Author

Anna Benevente

Director of Labeling, Ingredient and Product Review

5 FDA Weight Loss Label Violations

Apr 13, 2022

Obesity and overweight are health conditions that plague millions of people in the United States. Products marketed for weight loss contain ingredients that claim to help consumers lose weight in different ways, depending on the type of product. The types of claims that can be made about a product are impacted significantly by its classification as a drug, device, conventional food, or dietary supplement. While the U.S. Food and Drug Administration (FDA) regulates weight loss drugs and medical devices more stringently than food products, all of these products must adhere to certain FDA label regulations.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

Get Assistance

FDA considers multiple aspects of a product (including its classification) to determine the applicable labeling regulations. Read more to learn about label violations frequently associated with weight loss products..

1. Drug Claims On Conventional Foods and Supplements

Conventional food products claiming to help with weight loss are common in the U.S. A label can suggest the product may help with weight loss, but claims must be carefully worded to avoid stating that the product will help treat obesity or any other weight-related condition. Such claims would suggest the product is a drug and would make the product subject to drug regulations.Weight loss claims that are acceptable include phrases such as, “guilt-free” or “diet-friendly”. Additionally, labels often describe possible weight-reducing properties of key ingredients, as opposed to making a claim about the product itself. For example, the label for a product containing whole grains might state that whole grains can help consumers to feel fuller longer, suggesting the food can help consumers manage their appetites. Weight loss claims on conventional foods must be based upon nutritive aspects of the product.Weight loss products can also come in the form of supplements. FDA does not approve supplements, including those that are marketed as weight loss products. Claims on supplements can be based upon nutritive and non-nutritive aspects of the product, but are subject to the same labeling restrictions as conventional foods that prohibit claims suggesting a product can treat a health condition.

2. Nutrient Content Claims

Labels on weight loss food products often emphasize certain aspects of the product’s nutrient content. FDA allows companies to place certain statements about the nutrient content on labels, but only if the claims meet certain criteria. For example, to include the statement “calorie-free”, FDA requires that the product contain less than 5 calories per reference amount customarily consumed, whereas “low-calorie” indicates less than 40 calories per reference amount.FDA has guidelines for other nutrient claims as well, and failure to meet requirements while making certain claims could lead to a product being misbranded.

3. Hidden Ingredients

In some cases, FDA may issue a public warning about products that contain hidden ingredients not listed on the label. In 2021, FDA purchased and tested a weight loss supplement that was sold online. The tests concluded that the supplement contained unlisted ingredients, some of which were ingredients found in prescription drugs. FDA released a public notice detailing FDA’s findings and the potential health risks buyers could face if they consumed the supplement.

4. Inadequate Directions

While conventional foods and supplements are marketed without any prior FDA approval, weight-loss products in the form of a drug or medical device often must go through FDA’s premarket notification or approval process. FDA’s clearance or approval of a drug or medical device indicates that the Agency has reviewed the product and deemed that the benefits outweigh its known and potential risks for the intended population.Drug and medical device labels must bear adequate directions for use, including warnings regarding unsafe dosage, methods, or duration of administration or application. Labels must also indicate whether the drug or medical device might be unsafe for children or those with pathological conditions. Omission of necessary directions may result in the product being misbranded.

5. Misleading Claims on Promotional Material

While FDA allows companies to alter the language of a compliant label to better fit the audience for promotional advertising, certain information needs to be included across all avenues of promotion. If required information is omitted or incomplete, FDA may conclude the promotional message to be false or misleading.In a Warning Letter to Nalpropion Pharmaceuticals LLC, FDA stated that performing an internet search for one of the company’s products generated a sponsored link that was misleading about the product’s risks and efficacy. The label on the product was FDA-compliant, but FDA considered the product to be misbranded due to false or misleading claims within the text of the sponsored link.As Warning Letters and other enforcement actions could result in reputation damage for a company, firms should be consistent with listing required information when marketing their products.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

Get Assistance

Author


Anna Benevente

Director of Labeling, Ingredient and Product Review

Highly regarded as a top expert on FDA labeling regulations, Anna Benevente continues to educate companies on existing regulations and updates from U.S. FDA for food and beverage, cosmetic, drug, and medical device products. She has researched thousands of products to determine whether they meet the FDA requirements for compliance. In addition, Ms. Benevente has conducted multiple seminars for trade and customs broker associations.

Related Article


Subscribe To Our News Feed

To top
This site is registered on wpml.org as a development site. Switch to a production site key to remove this banner.