AHPA publishes heavy metals GMP guidance
The paper, “Heavy metal analysis and interim recommended limits for botanical dietary supplements”, builds on proposed interim limits for lead, mercury, cadmium and arsenic proposed by AHPA in October 2008.
The white paper, available as a free download to AHPA members, provides explanations as to how these limits were arrived at. Those that sign up to a webinar the Maryland-based group is also holding tomorrow on the issue, scheduled for 1pm, will also be able to download the paper also.
The webinar will delve into information contained within the white paper and address California’s controversial Proposition 65, certificates of analysis, liability concerns and additional contaminants including mycotoxins and pesticides.
The white paper outlines:
- regulations concerning lead, mercury, cadmium and arsenic in products sold in the US
- daily limits set for these chemicals by US and international regulatory agencies
- available analytical methods for measuring heavy metals
- how to determine which analytical methods are most suitable for dietary supplements
- selecting a contract lab that can properly conduct heavy metal testing
“AHPA’s goal is to help excellent companies of all sizes come into compliance with cGMP and continue producing superior, health-promoting products for consumers,” said McGuffin. “The webinar and white paper – produced with the guidance and assistance of members of AHPA’s Educational and Standards Committees, respectively – are practical tools to help meet this goal.”
Guidelines
The AHPA’s October interim guidelines set heavy metal limits as follows: Arsenic (10 µg/day)Cadmium (4.1)Lead (10)Methylmercury (2.0) It noted that the limits were only applicable to herbal supplements consumed at a total daily amount of five grams or less.
If this amount is exceeded, the dose should be established according to “current good manufacturing”. AHPA encouraged manufacturers and marketers to specify herbal ingredients that may require other limits of the above metals or to highlight products “that require reformulation or reductions in daily serving size in order to meet these limits.”
The guidelines also defined herbal extracts as those that resulted from “some processing of a raw agricultural commodity, often by using a solvent such as ethanol or water.”
Herbal extracts could be subjected to processes such as maceration, distillation or steeping, it said.
