Harmonization Eyed For EU Botanical Claim Regs, With Tighter Scrutiny

Two options are touted for botanical claims legislation in the EU – one would continue with the existing process under the European Food Safety Authority’s evaluation of claims for all types of supplement products and the other would align botanical regs with the medicines sector.

Health regulators and the consumer health care products industry are considering two options for regulating botanical supplements marketed in the European Union, including one that would improve harmonization of EU member states’ policies on health claims but also increase regulatory scrutiny of product claims.

The debate by the European Commission, EU members and manufacturers on whether to reform EU health claims regulations for botanicals comes as the Dec. 14 deadline approaches for all types of supplement products with claims already on the market to receive European Food Safety Authority approval (Also see "European Nutrition Groups Challenge EFSA Health Claims Policy" - Pink Sheet, 20 Aug, 2012.).

EFSA’s rejection of the majority of claims submitted led to the European Court of Justice considering multiple challenges and stoked industry’s desire to settle the issue and provide clarity on regulatory oversight of herbal product claims.

The two routes forward in botanical claims regulation that now appear acceptable were discussed at an Association of the European Self-Medication Industry conference on herbal medicines legislation in Brussels, Belgium, Nov. 7-8.

The first option would maintain the status quo, continuing to apply the current health claims regulation, with EFSA either approving substantiated claims or rejecting those the agency finds unsubstantiated.

However, this process is fraught with problems. One is that member states have different views on health claims for botanicals, which in some cases put them at odds with EFSA.

Another problem is nutritional product manufacturers and industry trade groups are asking a court to shut down the agency’s supplement claims regulation, including striking the deadline for existing products to receive claim approvals or be pulled from the market. Rulings were not made in those cases as of Dec. 6.

Harmonization At A Price

The second option, which proponents say would increase harmonization across the EU, would establish a legal framework in the food sector for botanicals as a subset of herbals. The idea behind this proposal is that claims made for botanicals could be upheld under the “traditional use” heading detailed in EFSA’s Traditional Herbal Medicines Directive that came into full force in April 2011 but does not currently cover the food area (Also see "EU Herbal Medicinal Directive Could Spike Supplement Firms’ Costs" - Pink Sheet, 13 Apr, 2009.).

Should the EC go for the second option, industry would begin a difficult legislative process. New food sector regulations for botanicals adopted under this option would operate in parallel with existing medicines sector regs, which AESGP Director General Hubertus Cranz says would be costly for manufacturers.

The danger is that aligning food sector regulations with the medicines sector – pertaining in particular to food supplements – could render the herbal medicines space less attractive for manufacturers interested in comparatively swift and easy entry to the market.

Companies can avoid the more complex and expensive herbal medicines authorization process by opting to seek marketing approval through food sector legislation. But aligning food sector regs with medicinal product rules would take away that option.

"In business terms it would of course have considerable implications," Cranz said.

Not only would manufacturers pay for authorization and registration, but there also are follow-up costs for pharmacovigilance, maintenance of the marketing authorization and potential variations to it. Further, additional good manufacturing practice rules are in play under medicine sector rules.

"The cost element is an important factor because the medicines legislation on the whole is rather expensive," Cranz said.

He pointed out that the robust medicines sector system has not complained that food sector legislation by any means lacks potency. "But in general the differences are widely recognized," he said.

Members Lean Toward Status Quo

A majority of member states are leaning toward keeping the status quo, although they would not discount the other option altogether.

“Option two is attractive in that authorities in the member states are often uncertain and don’t know what to do in some cases,” Cranz said.

The debate also is colored by a perhaps more difficult problem for industry. If claims need to be substantiated, supplements could be on the same regulatory path as medicines with warnings required in some labeling, a costly obligation for manufacturers.

“Currently we say that food, in principle, is safe,” Cranz noted.

The addition of health claims also would bring with it the need for quality assurance, especially for food supplements, since the issue of stability testing would need to be addressed as the plants in question contain active ingredients.

Moreover, because botanicals would only be permitted a health claim, a debate would be needed on distinguishing those claims from medical claims, a list that Cranz says is endless.

“This makes the whole issue of a systematic harmonized approach to herbals in food and in particular in food supplements a very difficult one,” he said.

Manufacturers are unlikely to learn soon which path the legislation will take. The EC’s decision will wait until a new health commissioner is appointed and the commission receives that official’s input. However, the next health commissioner will have other priorities, including revisions to clinical trial rules, cross-border health threats and pending medical devices legislation.

Tonio Borg, a former health minister from Malta, received the European parliament’s approval for the post in November and his final review – by the EU Council of Ministers – is expected this month (Also see "EU Health Commissioner Candidate Remains Question Mark For Pharma" - Pink Sheet, 26 Nov, 2012.).