Author

Anna Benevente

Director of Labeling, Ingredient and Product Review

Author

5 Reasons FDA Will Detain Imports of Holistic Products

Mar 23, 2022

Products marketed as “holistic” have become increasingly popular in the United States. With more people aiming to incorporate natural products into their lifestyle, companies are striving to meet the demand. Holistic products come in many forms, from detox teas and skin creams to dietary supplements and weight-loss pills.

FDA does not regulate the use of the term “holistic”. It is largely a marketing term intended to signify a natural product manufactured with minimal processing. Although FDA does not regulate the term, products marketed as holistic are subject to the same FDA regulations as other products. If you are shipping a holistic product to the U.S., complying with FDA’s regulations can help prevent costly detentions.

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.

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Keep reading for compliance issues to avoid when preparing products marketed as holistic.

Unauthorized Health Claims

Consumers often purchase holistic products believing the products can reduce the risk of disease or a health-related condition. However, to market health claims on food or dietary supplement labels, establishments must prove to FDA that the health claims are substantiated. If a product bears labeling with health claims that FDA has not authorized, the product may be detained for misbranding or adulteration.

FDA may authorize a health claim if scientific evidence exists that validates the correlation between the substance and the health-related condition. Once authorized, FDA codifies it in regulation, and any product that meets the conditions may use the claim. If a claim has not been authorized, a petition must be filed with FDA. Any interested person may petition FDA to issue a regulation to authorize a specific health claim. Qualified experts review the petition and must reach an agreement that all publicly available scientific evidence supports the relationship between the health-related condition and the substance.

Missing Statement of Identity

All conventional foods and dietary supplement products must include a statement of identity on the label. For conventional foods, this is usually the “common or usual name” for the product, such as “green tea.” Dietary supplements have a different set of requirements for the statement of identity. FDA and the Federal Food, Drug, and Cosmetic Act require supplements to bear labeling that specifies the statement of identity “dietary supplement” (which may be modified to replace “dietary” with the name of the ingredient(s)). Firms must place the statement of identity on the principal display panel (PDP) of the product and any alternate PDPs. The statement of identity must be in bold print, separate from the brand name, and prominently featured on the label.

Missing “Supplement Facts” Panel

Supplements must bear a Supplement Facts panel that serves as the product’s nutrition label. The Supplement Facts panel must include, among other things, the common names and quantities of dietary ingredients and the serving size of the supplement. The panel must also include servings per container if this information is not conveyed by the net quantity statement.

FDA requires certain nutrients to be listed on the Supplement Facts panel if the amount in the product exceeds established levels of significance. FDA requires that you declare the amounts of 15 established mandatory nutrients (if present) and any other “dietary ingredients” (such as an omega fatty acid) that are present in the product.

Undeclared Ingredients

FDA requires manufacturers to list all ingredients included in a food product on the product’s label. If FDA inspects an imported product and determines that there are undeclared ingredients, FDA may place the product on Import Alert. Products on Import Alert are subject to Detention Without Physical Examination (DWPE) and FDA may refuse entry to the shipments unless the importer can prove that the products do not include undeclared ingredients. Products that are refused entry must be destroyed or re-exported out of the U.S.

Label Not in English

FDA requires that all mandatory words, statements, and other information on labels appear in English. A label may include other languages along with English, but if any of the mandatory labeling information (such as the product name or ingredients list) is present in a foreign language, all of the required information on the label must appear in that language as well.

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.

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