Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the Advertising Standards Authority.
BREXIT - The CAP and BCAP Codes include many rules which seek to reflect significant pieces of EU law or UK law that has been made to implement EU law. As far as CAP is aware, the same rules and laws will apply on the day after exit as on the day before. This CAP News Article explains the position further.
Chitosan is often sold in tablet form as a “fat binder” and it is claimed that the product is effective at limiting fat absorption in the body. Marketers should tread carefully when promoting Chitosan, due to a lack of sufficient evidence to support such claims.
• Consider whether your product is a medical device or a food
• Don’t make efficacy claims
• Don’t underestimate the level of evidence required
• Beware of making safety claims
• Don’t encourage irresponsible use
While some marketers refer to fat binders as “supplements”, if the product is classed as a medical device, it won’t also be considered a food supplement for the purpose of the CAP Code.
If the product is classed as a medical device, marketers should ensure that they hold rigorous product specific scientific data, which proves that a medical device which acts as a fat binder can work as described (rule 12.1). See Weight control: Fat binders. Under The Medical Devices Regulations 2002, all medical devices must be appropriately certified and be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). See Healthcare: Medical devices.
If the product is not a medical device, it is likely to be considered a food supplement and therefore the Food rules (Section 15) will apply, in addition to any relevant Weight control and slimming rules (Section 13). Weight loss claims are considered to be health claims and are only permitted if they are authorised on the GB (NHC) Register. See Weight control: Food and Food supplements and Food: Health claims.
The ASA has ruled against ads promoting products containing Chitosan as “fat binders” and claims that Chitosan works in the human gut to limit the absorption of fat into the body (Direct Healthcare Ltd, 28 March 2012).
Despite the submission of a number of published articles and many documents in support of claims for efficacy, the ASA or CAP are yet to be convinced about the weight loss capabilities of Chitosan. As such, marketers should not make any efficacy claims whatsoever, unless they hold robust evidence consisting of product specific clinical trials on human subjects. See Substantiation for health, beauty and slimming claims.
Much of the evidence that the ASA has reviewed in relation to efficacy claims for Chitosan containing medical devices has included studies conducted on animals and on human subjects but has related to the management of hypercholesterolaemia, rather than to weight loss specifically (Rainbow Corporation Pte Ltd, 20 October 2010). Other evidence submitted has not been product specific or carried out on human subjects (Direct Healthcare Ltd, 28 March 2012) and as such, fell short of the level and type of evidence required.
The Code prohibits marketers from promoting any product as being safe or effective, merely because it is “natural” (rule 12.10). Claims such as "Since it is an entirely natural product, Xipisan causes no side effects, no chemical alteration of the bodys [sic] metabolism, no dangerous dehydration nor depression” and " ... diet pill with no side effects" have been ruled in breach of rule 12.9 (Famous Rainbow Corporation Pte Ltd, 20 October 2010).
Marketers must not encourage consumers to use a product irresponsibly, including using a product to excess (rule 12.9). The claim "If you want to lose weight normally, take one capsule before each meal. If you feel you are very overweight, take up to two capsules before each meal ... ", for a Chitosan containing product, was found to breach the Code in this way (Famous Rainbow Corporation Pte Ltd, 20 October 2010).
Marketers are advised to read Weight control: Fat binders and other entries on “Weight control".