The U.S Food and Drug Administration is readying a spoonful of GMPs for dietary supplement manufacturers. Most of the industry is willing-some are even anxious-to swallow that medicine. But the agency is also waving around a second dose, this one the equivalent of Castor Oil: a HACCP system. The FDA's final decision on factors such as sanitation of packaging and handling of labeling on the assembly line will be based on the extent to which it is swayed by any of the 80-plus comments it received as a result of its first draft of current good manufacturing practices (cGMPs) published in February. The comments come in more shades than Dennis Rodman's hair, everything from "make them tougher" to "can the cGMPs." The 1994 Dietary Supplement Health and Education Act (DSHEA) required the FDA to consider cGMPs explicitly for packaging of dietary supplements. The industry now must adhere to the cGMPs for the food industry. In November 1995, five dietary supplement trade associations submitted a suggested outline for cGMPs. The FDA proposal of February 7, 1997, is a regurgitation of that industry proposal. However, the FDA also asked for comments on whether those cGMPs ought to be supplemented in seven areas, including a Hazard Analysis and Critical Control Point (HACCP) system. Industry groups reacted with alarm to the possibility of FDA "add ons." Annette Dickinson, director of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), says, "Those seven questions indicate the FDA's thinking, which goes way beyond modeling dietary supplement GMPs on food GMPs, which is what DSHEA required." However, Dickinson notes that there does need to be GMPs. She refers to a recent FDA alert to suppliers and retailers of dietary supplements that list "plaintain" on their product labels. An FDA investigation of one product called "Chomper," sold by a company called Arise & Shine of Mount Shasta, CA, showed that there was digitalis lanata in the product instead of plaintain. Digitalis is a powerful heart stimulant. Arthur Whitmore, an FDA spokesman, says it is likely that the digitalis was foisted on Arise & Shine by an unscrupulous supplier who has not been tracked down. The FDA has asked companies selling supplements with plaintain to analyze those products for evidence of digitalis. "Our GMPs require everyone in the supply chain to do at least one laboratory test on every ingredient to assure its identity," explains Dickinson. She says the digitalis problem would never have occurred if cGMPs were in force. Citing safety record This plaintain situation notwithstanding, some companies oppose any GMPs. They argue that the industry's excellent safety record, especially when compared to other foods and drugs, makes any specific cGMPs unnecessary. The leading proponents of the "leave us alone because we are safe" view are small manufacturers such as Pure Encapsulations, Inc., Trace Minerals Research and American Nutrition Corp. Not only do they argue that cGMPs are unnecessary, they also complain those FDA-imposed measures would put them out of business. Pure Encapsulations estimated it would have to eliminate up to 35% of its product offerings leading to a loss of $1.5 million to $5 million in sales per year. Consumer prices would increase between 30 and 200%, depending on the current price per bottle. Pure et al. argue that GMPs will be no sweat for big companies. Patrick Dunn, vice president of technical affairs for Leiner Health Products, Carson, CA, says that situation is also true for his company, which adheres to drug GMPs. Those GMPs are stricter than those for food. So, for example, Leiner does reconciliation of labels, which is not required under the food GMPs. Tamper-resistant packaging is used for all products, even though it, too, is not required. One section of the suggested cGMPs proposed by the FDA last February discusses requirements on packaging and labeling operations. Is cleaning and sanitizing enough? Basically, supplements would have to be packaged in a way that prevents adulteration. Compliance could be proven in a number of ways, including adequate cleaning and sanitizing of all filling and packaging equipment, using "safe and suitable" product containers, and using sanitary handling procedures. Packages would have to be inspected before they left the plant to make sure the labels were correct. Kimberly Austin, an official with the National Restaurant Assn., thinks that the FDA's proposed method of sanitizing packaging is insufficient, since the standard is lower than it is for foods. Dietary supplement manufacturers would have to "adequately treat equipment, containers, or utensils by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms." The Food Code has a higher standard. It requires a manufacturer to "apply cumulative heat or chemicals on cleaned food contact surfaces that when evaluated for efficacy, yield a reduction of five logs, which is equal to 99.999% reduction, of representative disease microorganisms of public health significance." But questions about the adequacy of packaging sanitation will pale beside those on the necessity of HACCPs, which would be in addition to the cGMPs, not in place of them, notes the FDA's Robert Moore, who is handling the rulemaking. The industry reaction to the possibility of a HACCP program was a resounding "no thanks." Typical were the comments of the National Nutritional Foods Assn., a Newport Beach, CA-based group. It said, "NNFA opposes adoption of a Hazard Analysis Critical Control Points system for dietary supplements. While a HACCP system is flexible, food industry experience with HACCP is very limited, and it has never been utilized in the dietary supplement industry." Moreover, unlike cGMPs, HACCP lacks particular standards designed to assess identity, strength and quality on an ingredient-by-ingredient and a product-by-product basis." c
