The U.S. Food and Drug Administration (FDA) has announced a final rule prohibiting statements on food product labels, including dietary supplements, that claim products are “high in,” “rich in,” or an “excellent source of” docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) as well as similar claims for alpha-linolenic acid (ALA). The rule finalizes a proposed rule the agency published in 2007 without any substantive changes. Under the U.S. Federal Food, Drug, and Cosmetic Act (the Act), nutrient-content claims such as “high in” are allowed only for nutrients for which a reference level for the claim has been set, or, in some situations, if the requirements of the Act have been met, such nutrient levels can be based on authoritative statements published by certain types of scientific bodies, such as the Institute of Medicine of the National Academies (IOM). FDA apparently received notifications in 2004 and 2005 asserting that IOM had…
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The National Academies’ Institute of Medicine (IOM) has issued the summary from an August 5-6, 2013, workshop titled “Caffeine in Food and Dietary Supplements.” Convened at the request of the U.S. Food and Drug Administration, workshop participants included “scientists with expertise in food safety, nutrition, pharmacology, psychology, toxicology, and related disciplines; medical professionals with pediatric and adult patient experience in cardiology, neurology, and psychiatry; public health professionals; food industry representatives; regulatory experts; and consumer advocates.” They addressed the “changing caffeine landscape” in which new food and dietary supplement products including the substance are entering the marketplace at a rapid pace and may be “targeting populations not normally associated with caffeine consumption.” Among the workshop objectives were (i) “[e]valuate the epidemiological, toxicological, clinical, and other relevant literature to describe important health hazards associated with caffeine consumption”; (ii) “[d]elineate vulnerable populations who may be at risk from caffeine exposure”; (iii) “[d]escribe caffeine…
The U.S. Food and Drug Administration (FDA) has issued two final guidance documents for industry on distinguishing liquid dietary supplements from beverages. Titled “Distinguishing Liquid Dietary Supplements From Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements,” the documents update 2009 draft guidance intended “to help dietary supplement and beverage manufacturers determine whether a liquid food product is properly classified as a dietary supplement or as a beverage, and to remind the industry of legal requirements regarding the substances that may be added to either type of product.” In “Distinguishing Liquid Dietary Supplements from Beverages,” FDA describes the factors characterizing liquid products deemed dietary supplements and those characterizing beverages deemed conventional foods. These include product claims, names, packaging, serving size, recommended daily intake, conditions of use, and product composition, as well as statements or graphic representations in labeling, advertising and other marketing practices, including promotional websites,…
A federal court in California has granted in part and denied in part the defendants’ motion to dismiss the first amended complaint in a putative class action alleging that the companies falsely label and market Splenda Essentials with Antioxidants®, Splenda Essentials with Fiber® and Splenda Essentials with B Vitamins®. Bronson v. Johnson & Johnson, Inc., No. 12-4184 (N.D. Cal., order entered April 16, 2013). Dismissed with leave to amend were claims brought under the Unfair Competition Law, False Advertising Law and Consumers Legal Remedies Act to the extent that the claims include statements made on the defendants’ website or in print ads. The court found that the plaintiffs failed to allege that they relied on these statements when purchasing the products. Also dismissed with leave to amend are claims about the Fiber and B Vitamins products because the plaintiffs relied on lack of scientific substantiation theories which cannot be asserted…
The National Toxicology Program (NTP) recently released its peer-reviewed report on the toxicology and carcinogenesis of Ginkgo biloba, “an herbal remedy and dietary supplement purported to improve memory and brain function.” Based on long-term studies in which researchers “deposited solutions of Ginkgo biloba extract in corn oil directly into the stomachs of male and female mice and rats five times a week for two years,” the report concluded that animals exposed to Ginkgo biloba extract “experienced increased rates of a variety of lesions in the liver, thyroid, and nose” as well as “increased incidences of cancers of the thyroid gland… in male and female rats and male mice and liver cancers in male and female mice.” Citing these studies, the Center for Science in the Public Interest (CSPI) has since issued a warning to consumers, advising them to avoid a number of products, including energy drinks, that list ginkgo as…
The National Toxicology Program (NTP) and the Office of Dietary Supplements are seeking information and comments on an approach document titled “Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid.” According to NTP, the information gathered through the request will be used to prioritize topics for a workshop the agency is planning “to identify research needs based on consideration of the state of the science related to the safe use of high intakes of folic acid.” Although “[t]he benefit of supplemental folic acid for pregnant women to prevent neural tube defects in their children is well established,” NTP stated, “at the same time, there is interest in understanding potential adverse health impacts from high intakes of folic acid.” The agency is specifically seeking information on the following topics: (i) “health effects of most concern for high folate intake”; (ii) “assessments of folic acid intake and folate levels…
The Council for Responsible Nutrition has issued recommended guidelines for dietary supplement products containing caffeine, including energy drink products marketed as supplements. According to the council, the guidelines expand “its self-regulatory initiatives that encourage best practices within the supplement industry and promote safe use of dietary supplements by consumers.” Council President and CEO Steve Mister said, “This is one example of how responsible companies in our industry are taking proactive steps to educate consumers so they can make informed decisions about caffeine-containing supplements, and we trust consumers will be mindful of the amounts of caffeine they are getting from all sources.” The guidelines recommend (i) the disclosure of total caffeine content for products with added caffeine in amounts more than 25 mg per serving, “declared in milligrams per serving either in the Supplement Facts Box or in a separate statement elsewhere on the label”; (ii) advisories for conditions of use,…
According to media sources, Monster Energy Corp. has announced plans to re-label its energy drinks as beverages regulated by the Food and Drug Administration (FDA) as opposed to dietary supplements. The company reportedly told industry publication Beverage Digest that it will update product labels to include “Nutritional Facts” rather than “Supplement Facts,” as well as information about the caffeine content. The change will purportedly take effect with the introduction of new products and packaging. “The Company saw no reason to continue being subjected to erroneous and misguided criticism that its Monster Energy drinks are being marketed as dietary substances to avoid FDA regulation,” read a statement that the corporation sent to ABC News. Monster Energy and other energy drink manufacturers have faced increased scrutiny and litigation over claims allegedly linking the products to fatalities in susceptible individuals. Additional details about ongoing investigations by FDA and members of Congress appear in…
Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have reportedly called for a meeting with Food and Drug Administration (FDA) Commissioner Margaret Hamburg after reports surfaced that the agency has received adverse event reports indicating that the caffeinated energy supplement 5-Hour Energy® may have been linked to the deaths of 13 people in the past four years. The product has apparently been mentioned in 90 filings submitted to the agency; the reports include more than 30 that purportedly involved serious injuries such as heart attacks, convulsions and a spontaneous abortion. The senators have questioned the safety of energy drinks in three letters to the agency in recent months; their latest letter states, “[W]e request a meeting with you on the steps FDA is taking regarding highly caffeinated energy drinks and to ensure they are safe for their intended use and in combination with other energy drink ingredients.” The senators also…
Part II of the American Bar Association’s (ABA’s) Nanotechnology Project, this recently released book comprehensively considers, by product category, how the Food and Drug Administration (FDA) reviews nanotechnology-based products. Shook, Hardy & Bacon Agribusiness & Food Safety Attorney James Andreasen was among those practitioners contributing to the work. Among the chapters are “Color Additives,” “Food Additives and Related Substances,” “Dietary Supplements,” “Food and Animal Feed Products,” and “Biological Products.” They address “how FDA can, and to some extent, has, regulated nanomaterials in products falling under its multiple areas of responsibility,” and (i) identify “products that already feature nanomaterials”; (ii) review “FDA’s regulatory program for the specific product category (such as particular pre-market and post-market controls)”; and (iii) discuss “how that program might apply to nanomaterials.”
