Nutritional supplement regulations worry European industry

A tale of two continents

04 November 2009 00:00  [Source: ICB]

New regulations have pleased US manufacturers of nutritional supplements, but in Europe, the industry fears authorities are overreaching themselves

Rex Features

Cynthia Challener/Vermont

IN THE US, manufacturers of nutritional supplements have welcomed the latest good manufacturing practice (GMP) regulations and increased Food and Drug Administration (FDA) enforcement as developments that will eliminate fringe manufacturers and improve the industry's overall image.

In Europe, however, manufacturers are concerned that many of the 4,000 or so health claims being made for supplements may be rejected by the European Food Safety Authority (EFSA), because of its requirements for supporting scientific data.

GMP regulations for the manufacture of nutritional supplements went into effect in the US in June 2008. All companies with 500 or more employees have since been inspected by the FDA, with no major issues identified, according to Daniel Fabricant, vice president of scientific and regulatory affairs for the Natural Products Association (NPA), a US-based group representing more than 10,000 retailers, manufacturers, wholesalers and distributors. The inspection of medium-sized companies is likely to begin later this autumn, while small companies (under 25 employees) are required to be in compliance by June 2010.

"The overwhelmingly positive results of the first round of GMP inspections confirm what the industry has known all along - that dietary supplement producers take the necessary steps to ensure that their products are safe," Fabricant asserts.

Adverse event reporting is another new requirement for the industry. "Since this regulation was implemented in 2007, reports of adverse events from dietary supplement use have been minimal, particularly when compared to the pharmaceutical industry," states Fabricant. "Not surprising to us, the data again confirms that dietary supplements are safe and that manufacturers are responsible."

According to the Council for Responsible Nutrition (CRN), a US-based trade association representing dietary supplement manufacturers and ingredient suppliers, the FDA received only 1,080 total adverse event reports in 2008, 672 of which were considered serious. In the same period, the FDA received 526,000 adverse event reports related to drugs and biologic products, more than 300,000 of which were considered serious.

ILLEGAL PROMOTION
There are companies that don't comply with this regulation, or any others, for that matter, but these "fringe" companies account for only a small percentage of all products sold in the US, says Andrew Shao, CRN's vice president of scientific and regulatory affairs.

Both the NPA and CRN say they support recent efforts by the FDA to track down companies pursuing criminal activities.

In 2009, for example, the agency issued public health advisories about body-building products containing steroids and steroid-like products, and more than 70 weight-loss products. In all cases, it found the products to contain unapproved or misbranded drugs.

Since issuing its first consumer alert regarding weight-loss products in December 2008, the FDA has expanded its list of "tainted" products, some of which are supplements that contain undeclared active pharmaceutical ingredients (APIs). Several of the manufacturers have been inspected and the agency is seeking product recalls. Additional enforcement steps may be taken as well.

Shao says he would actually like to see more enforcement from both the FDA and the Federal Trade Commission (FTC).

The FTC has also taken actions against marketers of dietary supplements. In late 2008 and in 2009, several US firms were charged with deceptive advertising of supposed weight-loss products containing hoodia, and for making false claims that dietary supplements and related medical devices treated or prevented a number of diseases.

The pharmaceutical industry - with which supplement makers contrast themselves as the "natural" alternative - is not satisfied, however. In April 2008, UK-based GlaxoSmithKline and other drug companies filed a petition requesting that, because obesity and excess weight are significant risk factors for certain diseases, all weight-loss products should be treated as drugs.

"It is unlikely the agency will accept the petition, as to do so would signal a significant change in the FDA's approach to health claims in general," says Vincent Annunziata, a consultant at NutriCompliance, a US-based consultancy serving the nutritional supplements industry.

In late 2008 and early 2009, the FDA issued guidance documents addressing substantiation guidelines and explaining its process for reviewing scientific evidence. In general, there were no surprises in the documents, but many in the nutrition community take issue with the FDA's overall approach.

"The system is based on the pharmaceutical industry, and is an overly simplistic one when applied to dietary supplements," says Shao. "The agency is relying heavily on clinical data, which is hard to generate for supplements, which, by definition, are designed to maintain health and prevent chronic disease."

EUROPEAN DISCORD
Scientific substantiation of claims is also at the heart of a real controversy for the dietary supplement industry in Europe.

"The situation is very complex and difficult," notes Patrick Coppens, secretary general of the European Responsible Nutrition Alliance (ERNA).

The EU nutrition and health claims legislation was passed in 2006, but the European Food Safety Authority (EFSA) only began handing down decisions in 2009.

"The standards for scientific substantiation are very high, and there are concerns that existing claims for food and food supplements will be found not to have proper scientific justification," Coppens explains.

Of the initial evaluations completed, nearly 80% were not approved. The EFSA planned to review nearly 1,500 claims by the end of November 2009, but it has already sent back about 2,700 for further clarification. As a result, the agency will not be able to meet the January 2010 deadline for completion, and an extension will be necessary.

Many supplement manufacturers have indicated there is great confusion over what exactly is needed in the way of scientific data to support claims. They are not sure what evidence is required and how much is enough.

"It is definitely a quagmire," says Fabricant. "A lot of clarity is still needed."

In addition to this critical issue, there are other initiatives underway in Europe, including harmonization of usage-level recommendations for vitamins and minerals. A proposal containing recommended maximum levels is expected in the near future, but disparity is rife among member states, and a final consensus is likely to be difficult.

The EFSA has also issued a proposed guidance on assessing the safety of food supplements containing botanicals. Currently, the guidance document is voluntary, and the legal implications are unknown.

There is concern that the agency relied on theoretical evaluations without considering industrial purification and other processes that eliminate many of the risks highlighted by the document. Results from the testing of several botanicals are to be presented later this year.

"[European legislation] is definitely a quagmire. A lot of clarity is still needed

Daniel Fabricant, vice president of scientific and regulatory affairs, Natural Products Association

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