HEALTH

CRN urges FDA to reconsider provisions in New Dietary Ingredient Draft Guidance

BY Michael Johnsen

WASHINGTON — The Food and Drug Administration’s New Dietary Ingredient Draft Guidance should not give the agency pre-market approval over new dietary supplement products, the Council for Responsible Nutrition claimed Monday in a commentary published in Regulatory Toxicology and Pharmacology, the official journal of the International Society of Regulatory Toxicology and Pharmacology.

“The draft guidance attempts to apply the notification requirement to new supplements, not just new ingredients, and it expands the working definition of ‘chemically altered’ to include many changes that were not foreseen in the Congressional Record in 1994,” wrote the commentary’s co-authors Steve Mister, president and CEO of CRN, and John Hathcock, SVP international and regulatory affairs for CRN. “Through these misinterpretations, [the] FDA attempts to impose a food additives-like safety standard and gain de facto pre-market approval against the overt wishes of Congress.”

According to the CRN, the FDA includes the following provisions in its NDI Draft Guidance that effectively would impose a pre-market approval restriction:

  • Recharacterizing many existing dietary ingredients as new dietary ingredients by expanding the definition of “chemically altered” to classify innovations in manufacturing as being chemical alterations;

  • Requiring physical proof with “material evidence” that an ingredient actually was available in the market before 1994, and thus exempt from the NDI requirements;

  • Prohibiting bio-identical synthetic versions of botanical compounds from being classified as dietary ingredients at all;

  • Requiring a separate notification for each new product, as opposed to just the dietary ingredient; and

  • Declaring The Redbook, the official textbook for evaluating food additives, which has a “significantly higher threshold” for safety than the “reasonable expectation of safety” established under DSHEA, as “authoritative for demonstrating the safety of NDIs.”

“It is time for [the] FDA to reconsider its efforts to redistribute the safety burdens allocated by Congress in DSHEA, and to recognize that the pre-market paradigm of food additives is not what Congress intended for dietary supplements,” CRN concluded.


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NAD refers company making unsubstantiated disease-state claims to FTC

BY Michael Johnsen

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Monday referred advertising for Serranol dietary supplement, marketed by Good Health Naturally, to the Federal Trade Commission for further review after the company declined to fully participate in a National Advertising Division review of its advertising claims.

As part of an initiative to expand the review of advertising claims made for dietary supplements, the Council for Responsible Nutrition challenged advertising claims made for the product, which included advertising the health benefits of the ingredient ecklonia cava extract for people who suffer conditions that included fibromyalgia, vascular inflammation, atherosclerosis, cardiovascular conditions, high cholesterol, high blood pressure, anticlotting disorders, memory disorders, brain function disorders, joint and nerve pain, allergies, COPD, obesity, diabetes or penile dysfunction.

CRN also challenged safety claims concerning the product.

The NAD recommended that the advertiser discontinue many of the challenged claims because it did not conduct any studies on the Serranol product itself and because it provided only animal studies, informal summaries, abstracts or bibliographic references in support of the majority of its ingredient claims.

The NAD determined that the very few in vitro and in vivo full-text studies submitted by the advertiser were insufficient to support the advertiser’s strong health claims, and determined that the advertiser did not produce any evidence to support its safety claims, although the advertiser is free to tout that ECE is an edible brown algae.

The advertiser failed to submit a statement that it would comply with NAD’s recommendations. As a result, NAD has referred the advertising claims at issue to the FTC for further review.


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Idaho joins National Precursor Log Exchange in its fight against PSE diversion

BY Michael Johnsen

WASHINGTON — Idaho on Monday became state No. 21 to adopt the real-time, stop-sale technology National Precursor Log Exchange in its battle against the diversion of the cough-cold ingredient pseudoephedrine to methamphetamine.

"Idaho has taken an important step in the battle against methamphetamine by adopting a proven system that provides law enforcement with an invaluable tool to track criminal activity and bring meth dealers and producers to justice," stated Scott Melville, president and CEO of the Consumer Healthcare Products Association. "In addition to aiding police officers, NPLEx allows retailers to block unlawful pseudoephedrine purchases right at the sales counter, and just as importantly, it protects law-abiding consumers’ access to the cold and allergy medicines they depend on for relief."

NPLEx is funded by manufacturers who are members of CHPA as the industry solution to combating PSE diversion. NPLEx provides a secure, interconnected electronic logbook that tracks and logs every PSE sale in every store at the precise moment it is happening. When a purchase is made, the logbook advises retailers when to refuse a sale based on an individual’s purchase record elsewhere in the state and beyond its borders. The system also provides law enforcement officials with a tool in the fight against meth as the only system that can block the illegal sale in real time and across state lines.

Idaho Gov. "Butch" Otter signed the legislation — Senate Bill 1309 — which originally was introduced by Sen. Joyce Broadsword, R-Dist. 2.


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