GMPs will weed out unscrupulous companies, say insiders
affect the profits of unprepared supplement makers, but industry
insiders say the costs are justified by the need to make sure all
companies adhere to standards, reports Jess Halliday.
According to David Barnes, vice president, technical affairs and manufacturing operations at Reliv International, companies which do not adopt manufacturing practices more aligned with pharmaceutical companies may find they have to make price increases to meet the costs of compliance.
Barnes told NutraIngredients-USA.com: "It's going to be an eye-opener for other companies that operate as food manufacturers."
Reliv recently announced its membership of the Council for Responsible Nutrition (CRN) and wants to be seen as a leader in the supplements industry, helping to shape it instead of riding on the coat tails of its competitors.
In March the company invested more than a million dollars in increasing throughput and building higher quality standards at its St Louis manufacturing facility, a move that Barnes called "one of the best things we have ever done in the company".
The facility fulfills demand for Reliv's supplements from its operations all over the world and since 1993 has been audited by the Therapeutic Goods Administration of Australia, where supplements are subject to the same standards as pharmaceuticals.
However the CRN says that the vast majority of its members already have manufacturing practices that are as good or better than the FDA will require. The challenge, the council's VP for scientific and international affairs, John Hathcock, told NutraIngredients-USA.com, will be in reporting these practices.
He said that the FDA has "massively misjudged the economic cost for a company going through the process, especially in record-keeping". It estimates that a company will need to spend around $47,000 on compliance, depending on its size.
Nonetheless, Hathcock sees the cost as entirely necessary. "If you can't afford to make good products, you shouldn't be making products at all," he said, adding that one company that fails to comply gives the entire industry a bad name.
The cGMPs form part of the 1994 Dietary Supplement Health and Education Act (DSHEA). The CRN believes that DSHEA will be sufficient in ensuring the safety and quality of supplements if properly enforced, said Hathcock, but that has not yet happened.
The CRN maintains that the current draft, published 18 months ago, places too much emphasis on testing - which verifies quality but does not impact standards at source - and not enough on safety.
As for when the cGMPs will come into effect, no date has yet been announced. Hathcock has said he anticipates that the permanent appointment of Lester Crawford as commissioner of the FSA, announced by the agency yesterday, will expedite publication.
The CRN currently has a membership of 80 ingredients suppliers and manufacturers, which adhere to a strict code of ethics, comply with dosage limits and manufacture supplements to high quality standards.
The council promotes self-regulation among its members, and, since its foundation in 1973, has played a role in shaping dietary supplement legisliation and challenging the FDA over what it calls "over-reaching efforts to restrict dietary supplement sales".
