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Trade Organizations, Court and Government Actions Affect Herbal Industry

ISSUE:
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62

Trade Organizations, Court and Government Actions Affect Herbal Industry

by Mark Blumenthal

AHPA Announces Self-Regulatory Policies on Herb Safety Labeling and Patient Disclosure of Herb Use

In October 2001 the American Herbal Products Association (AHPA) released new self-regulatory policies and positions recently adopted by its board of trustees. First, AHPA adopted the Healthcare Provider Communication Policy, recommending that herbal supplement users inform their healthcare providers what supplements they are taking. AHPA encourages healthcare providers of all disciplines to educate themselves on therapeutic aspects of botanicals (both risks and benefits) in order to be more receptive to patients' alternative healthcare choices.

Secondly, AHPA recommended that products containing herbs listed in the organization's Botanical Safety Handbook, under class 3 (herbs whose safety requires that they be dispensed by a practitioner only), should carry "appropriate cautionary information on the label, including dosage, contraindications, potential adverse effects and drug interactions" on the label. Class 3 herbs include belladonna, mandrake and digitalis. AHPA also advised that Class 3-containing products should be labeled as "not for general retail sale."

[Natural Products Industry Insider, 2001 Oct 15.]

GAO Issues Report on Health Products for Seniors and Senate Committee Holds Related Hearing

The U.S. General Accounting Office (GAO) issued a report in September that expressed concern for "health products" that "have health risks or are marketed with misleading and unsubstantiated claims." The report, Health Products for Seniors: "Anti-Aging" Products Pose Potential for Physical and Economic Harm, was prepared by GAO at the request of Sen. John Breaux (D-LA), Chairman of the Senate's Special Committee on Aging. The Committee held an investigative hearing intended to "educate older Americans to be aware of fraudulent marketing tactics when considering supplement purchases."

Entitled "Swindlers, Hucksters and Snake Oil Salesmen": The Hype and Hope of Marketing Anti-Aging Products to Seniors, the hearing included testimony by representatives of the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Federal Bureau of Investigation (FBI), the GAO, and representatives from several manufacturers.

Sen. Breaux expressed his belief that "the vast majority of manufacturers and marketers of dietary supplements are reputable and law abiding" and stated that the concern of the hearing was with the "bad actors." Breaux directed pointed questioning, however, at the regulatory bodies and their view of the impact of the Dietary Supplement Health and Education Act (DSHEA), saying, "'it seems to me that DSHEA has greatly hamstrung" enforcement and asking representatives from both FDA and FTC whether the passage of DSHEA in 1994 has made their jobs easier or more difficult.

Howard Beales, Director of FTC's Bureau of Consumer Protection, unequivocally responded that DSHEA has not made any significant difference in enforcement at that agency, and that FTC continues to emphasize substantiation of claims, just as it did prior to the passage of the act in 1994.

However, John Taylor, Director of FDA's Office of Enforcement criticized perceived flaws in DSHEA: (1) that manufacturers are not required to register with FDA, so that the agency finds it "difficult to identify all of the sources" of supplement products; (2) that adverse event reporting is voluntary; (3) and that DSHEA's placement of the burden of proof on FDA to substantiate its actions in the removal of an unsafe dietary supplement ingredient "makes it much more challenging to bring enforcement action" against supplement companies.

Much of the hearing was focused on one particular company, Gero Vita International, of Toronto, and the claims that company makes for its products. Two Gero Vita executives, reportedly pleaded the Fifth Amendment in response to some of the panel's questions.

The GAO report can be downloaded at <http://www.gao.gov> by searching for report number GAO-01-1129. Testimony provided at the Aging Committee hearing can be found at <http://aging.senate.gov/events.htm>.

In a related development the Dietary Supplement Education Alliance (DSEA) issued a press release accentuating the most recent scientific studies that have concluded that supplements are essential to the health of senior citizens. It is available online at <http://www.supplementinfo.org>.

[AHPA Update. American Herbal Products Assn. 2001 Sept 13.]

Herb Industry Members Win California Prop 65 Case:

Alcoholic Herbal Extracts Not a Health Problem

In what the herb industry has termed a significant victory for the "rational interpretation" of California's Proposition 65, California Superior Court Judge William Highberger on October 15 threw out lawsuits against manufacturers of liquid herbal products. The suits had insisted that the herbal tinctures and extracts sold by these companies are "alcoholic beverages," and accused them of failing to provide sufficient information to consumers as required by Prop 65.

The plaintiff was the State of California whose complaint was based on the position that the presence of alcohol in liquid herbal extracts renders them alcoholic beverages. Proposition 65 maintains a list of chemicals, including "ethyl alcohol in alcoholic beverages," that requires a warning to consumers of the possibility of birth defects. However, the list does not include ethyl alcohol itself. While the Judge agreed that "such listings should be read broadly," he went on to say, "But 'broad' reading does not equate to 'absurd' reading," referring to the relatively small amount of alcohol ingested with normal use of herbal extracts compared to conventional alcoholic beverages.

Michael McGuffin, American Herbal Products Association (AHPA) president, said, "Judge Highberger's decision provides meaningful assurance to manufacturers and consumers alike that properly labeled herbal products in this form will continue to be available to promote the health of Californians."

Those wanting further information, or a copy of the Court's finding can contact McGuffin at AHPA via email at <mmcguffin@ahpa.org>.

[AHPA Update. American Herbal Products Assn. 2001 Oct 22.]

FDA Clarifies Position on Marketing "PA-free" Comfrey Products

The U.S. Food and Drug Administration (FDA) has responded to a letter sent by the American Herbal Products Association (AHPA) on July 31, 2001, in which the trade organization requested that the agency clarify its position expressed in a letter to industry on July 6, 2001, about the marketing of comfrey products, including products that do not contain pyrrolizidine alkaloids (PAs).

FDA stated in its July 6 letter that it was issued "to communicate our concern about the marketing of dietary supplements that contain the herbal ingredient comfrey (Symphytum officinale (common comfrey), S. asperum (prickly comfrey), and S. x uplandicum (Russian comfrey)," as these plants are sources of PAs "that present a serious health hazard to consumers when they are ingested." In its July 31 letter, AHPA told FDA that "there are comfrey cultivars that are very low in or devoid of pyrrolizidine alkaloids and that there are processing technologies that allow removal of these alkaloids from comfrey." AHPA stated that it is aware that certain of its members market dietary supplement products that contain these ingredients (i.e., "PA-free products"), and requested that FDA clarify its position regarding the marketing of PA-free products. AHPA also asked the FDA to specify a specific minimum level of pyrrolizidine alkaloids for such products.

In November AHPA received the following response from FDA:

PA-free products may be marketed:

FDA expressed an understanding that "the principal safety concerns" associated with the consumption of comfrey are related to the pyrrolizidine alkaloids, and stated, "We would not necessarily object to the marketing of dietary supplement products containing dietary ingredients that had been processed to remove the pyrrolizidine alkaloids," so long as the manufacturer "can ensure, using validated analytical methods, and through good manufacturing practices, that each batch of product produced is pyrrolizidine alkaloid free '."

PA-free products must be 100% PA free

: The letter stated that such products should be completely free of PAs: "The agency believes that the presence of any measurable amount of these substances would cause the product to be adulterated under the Federal Food, Drug, and Cosmetic Act because we do not believe that there is adequate scientific evidence to establish an exposure level that would present no harm to consumers."

FDA also delivered a rationale for classifying any PA-free product as a "new dietary ingredient," as that term is defined by in regulations under the Dietary Supplement Health and Education Act (DSHEA). This rationale was based on the statement that "agricultural selection and, processing, to remove the pyrrolizidine alkaloids from comfrey described in your letter [would] render the comfrey to be 'chemically altered,'" and therefore a "new dietary ingredient." The letter also noted that FDA has not received any premarket notifications from members of industry regarding the intentions to sell such new ingredients (commonly known as a "75-day notice") and reminded AHPA that the marketing of a "new dietary ingredient" in the absence of a 75-day notice may subject a PA-free product to "be deemed to be adulterated per se under the Act."

AHPA is currently seeking information from any of its members who market PA-free products. They can contact Robin Gellman via email <RGellman@ahpa.org> if they can provide data on the length of time such products have been marketed, the analytical methods and level of detection for measurement of pyrrolizidine alkaloids in these products, and the company's intentions for continued marketing of such products. Gellman may also provide copies of the correspondence between AHPA and FDA on this matter.

[AHPA Update. American Herbal Products Assn. 2001 Nov 7.]

Congress Gives FDA More Money to Regulate Supplements

Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA) have been successful in obtaining a $1 million appropriations allocation added to an agriculture appropriations bill for additional FDA Center for Food Safety and Applied Nutrition enforcement, specifically for misbranded or mislabeled dietary supplements. It is expected that these funds will be used to enhance FDA's inspection and compliance programs regarding product quality, safety and labeling practices. In the same bill, an additional $3 million is provided to upgrade and modernize the adverse event reporting system for dietary supplements.

In a second amendment sponsored by the senators, a Labor and Health and Human Services bill was amended to provide $500,000 to cover legal activities associated with enforcing the product labeling provisions of DSHEA. Also, the bill provides $110 million to the National Center for Complementary and Alternative Medicine at the National Institutes of Health, some of which will be used to further develop the science of dietary supplements. This additional funding has been supported by all trade associations in the dietary supplement industry and will probably address one of FDA's long-standing obstacles to not taking appropriate and needed regulatory action against unsafe products and inappropriate claims.

[AHPA Update. American Herbal Products Assn. 2001 Nov 8.

Israelsen LD. Personal communication. 2001 Oct 26.]

Acknowledgements: The author thanks AHPA for the information provided in these releases. This article was based on and edited from releases from AHPA, plus additional information from other sources.