to ask suppliers about their products
following questionnaire takes a comprehensive look at all areas
that affect quality in the process of manufacturing dietary supplements.
By asking manufacturers any of these questions, you will be contributing
to enhanced quality in the dietary supplements that you consume.
What are the sources of your ingredients?
Do you grow your own ingredients exclusively?
Buy directly from growers or producers, buy from wholesalers,
or a combination of sources?
What criteria do you use in selecting your sources?
How do you ensure that ingredients are free of impurities and contaminants?
How do you determine their level of potency?
you test ingredients in an in-house lab?
Obtain certifying documents from growers/producers?
What steps do you take to evaluate the accuracy of supplier's
If ingredients are organically grown or "wildcrafted," how do you
assess source areas in terms of natural state and freedom from toxic
Are your ingredients synthetic or natural in origin? How do you
differentiate between the two?
Do you require statements of non-irradiation from botanical suppliers?
If you produce vegan products, please describe the manufacturing
process for gelcaps.
Please describe the composition of the filler powders and/or extract
solutions used to produce your products.
Certain substances, such as corn, milk, and soy, can cause allergic
reactions in certain individuals. When such substances are used
in your products or formulations, how do you highlight their presence?
Describe the methods and procedures you use for storing raw ingredients
before processing and how you store final products before shipping.
HVAC controls such as air conditioning
Composition of storage containers
Storage time limits (shelf life) in warehouse/at distributor,
Describe the general nature and methods of your manufacturing process.
If you are a larger organization, please include the following information:
What types of machinery do you use?
Do you run single or multiple production lines? Work cell or straight
line? Please describe.
To what extent are your operations automated? Alternatively, do
you engage in "craft" manufacturing rather than continuous operations?
Do you employ degreed industrial, chemical or pharmaceutical production
Have you implemented an enterprise resource planning or supply
chain management system?
Describe the nature and scope of your cleaning programs.
Duration of machine/device/line use between cleanings
Types and strengths of cleaning substances used
Precautions and tests used to ensure products are free of cleaning
Do you use a lot-tracking system that can identify all the ingredient
sources of a particular bottle? If this system is implemented in
software, please provide name of supplier and years since implementation.
How do you ensure consistency of potency levels from batch to batch
or tablet to tablet?
What level of accuracy of individual dosage do you aim for?
Within 10% of the labeled amount? 5%? 1%?
Some other type of range?
Does this accuracy range vary by product?
Do your product labels carry expiration dates? If so, how do you
determine the useful shelf life of specific products? Do your product
labels include information about beneficial storage conditions that
will help maintain or extend the product's useful shelf life?
Please provide an overview of your testing programs. Explain how
you guard against or test raw ingredients and/or final products
for the presence of:
Heavy metals, including lead
Herbicides, pesticides, and other agricultural chemicals
Organic and petroleum chemical contaminants
Steroids and antibiotics
Are materials and product testing performed in-house or by one or
more independent labs? Please describe the staffing level and equipment
complement of any in-house facilities. If you use external testing
resources, please provide nature of services.
At what stages of the manufacturing process do you test your products?
when raw materials arrive?
after manufacturing but before packaging?
What determines which formulations and/or substances you produce?
What guides the choice of ingredients you use in your products?
How do you determine levels of ingredients needed to produce a
clinically effective dose?
Do you perform your own research or undertake periodic literature
What professional credentials or life-experience credo are represented
by your product development group?
Do you provide customers with scientific information about the clinical
effectiveness of specific ingredients in your products?
What kind of information do you provide?
Do you maintain copies of published clinical studies for free
distribution? Do you undertake comparative analyses of scientific
Do you include information about negative findings as well as
Have the health benefits of the ingredients in your products been
published in a monograph or peer-reviewed journal?
What precautions do you take to make sure that consumers do not
accidentally take an excessive/toxic dose?
Are your products accompanied by cautions regarding toxic-dose
Do your product labels carry contraindications?
Do your product labels describe both appropriate and excessive
Do you have an internal system for reporting and/or investigating
adverse events? Do you report adverse incidents to a national
Describe your overall GMP program(s) in relation to meeting or exceeding
any of the following standards that apply to your company:
FDA's current GMP guidelines for dietary supplements
NNFA's GMP program requirements
CRN's GMP standards
OTC-level GMP standards
Pharmaceutical-level GMP standards
Other GMP standard?
If you do not currently participate in a GMP program, do you anticipate
entering one in the near future?
Describe your participation in any of the following programs or
eligibility for any of the following certification seals:
ConsumerLab's certification seal
Institute for Nutraceutical Advancement botanical testing
NNFA's TruLabel program
Paracelsian's BioFIT certification
USP disintegration and/or dissolution standards
Does your company belong to any trade associations? If so, which
one(s)? How long has your company been a member of each?
Background and Context
Is your company independently owned or part of a larger organization?
If the later is the case, please describe the nature of the owning
What is the overall size of your company? What is your approximate
number of employees?
number of products?
gross annual sales?
publicly-held or private company
Supplement production starts with either mining or growing the
materials from which supplements are made.
about asking the supplier:
chain: From raw materials to consumer shelves