Q: How is IDDI™ Verification different than GMP Audits?
A: IDDI™ Verification complements and supports GMP audits. GMP certification audits are very important, and include more than 200 different checks – a few of which relate to whether identity testing was performed. However, the scope of GMP audits often does not include an analysis of whether identity test method and results were scientifically valid (the FDA requirement), which can require specific expertise on the identification of individual ingredients.
Q: How do I get started?
IDDI™ Verification can be completed in six simple steps listed on the Get Started page.
Q: What are the rates for IDDI™ Verified?
A: IDDI™ Verified is priced on a per-project basis with a typical base price of $375 per ingredient.
Contact us for more information on pricing of IDDI™ Verification for multiple ingredients, education and training support.
Q: How long will it take to receive IDDI™ Verification?
A: The time required to become IDDI™ Verified varies depending on the quality and quantity of the information provided, and the amount of followup required, but some IDDI™ Verified reviews can be performed within ten business days.
Q: What are acceptable test methods for the ID of different types of ingredients?
A: The following are analytical principles that are typically acceptable for certain kinds of materials. Often, two or more tests are required in order to confirm the identity of a material. For example, it is well established that organolepsis can be a supporting test for botanical plant materials, but its results cannot stand alone.
Pure compounds: HPLC, TLC, IR Spectroscopy, NMR and others
Botanical plant materials: TLC, Macroscopy, Microscopy and others
Botanical powders: Microscopy, TLC, HPLC, GC and others
Botanical extracts: TLC, HPLC, GC and others
Others: Depends on the nature of the ingredients
No matter how expensive the test or instrument, the scientific validity of identity results require test method suitability and authenticated reference standards.
Q: Is DNA testing suitable for determining identity of a dietary ingredient?
DNA has a place in identity testing, however its usefulness and validity can be limited. For example, DNA is generally not stable or soluble in extraction of botanicals, so DNA will not be found in many botanical extracts. Further, no organism contains just one type of DNA: Humans contain the DNA of micro-organisms, and plants do too. Plants which grow in soil are not enclosed in a bubble, so they cannot avoid having some trace levels of various DNA from insects and neighboring plants. In fact, a certain percent of foreign materials (such as weeds, insects and organic matter) is generally listed on the specification of most raw botanical materials! So, while DNA can be used to confirm the identity of the primary constituent of a natural dietary ingredient, it requires some specific expertise to interpret correctly because it is subject to naturally occurring interferences.
Q: Does IDDI™ perform any actual testing?
A: If test reports or documentation does not satisfy the requirements, IDDI will recommend specific testing at pre-approved laboratories, whose passing report will be required in order to receive IDDI™ Verified status. IDDI™ can arrange testing of samples at pre-approved laboratories for an additional fee.
Q: Can consumer products with multiple ingredients be certified?
A: Scientifically valid identification methods generally focus on single ingredients, due to the challenges associated with identifying mixtures of multiple ingredients as are found in consumer products. The typical scope of IDDI is to certify ingredients of a single botanical origin or pure chemical compounds. However, a product or ingredients containing multiple ingredients may be able to be IDDI™ Verified. Materials containing multiple active ingredients may be submitted for pre-qualification which will determine if IDDI™ Verification is likely or unlikely to be performed.
Consumer products containing multiple ingredients may become IDDI™ Verified if either of the following requirements are met:
1) Specification, test method and test results supporting the identity of each ingredient before being combined into the product can be supplied, along with a specification from the finished product manufacturer and batch record listing all ingredients; OR
2) The identity of all ingredients in the finished product can be tested and shown with ID testing results.
Q: Is identification of excipients in products such as maltodextrin required?
A: Excipients and other processing aids used in manufacturing such as solvents, enzymes and flow agents must be listed on the ingredient specification, although they do not typically require an identification test. In the case of consumer products, the product label must list all inactive ingredients in the same order of descending concentration listed on the specification.
Q: How do I know whether there are suspected adulterants for my product?
The following resources are available:
- IDDI Expert Staff and Expert Panel
- Approved laboratories and trade associations listed as follows:
- www.theplantlist.org which lists common synonyms or substitutes for botanicals
- The Essential Guide to Herbal Safety (Mills and Bone, authors). Available on Amazon.
Q: What are some accepted forms of proof supporting lack of adulteration?
Adulteration of products can be difficult to detect, and there is no one-size fits all litmus test. Here are some common
- Physical or biological analysis for markers indicating presence of the adulterant, such as microscopy.
- Chemical analysis for markers indicating presence of the adulterant
- Thorough manufacturing records, including batch manufacturing records (BMR), product specifications, and signed statements on manufacturer’s letterhead may be required if test results are determined to be inadequate, and the ingredient is considered “high risk” for possible adulteration.
Q: Have additional questions? Contact us!