US nutritional supplements industry regulations come into force

Good enough to eat

23 April 2008 17:03  [Source: ICB]

Tough new manufacturing guidelines from the US Food and Drug Administration aim to raise quality standards in the nutritional supplements market

Cynthia Challener/Vermont

US DIETARY supplement manufacturers will finally be required to adhere to current Good Manufacturing Practices (cGMPs) this summer. It is a year since the US Food and Drug Administration (FDA) issued its final rule on the subject and 14 years since the US Dietary Supplement Health and Education Act of 1994 (DSHEA) first authorized the cGMPs.

The dietary supplement industry, which has been in favor of cGMPs, hopes they will increase consumer ­confidence in the quality and safety of dietary supplements.

The new rule, which will be phased in from June 22, is intended to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination, and improper packaging and labeling.

In 2006, for example, the FDA discovered several dietary supplement products containing undeclared active pharmaceutical ingredients used in prescription drugs for erectile dysfunction. And in 2005, the agency issued a warning letter to a firm producing products that contained significantly less vitamin A, vitamin C and folic acid than claimed on the label. In 2004, another firm received a warning letter for underweight tablets.

Although such issues reflect a clear ­parallel with pharmaceutical production, dietary supplements are regulated like foods under the DSHEA. They are, however, unique in the food category, bridging the gap between foods and pharmaceuticals. Under the DSHEA, Congress gave the FDA authority to issue regulations establishing cGMPs specifically for dietary supplements. In June 2007, they were issued in a final rule.

"The dietary supplement cGMPs should increase consumers' confidence in the quality of the dietary supplement products that they purchase," comments Robert Brackett, director of the FDA's Center for Food Safety and Applied Nutrition. "These regulations provide more accountability in the manufacturing process so that consumers can be confident that the products they purchase contain what is on the label."

QUALITY EVALUATION

The rule applies to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved in testing, quality control, packaging and labeling, as well as US distribution.

Manufacturers will be required to evaluate the identity, purity, strength, and composition of their dietary supplements.

If dietary supplements contain contaminants, or do not contain the ingredient they claim to contain, the FDA would consider them adulterated or misbranded. The consequences could range from a request that the manufacturer remove an ingredient or revise its label, to product seizure, a lawsuit or criminal charges.

The regulations will establish controls throughout the manufacturing process. There are requirements for establishing quality control procedures, designing and constructing manufacturing plants, proper manufacturing operations, maintenance and cleaning procedures, and testing of ingredients, finished products and in-­process materials, besides provisions for ­handling consumer product complaints and record keeping.

Central to success is the need for manufacturers to establish specifications and then implement methods ensuring they are met, says Michael McGuffin, president of the American Herbal Products Association (AHPA). "We are stressing to our members that when setting these specifications, they be certain they can meet them and that they have a method for proving that they do," he comments.

The Natural Products Association (NPA) established its own GMP certification program for dietary supplements in 1999, when it became obvious that FDA ­regulations would be some time in ­coming. The NPA's program is based upon third-party inspections of manufacturing facilities to determine compliance with standards that are similar to those in the final regulation.

NPA vice president of scientific and ­regulatory affairs Daniel Fabricant believes the GMP rule is tough, but fair. He particularly appreciates the regulation's attention to the in-process aspects of manufacturing dietary supplements.

"The process control requirements help companies ensure they are producing what they say they are producing, and serves as a mechanism for piecing together control of raw ingredients with final product testing," says Fabricant.

Jim Lassiter, director of technical affairs at US manufacturer Robinson Pharma, points to the documentation requirement, which greatly exceeds industry general practice. However, the regulations will only have an impact if the FDA enforces them, he points out.

"Based on announced budgetary commitments, it appears the FDA is taking its responsibility quite seriously," adds Kenn Israel, the company's vice president of marketing.

McGuffin, however, does see some shortcomings. He would like to see a definition for the terms "manufacture," "package," "label" and "hold," since these actions are what trigger coverage by the rule, and interpretations can differ. Lot numbers should also be required on the package to facilitate tracking in the case of a recall, he says.

Lastly, as written, ingredient suppliers with materials that are repackaged by a manufacturing customer will be required to comply. "It does not seem appropriate to have a company covered by a regulation based on what actions its customers take," McGuffin asserts.

RAISING THE LEVEL

Dietary supplement manufacturers will be required to do some sort of test for ingredient identity before they can qualify a supplier, notes Joel Rothman, an attorney with the Florida-based law firm of Seiden, Alder, Matthewman & Bloch and a consultant with NutriCompliance, a regulatory consultancy serving the nutritional supplement industry. "Previously, companies would rely on a supplier's certificate of analysis [CoA] to confirm an ingredient's identity," he says.

The qualification requirement will certainly have a definite impact on the industry, says Rothman. "Because current GMPs impose responsibility upon supplement marketers for the purity, quality, strength, and composition of the ingredients that go into their products, companies that purchase ingredients must be vigilant and verify all of these materials, especially those imported from China."

The FDA is aware that the majority of dietary ingredient manufacturers are offshore, where there is no realistic way for them to assert their inspection and audit authority, says Vincent Annunziata, also a consultant for NutriCompliance. "Therefore, the agency has placed the burden of assuring ingredient identity on the dietary supplement manufacturer or marketer."

According to Israel, there are over 1,000 different ingredients used in dietary supplements, and most are not fully characterized, nor are there universally accepted analytical methods for them.

"We, as manufacturers, understand the need to properly characterize these materials," he adds. "With the new GMP regulations, we will be creating ever-more detailed specifications and effective analytical methods, thereby pushing ingredient suppliers to provide the highest-quality materials possible."

If companies have been making ­buying decisions based on reasons other than ­quality and good documentation, they will have to find new suppliers, Fabricant adds.

The regulation is to be phased in according to company size. Companies with more than 500 employees must be in compliance by June 22, 2008. Those with fewer than 500 but more than 20 employees have until June 2009. The smallest companies have until June 2010.

The few large companies in the industry generally have good quality procedures in place and often have established processes based on existing food or pharmaceutical cGMP regulations, so the transition for them, according to Rothman, will be relatively trouble-free. "Likewise," he adds, "low-quality manufacturers unable or unwilling to meet the significant increase in the level of documentation and testing will be operating on borrowed time."

The economics of compliance are not so onerous that they will drive small firms out of business," says Lassiter.

"But some smaller tablet/capsule facilities with non-compliant practices will likely have to make a choice to change their business model, merge with a larger firm or leave the market."

According to Israel, medium-sized firm Robinson Pharma is already in compliance through its participation in various GMP programs with third-party certification that is using the new rules as a foundation for verification of compliance. "Most companies are addressing the requirements in a stepwise fashion," McGuffin observes.

After evaluating existing procedures and systems and identifying gaps, they will work on addressing those areas. Many meet some of the requirements but may need to formalize systems or make slight modifications.

"Companies that are committed to the industry will find a way to remain competitive and be in compliance," he adds.

US SALES OF DIETARY SUPPLEMENTS

	2005 sales	2006 sales	2006 growth rate
Supplements overall	$21.3bn	$22.5bn	5.4%
Vitamins	$7.2bn	$7.5bn	4.9%
Herbs	$4.4bn	$4.6bn	4.1%
Meal Supplements	$2.3bn	$2.4bn	2.7%
Specialty/other	$3.4bn	$3.8bn	11%
Sports nutrition	$2.2bn	$2.4bn	6.2%
Minerals	$1.8bn	$1.8bn	2.1%

Source: Nutrition Business Journal

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