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Comments on the U.S. government’s position concerning draft vitamin and mineral supplement guidelines before the Codex Committee on Nutrition and Foods for Special Dietary Uses.

We take this opportunity to voice our support of comments submitted by the Council for Responsible Nutrition (CRN) regarding the appropriate interpretation of the term “chemically altered” under Section 413(a)(1) of the Federal Food, Drug, and Cosmetic Act.

Enclosed are comments on the recent notice from the California Office of Environmental Health Hazard Assessment regarding 22 chemicals to be discussed at a meeting of the Developmental and Reproductive Toxicant Identification Committee. These comments address manganese.

CHPA believes that FDA’s revised 2016 Draft Guidance is an important step in helping to improve manufacturer understanding of, and compliance with, the new dietary ingredient notification requirement in Section 413 of the Federal Food, Drug, and Cosmetic Act.

CHPA supports rules governing the regulation of dietary supplements as a special type of food. The association has long advocated Good Manufacturing Practices for dietary supplements.

The industry favors and supports the development of reasonable guidance. However, the agency’s attempt to redefine the NDI notification process contradicts the letter and spirit of DSHEA. The Draft Guidance would undo nearly two decades of agency practice and policy.

We take this opportunity to voice our support of comments submitted by the American Herbal Products Association regarding proposed revisions to the agency's Draft Guidance on New Dietary Ingredient Notification.

Echoing earlier comments submitted to the agency, CHPA and its member companies marketing dietary supplement products support the presumption of safety for dietary ingredients outlined in the 1994 passage of DSHEA.

CHPA appreciates that FDA has taken the time to review the data associated with certain isolated or synthetic carbohydrates not listed as a dietary fiber and looks forward to engaging with FDA in efforts to clarify and improve the regulation of all dietary supplements.