Comments and Testimony
Seeking to safeguard access to natural food, products and services and preserve the integrity of the current organic standards, the Organic & Natural Health Association advocates with all branches of state and federal government. Below, please find official advocacy communications submitted to various government agencies and Congress by O&N.
In response to FDA’s request for comments on the Draft Guidance for New Dietary Ingredients, the Organic & Natural Health Association asserts that the process, as articulated, does nothing to support or enhance the documented safety record of the dietary supplement industry. In fact, the advancements gained in the market since the passage of DSHEA in 1994 rendered the administrative complexity of this Draft Guidance obsolete upon its release.
In response to FDA’s request for comments on defining the term “natural,” the Organic & Natural Health Association submitted the results of its consumer research survey conducted in January 2015, which concluded consumers do in fact perceive “organic” and “natural” to be substantially equivalent. It is the position of the Association that any potential standard developed for natural exceed the government’s organic criteria.
This petition is submitted under 21 C.F.R. § 10.30 on behalf of the Organic and Natural Health Association (“ONHA”) to request the Commissioner of Food and Drugs to amend 21 C.F.R. Part 111, the current good manufacturing practice (“CGMP”) regulations governing dietary supplements (“Part 111”), to include persons who manufacture, process, package, or hold finished dietary ingredients (“dietary ingredient suppliers”). We also request that the FDA clarify the regulatory responsibilities of private label distributors under Part 111.
In July 2014, the Organic & Natural Health Association submitted comments to the FTC in support of the claims made by iHealth, Inc. and Martek Biosciences Corp., that the dietary supplement BrainStrong™ Adult improves memory in adults or prevents cognitive decline. Further, O&N requested the FTC withdraw their Proposed Settlement against iHealth and Martek.