumer Protection Act of 2004, producers must include on the label whether the product contains a major food allergen, including soy.

A label that indicates what a product is supposed to do is referred to as a structure/function claim. A structure/function claim describes the role of a nutrient “intended to affect the normal structure or function of the human body.” FDA does not allow supplement manufacturers to make claims about a product’s ability to actually treat or prevent disease, so companies tend to stick to these more general claims about health. The manufacturer must submit proof that the claim is truthful and not misleading to FDA within 30 days of marketing the supplement. Additionally the label must include a disclaimer that FDA has not evaluated the claim. “The disclaimer must also state that the dietary supplement product is not intended to ‘diagnose, treat, cure or prevent any disease,’ because only a drug can legally make such a claim.”

This term means that a product has been produced according to the standards in the Organic Foods Production Act (OFPA) and certified by USDA’s National Organic Program. A label may only use the “USDA Organic” seal if the food is actually certified organic.

Organic products are grown and processed according to federal standards on soil quality, pest and weed control, and use of chemical fertilizers, among other areas. According to USDA, “[o]rganic producers rely on natural substances and physical, mechanical, or biologically based farming methods to the fullest extent possible.”

The amount of organic ingredients in a food matters for labeling. A “100 percent organic” product may only have ingredients that are organic. A food that has at least 95 percent organic ingredients may have the term “organic” on its label if the organic ingredients are specifically noted somewhere on the package. For more information on organic ingredient labeling, see the USDA Organic Labeling Standards website.

FDA does not define this term, but it is generally used to mean foods made without any animal products like milk, honey, whey, or eggs. Vegan Action is a third-party organization that certifies products that do not contain animal products or byproducts and have not been tested on animals.