DIETARY SUPPLEMENT LABELING STANDARDS PROPOSED IN VOLUNTARY GUIDELINES

DIETARY SUPPLEMENT LABELING STANDARDS PROPOSED IN VOLUNTARY GUIDELINES for general quality assurance and safety that were drafted by the Natural Products Quality Assurance Alliance. NPQAA, which presented the draft industry guidelines at the National Nutritional Foods Association's annual meeting in Las Vegas July 16-19, is devising separate quality assurance and safety standards documents specifically for homeopathic products, edible oils, garlic supplements and herbal products in addition to dietary supplements in general. An independent alliance, NPQAA was founded by HealthComm President Jeffrey Bland, PhD, in September 1991 to encourage the dietary supplements industry to assume "a proactive position" on quality assurance and product safety in response to the epidemic of eosinophilia myalgia syndrome associated with consumption of L- tryptophan supplements. NPQAA is funded by contributions from industry participants including NNFA. The draft guidelines, which Bland said represent the first industry-wide attempt at self-regulation, recommend that dietary supplement labeling should always feature a shelf-life date. The date would appear in a "best before" notice if the product "cannot maintain labeled amount claims and physical characteristics for three years from [the] date of manufacture," the draft guidelines state. However, dating would be applicable only to "nutrients for which a [Recommended Dietary Allowance] is established (excluding minerals and mineral supplements) [and] nutritional supplements for which a specific potency claim is made." The draft also suggests that manufacturers display the lot number of the product and maintain "permanent records" on product batches to ensure adherence to good manufacturing practices regulations. The draft guidelines add that product labeling should emphasize that "the product is a dietary supplement as opposed to a conventional food" and explain "appropriate cautions, contraindications or limitations for use." The guidelines underscore that shelf talkers, point-of- purchase displays, newsletters, advertisements, bags and boxes, cards and tags, flyers, product brochures, magazine articles, posters, banners, signs and product packages all should be considered labeling, and should comply with the alliance's code of legality and integrity. Dietary supplement manufacturing procedures outlined in the NPQAA draft are based largely on manufacturing guidelines released by the U.S. Pharmacopeia in March. The NPQAA draft guidelines advise that companies retain batch and laboratory control records "for at least one year after the shelf-life date of the batch." Companies are also directed to establish "complaint files," which should be reviewed by the company's quality control unit to determine "the possible failure of a product to meet any of its labeled claims and . . . the need for an investigation," according to the NPQAA draft. Calling the guidelines "a forum [and] not a formula" in an introduction to the draft guidance, NPQAA maintained that "it should be readily apparent" that "the [dietary supplements] industry has worked arduously to develop standards of quality and safety for its products." NPQAA added that the guidances "might eliminate the necessity for [federal] rulemaking by demonstrating 'self-regulation.'" Bland told a July 16 NNFA session that "we are really moving towards discussion which has been the sacred cow of this industry for some years" -- self-regulation. "No one wants to step up to the bat and deal with that sticky issue," he said. However, Bland urged the NNFA audience to "put aside petty differences and move towards a unanimous discussion of commonality concerning safety claims and accuracy of information on products." The dietary supplement draft guidelines were developed based on suggestions culled from approximately 300 individuals representing 100 organizations including dietary supplement manufacturers, suppliers and retailers. The draft guidances are currently being circulated to the industry for editing and additional input. Finalized guidelines are expected to appear in an "NPQAA Standards and Practices" book slated for release in the first half of 1994. NPQAA stressed, however, that the final guideline would remain "a living and growing document." Draft guidelines for product categories other than general dietary supplements are further behind in the development process. The other guidances are being devised based on the input of two herbal products manufacturers, three garlic supplement manufacturers and six edible oil product manufacturers. Guidelines for homeopathic products are expected to be based on standards set by the Homeopathic Pharmacopeia of the U.S. as well as on FDA GMPs, according to NPQAA. Voluntary compliance guidelines have already been issued by other supplement industry groups including NNFA, the Council for Responsible Nutrition and the American Herbal Products Association. However, those guidances were for members of those associations only and were not intended for use by the entire industry. NPQAA noted that NNFA, CRN and AHPA all were consulted prior to the drafting of its guidelines. Separately, NNFA members voted at the association's July 18 annual business meeting to make future NNFA membership dependent on enrollment in the recently finalized "Tru-Label" program. The program, which requires that companies verify the "integrity" of ingredients contained in their products, is enforced by NNFA's Committee for Product and Label Integrity.