FDA issues final guidance distinguishing liquid dietary supplements from beverages
SILVER SPRING, Md. — The Food and Drug Administration earlier this week issued final guidance for the industry on distinguishing liquid dietary supplements from beverages. "We are issuing this guidance to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage," the agency stated. "This guidance describes the factors that distinguish liquid products that are dietary supplements from those that are conventional foods."
According to the FDA, the most obvious representations about a product’s use are claims made for the product in its labeling and advertising. "However, a product’s name, packaging, serving size, recommended daily intake and other recommended conditions of use and composition, as well as marketing practices and representations about the product outside its labeling and advertising, can also be important determinants of whether the product is represented as a conventional food (and, thus, may not be marketed as a dietary supplement)," the agency wrote. "Although in some circumstances a single factor may be determinative of whether the product is represented as a conventional food, … in most circumstances a combination of factors would determine whether the product is represented as a conventional food."
The following is a run-down of the differentiators, as defined by the FDA:
- Labeling and advertising: Generally, products that bear statements that the product is intended to “refresh” or “rehydrate” represent the product for use as a beverage, i.e., a conventional food;
- Product name: Product or brand names that use such conventional food terms as “beverage,” “drink,” “water” or “soda” represent the product as a conventional food;
- Product packaging: Packaging characteristics that should be considered include the size, shape, color and design of the container or other packaging, the volume of liquid it holds, whether it is reclosable or designed to be consumed in a single serving, and the similarity of the packaging to packaging used for common beverages;
- Serving size and recommended daily intake: Liquid products that suggest through their labeled serving size and/or recommended daily intake (e.g., “Drink up to three 16-ounce bottles per day”) that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the United States are effectively being represented as conventional foods;
- Composition: Adding common dietary supplement ingredients to a beverage does not make it a dietary supplement per se. Products that are consumed primarily for taste rather than nutrition or health-related purposes are beverages;
- Other representations about a product: Other representations about a product include, for example, representations in publicly available documents, such as statements made in filings with government agencies such as the U.S. Securities and Exchange Commission or the U.S. Patent and Trademark Office.
"FDA intends to consider all relevant factors in context when determining whether a product is represented as a conventional food," the agency stated.
Clif Bar adds two flavors to its Luna Protein line
EMERYVILLE, Calif. — Clif Bar on Tuesday announced two new flavors to its Luna Protein line — lemon vanilla and chocolate coconut almond. Lemon vanilla is the first Luna Protein bar without a chocolate coating.
“We realize that women are constantly on-the-go and may not have time to sit down and enjoy a protein-filled meal; they need a go-to snack that is nutritious and will keep them satiated,” said Tara DelloIacono-Thies, manager of nutrition strategy for Luna. “This is where Luna Protein comes in. We want women to have a nourishing and tasty option when they need it," she said.
“The amount of protein women need depends on their activity level,” DelloIacono-Thies said. “I recommend women use the following basic formula to determine how much protein they should have each day to keep them going strong:"
- Spends most the day sitting: Weight in pounds x 0.4 = grams of protein/day;
- Physically demanding job and regularly active: Weight in pounds x 0.6 = grams of protein/day;
- Competitive athlete: Weight in pounds x 0.75 = grams of protein/day.
The Luna Protein line first launched in 2010 to help women more easily fit protein into their diet. With Luna Protein Lemon Vanilla and Chocolate Coconut Almond, Luna continues its dedication to provide women with a wide array of snacks that have the nutrition they need in the flavors they crave.
The new Luna Protein bars will sell for a suggested retail price of $1.39.
NAD refers ad claims made by Coorga Nutraceuticals for its Grey Defense dietary supplements to FTC
NEW YORK — The National Advertising Division on Tuesday referred advertising claims made by Coorga Nutraceuticals Corp. for its Grey Defense dietary supplements to the Federal Trade Commission.
NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.
NAD had requested substantiation for advertising claims that included “Reverse Grey Hair in 6 Months”; “Try Grey Defence Xtreme for 6 months, if the results don’t amaze, we’ll give you your money back”; “Grey Defence is a super-premium dietary supplement that is formulated to assist the body in reversing gray hair due to oxidative stress”; and “Grey Defence neutralizes hydrogen peroxide on contact, helping to slow, stop and reverse grey hair due to oxidative stress.”
The company, in response to NAD’s inquiry, declined to participate in the self-regulatory process. The advertiser noted that its decision was rooted in its concern about publicly disclosing the research upon which the company relies to support its advertising claims.
NAD was disappointed that the advertiser declined to participate in the self-regulatory process, the agency noted. In light of the advertiser’s position, NAD, pursuant to Section 2.9 of the NAD/NARB Procedures, referred this matter to the FTC for possible law enforcement action.