U.K. Herbal Guidance Frowns On Efficacy Claims, Study Citations

The U.K.'s first guidance on herbal remedy advertising regulation compliance emphasizes clarifying the products are not proven effective.

The U.K. Medicines and Healthcare products Regulatory Agency, which published the ¹ guidance Nov. 27, said that unlike OTC drug firms, "many of the companies registering products under the [traditional herbal medicines] scheme have not previously had practical experience" with regulations on advertising.

The guidance elaborates on MHRA's 2005 registration scheme for manufactured OTC herbal remedies. It also follows the agency's development of a symbol that firms can add to packaging to indicate a product meets U.K. standards (² (Also see "U.K. Regulators Crack Down On Unlicensed Herbals, Promote Standard" - Pink Sheet, 17 Mar, 2008.)).

Under U.K. regulations, herbal medicinal products can be indicated for "minor, self-limiting conditions," an MHRA official said in an e-mail.

Herbal product advertising regulations differ from regs for other medicinal products by "one additional requirement," according to the guidance. Ads must "include a specified form of wording to inform the consumer that the efficacy of the product for the stated indications is not scientifically supported."

Ads for herbals must carry the disclaimer: "Traditional herbal medicinal products for use in [one or more indications] exclusively based on long-standing use as a traditional remedy."

The Proprietary Association of Great Britain says the "traditional remedy" language is the key element of the guidance.

The guidance should help firms stay out of trouble by reducing "the potential for misinterpretation, which could lead to upheld complaints about advertisements and regulatory sanctions," the OTC drug and nutritional product trade group said in an e-mail.

MHRA says firms must place the disclaimer "clearly in the body of the advertisement rather than as a footnote" to comply.

This requirement differs from dietary supplement regulations in the U.S. Herbal and nutritional products often carry in fine print the required language that claims for the products are not approved by FDA.

Based on a review of member companies' ads, PAGB says the most common advertising error is omitting the mandatory disclaimer. Other common mistakes are not including a product's active ingredient and making efficacy claims such as "relieves" rather than "traditionally used to relieve."

Study Citations Present "Obvious Risk"

Firms should not reference clinical studies in herbal product ads due to the "obvious risk of exaggerating the benefits of the product," the guidance says. Advertisements that mention clinical studies also must clarify "there were insufficient clinical data to demonstrate the efficacy of the product," according to the guidance.

MHRA also advises against the use of testimonials in herbal product ads. "It would be very difficult to include testimonials that make personal efficacy claims ... in brief advertisements because of the potential to mislead."

However, the guidance says online ads generally would have sufficient space to include testimonials along with language that makes it clear those references represent individual opinions and do not imply proven efficacy.

MHRA is doubtful, though, that the same allowance could be made for clinical study references on Web sites or in other longer advertising formats. The agency says "the practicalities of this would need careful consideration."

While traditional herbal medicines do not require marketing authorizations from MHRA, the products must be registered with the agency. All herbals registered so far with MHRA are available through general sale, or OTC.

Records show MHRA regularly receives complaints about herbal product ads.

An August complaint alleged claims about herbal medicines advertised on the "coughs and cold page" of the Potters Limited Web site were not backed by scientific evidence, and a January complaint said ads for Duchy Herbals' Echina-Relief Tincture and Hyperi-Lift Tincture suggested the products were assessed for efficacy. The agency upheld both complaints and the firms agreed to comply.

- Malcolm Spicer ( ³ [email protected] )