KKB assists trade association in drafting small business provisions of the Family Smoking Prevention and Tobacco Control Act, and counsels on compliance with the Act

A trade association of small tobacco manufacturers and importers sought assistance in drafting provisions for inclusion in the Family Smoking Prevention and Tobacco Control Act (TCA). KKB worked with the member companies to draft provisions that would protect the interests of small businesses, and counseled the members regarding submitting the draft provisions to their legislators ...full story

KKB assists client in approval of meat and poultry ingredient by USDA

A client that manufactures meat products wished to include in its products an ingredient that had not yet been approved by USDA for use in meat products. The approval of an ingredient in a meat product is generally a two-step process: (1) FDA reviews a GRAS (generally recognized as safe) notification submitted by the manufacturer and then if FDA has no issues regarding the safety of the product ...full story

KKB assists foreign client in labeling, advertising, and importation of large line of dietary supplements, cosmetics, and foods

A foreign client sought advice in developing compliant labeling and advertising for its large line of dietary supplements, cosmetics, and foods marketed to Spanish-speaking consumers in the U.S. KKB worked with the client for several years to ensure that labels and promotional materials (including website material) for new and existing products are consistent with FDA and FTC requirements ...full story

KKB assists client in obtaining an FDA "no questions" letter for a GRAS food ingredient

A client that makes functional ingredients for the food and dietary supplement industry sought the strongest possible statement by FDA in support of the use of its ingredient in conventional foods. KKB recommended that the company evaluate the general recognition of safety of the ingredient and, if supported by the scientific evidence, reach a determination that the ingredient is "generally recognized as safe" (GRAS) for its intended use in food. ...full story

KKB continues to lead in the field of health claims for foods

KKB has helped food industry clients make health claims for foods since the field first opened up in the US in the late 1980s. For example, working with a client, we helped lead the petition process for one of the first FDA-approved health claims - the claim for phytosterols and reduced risk of heart disease, in 2000. More recently, FDA fully accepted another petition prepared by KKB on phytosterols. The petition urged FDA to accept 2 grams of phytosterols ...full story

KKB assists client in successfully challenging advertising before the National Advertising Division (NAD) of the Council of Better Business Bureaus

Our client sought advice on the merits of a potential challenge to several promotional claims for a competing beverage product. KKB evaluated the advertising claims, identified vulnerabilities in the claims, and assisted in preparing a submission to the NAD challenging the accuracy of the claims. We prepared a detailed rebuttal to the advertiser's submission to the NAD, including a critique of the physician survey relied ...full story

Defending a food advertising challenge before the National Advertising Division (NAD) of the Council of Better Business Bureaus

A competitor brought an NAD advertising challenge to comparative nutrition claims made in a series of advertisements for our client's food product. The central dispute between the parties was whether there was a meaningful nutritional difference between our client's product and the product that was the target of the comparative claims. There was also disagreement as to the messages conveyed by the challenged advertisements ...full story

Successful defense to a dietary supplement advertising inquiry from the Electronic Retailing Self-Regulation Program (ERSP)

We were retained to defend an ERSP inquiry into the support for a number of dietary supplement advertising claims, including several strong and specific performance claims. KKB reviewed available clinical studies and other scientific and technical information potentially supportive of the claims, and developed a strategy for responding to the inquiry. We worked directly with the client's outside scientific expert to prepare a statement describing the competent and reliable scientific evidence supporting the claims ...full story

New Requirements In Recent FTC Food & Dietary Supplement Orders

This year, through its Consent Orders and presentations by its Bureau Director and senior staff, the Federal Trade Commission (FTC) has begun to provide more concrete guidance to the food and dietary supplement industries on what is required to adequately substantiate health benefit claims. ...full story