Supplement Quality and Safety
to check on quality and contents:
http://www.supplementquality.com/
http://www.nsf.org/
Dr Scarlett speaking on 9/24 I think
"good quality" = ???
authenticity, pruity, potency, safety, efficacy
looking at 1st 3 today
label claims accurate
active, absorbable forms
potency/strength of ingredients
not contaminated or rancid
minimal fillers, binders, "excipients"
excipient = stuff added usu to facilitate manufacturing, marketing
flintstone vitamins: color, sugar, shape holding binders-->make it like candy, but vitamins are not highly absorbable, cheapest forms
plenty of unscrupulous manufacturers in the biz
big pharma makes supps too
bottom line is bottom line
VARIABLES
regulation
manufacturers
quality control depts
raw materials
production
testing
FDA REGULATION OF SUPPLEMENTS
DHSEA 1994 Dietary Supplement Health and Education Act
supps reg as foods not drugs (CFSAN)
labels must not be false/misleading
("this statement has not been evaluated by the FDA")
manufacturer ensures safety
FDA may prove "unsafe" after marketing
voluntary reporting of adverse events
agency of the United States Department of Health and Human Services
also regs tobacco, drugs/vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, vet products, and cosmetics
also enforces section 361 of the Public Health Service Act: interstate travel santitation, dz control on pets, sement, reprod medicine
NEW FDA REGS 2008
cGMP = current Good Manufacturing Practices 2008
raw materials must be tested for authenticity and purity
finished products must be tested for label claim and homogenicity
scientific testing methods
oversight personnel
personnel qualification, plant and grounds, equipment, operations,
production and process controls, warehouse, distribution
establish SOP: materials, process, measures, handling, yields, packaging, labeling
protect consumers from: adulterated prods, false labels, consistency probs, poor quality
doesn't cover safety and efficacy very well
21 CFS 111 mandates:
supp menufacturers must establish:
specs on product incl ID, purity, str, composition
process established and controleld
specs for materials
post testing
COMPLIANCE IS COSTLY
small co's may not be able to do everything even tho product is good
FDA allows ramp up time for co's under 20 employees
FDA DOESN'T DO MUCH ENFORCEMENT
suppliers are "exempt" from regs
loopholes
OTHER AGENCIES & SOURCES OF INFO
surf these
Naural Prods Assoc (was NNFA) has certificate prog, cGMP guidelines, audits, TruLabel program
www.naturalproductsassoc.org
TGA: Therapeutic Goods Administration (Australian) pharmacy-grade guidelines
www.tga.gov.au
US Pharmacopoea (US govt agency) guidelines/procedures for receiving, quarantine, micro testing, authenticity, potency testing, finished product verification, production cleanliness www.usp.org
FDA cGMPs www.cfsan.fda.gove
www.gpoaccess.gov/fr
NSF International -- testing/registration, covers lots of industries, choose supps in L column
www.nsf.org
MANUFACTURING
start to finish or composite of products bought from other sources?
outsourcing? partial or complete?
QUALITY ASSURANCE DEPARTMENT
staff size, qualifications, training
internal conflicts? (production vs production)
generate ans assure cGMP and SOP
choose procedures, sepcs, controls, test methods, raw materials, final products
keep records, run internal audits, arrange independent audits
RAW MATERIALS
supplier
quarantine on arrival
cert of analysis from supplier (COA)
verification by in house or independent testing
suppliers unregulated so cert of analysis (COA) mb falsified -->crucial to verify
info needed on botanicals: genus/spcs, what part, time harvested, storage method, organic/wildcraft, import? (fumigation), if liquid: extraction process (H2O, alc, solvent)
SUSTAINABILITY
procurement: ethical, legal, fair trade?, endangered?
extractions: pollution, toxins
packaging: pollution, estrogenic
ingredients made by co's that also make chems
local water supplies contaminated?
RAW MATERIAL TESTING
samples quarantined
verification mandated
high tech testing: gas chromatography, etc
microbial testing, rancidity of oils (anistidine, peroxide)
pesticides/fungicides, solvents, heavy metals
PRODUCTION
cGMP/SOP
caps (gel shell) vs tablets (binder, pharma glaze, worst absorptn) vs liquid (best absorption)
(need good acid to absorb cations: consider lemon or vinegar primer)
binders, excipients
fillers, diluentsm, flowing agents, lubricants
(silicone dioxide, mg stearate, ascorbyl palmitate)
forms of ingredients: price, absorbability, bulk, natural/sythetic
(cheap usu less absorbable/bioavailable: calcium carbonate, magnesium oxide)
(better chelators: amino acids, citrate, malate)
(B vitamins: it is in its active form? or inactive? which is better for what?)
(K2 esp for fx prevention)
natural vs synthetic (vit E better natural, vit C synthetic is fine, etc)
BATCH TESTING
consistency and potency
damage from heat of production?
contamination from machinery (cleaning solvent)
FINISHED PRODUCT
testing for "100% label claim"
tests for purity, composition, consistency
how and when batches are pulled
expiration date <--stability testing, desire to turn around stock
labels must follow FTC (Federal Trade Commission) laws
"every capsule contains..."
Canada has stricter label laws than US: "no sugar added" doesn't consider prior supplier in US
sample retention at least 3 years
lot number tracking (for recalls)
complaints and return policy
HOW WE CAN ASSURE A PRODUCT MEETS OUR STANDARDS
site visit
check what standard they (claim to) adhere to
ask about manufacturing: outsourcing?
quality assurance dept?
sustainable harvest?
reasonable packaging?
http://www.supplementquality.com/
http://www.nsf.org/
Dr Scarlett speaking on 9/24 I think
"good quality" = ???
authenticity, pruity, potency, safety, efficacy
looking at 1st 3 today
label claims accurate
active, absorbable forms
potency/strength of ingredients
not contaminated or rancid
minimal fillers, binders, "excipients"
excipient = stuff added usu to facilitate manufacturing, marketing
flintstone vitamins: color, sugar, shape holding binders-->make it like candy, but vitamins are not highly absorbable, cheapest forms
plenty of unscrupulous manufacturers in the biz
big pharma makes supps too
bottom line is bottom line
VARIABLES
regulation
manufacturers
quality control depts
raw materials
production
testing
FDA REGULATION OF SUPPLEMENTS
DHSEA 1994 Dietary Supplement Health and Education Act
supps reg as foods not drugs (CFSAN)
labels must not be false/misleading
("this statement has not been evaluated by the FDA")
manufacturer ensures safety
FDA may prove "unsafe" after marketing
voluntary reporting of adverse events
agency of the United States Department of Health and Human Services
also regs tobacco, drugs/vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, vet products, and cosmetics
also enforces section 361 of the Public Health Service Act: interstate travel santitation, dz control on pets, sement, reprod medicine
NEW FDA REGS 2008
cGMP = current Good Manufacturing Practices 2008
raw materials must be tested for authenticity and purity
finished products must be tested for label claim and homogenicity
scientific testing methods
oversight personnel
personnel qualification, plant and grounds, equipment, operations,
production and process controls, warehouse, distribution
establish SOP: materials, process, measures, handling, yields, packaging, labeling
protect consumers from: adulterated prods, false labels, consistency probs, poor quality
doesn't cover safety and efficacy very well
21 CFS 111 mandates:
supp menufacturers must establish:
specs on product incl ID, purity, str, composition
process established and controleld
specs for materials
post testing
COMPLIANCE IS COSTLY
small co's may not be able to do everything even tho product is good
FDA allows ramp up time for co's under 20 employees
FDA DOESN'T DO MUCH ENFORCEMENT
suppliers are "exempt" from regs
loopholes
OTHER AGENCIES & SOURCES OF INFO
surf these
Naural Prods Assoc (was NNFA) has certificate prog, cGMP guidelines, audits, TruLabel program
www.naturalproductsassoc.org
TGA: Therapeutic Goods Administration (Australian) pharmacy-grade guidelines
www.tga.gov.au
US Pharmacopoea (US govt agency) guidelines/procedures for receiving, quarantine, micro testing, authenticity, potency testing, finished product verification, production cleanliness www.usp.org
FDA cGMPs www.cfsan.fda.gove
www.gpoaccess.gov/fr
NSF International -- testing/registration, covers lots of industries, choose supps in L column
www.nsf.org
MANUFACTURING
start to finish or composite of products bought from other sources?
outsourcing? partial or complete?
QUALITY ASSURANCE DEPARTMENT
staff size, qualifications, training
internal conflicts? (production vs production)
generate ans assure cGMP and SOP
choose procedures, sepcs, controls, test methods, raw materials, final products
keep records, run internal audits, arrange independent audits
RAW MATERIALS
supplier
quarantine on arrival
cert of analysis from supplier (COA)
verification by in house or independent testing
suppliers unregulated so cert of analysis (COA) mb falsified -->crucial to verify
info needed on botanicals: genus/spcs, what part, time harvested, storage method, organic/wildcraft, import? (fumigation), if liquid: extraction process (H2O, alc, solvent)
SUSTAINABILITY
procurement: ethical, legal, fair trade?, endangered?
extractions: pollution, toxins
packaging: pollution, estrogenic
ingredients made by co's that also make chems
local water supplies contaminated?
RAW MATERIAL TESTING
samples quarantined
verification mandated
high tech testing: gas chromatography, etc
microbial testing, rancidity of oils (anistidine, peroxide)
pesticides/fungicides, solvents, heavy metals
PRODUCTION
cGMP/SOP
caps (gel shell) vs tablets (binder, pharma glaze, worst absorptn) vs liquid (best absorption)
(need good acid to absorb cations: consider lemon or vinegar primer)
binders, excipients
fillers, diluentsm, flowing agents, lubricants
(silicone dioxide, mg stearate, ascorbyl palmitate)
forms of ingredients: price, absorbability, bulk, natural/sythetic
(cheap usu less absorbable/bioavailable: calcium carbonate, magnesium oxide)
(better chelators: amino acids, citrate, malate)
(B vitamins: it is in its active form? or inactive? which is better for what?)
(K2 esp for fx prevention)
natural vs synthetic (vit E better natural, vit C synthetic is fine, etc)
BATCH TESTING
consistency and potency
damage from heat of production?
contamination from machinery (cleaning solvent)
FINISHED PRODUCT
testing for "100% label claim"
tests for purity, composition, consistency
how and when batches are pulled
expiration date <--stability testing, desire to turn around stock
labels must follow FTC (Federal Trade Commission) laws
"every capsule contains..."
Canada has stricter label laws than US: "no sugar added" doesn't consider prior supplier in US
sample retention at least 3 years
lot number tracking (for recalls)
complaints and return policy
HOW WE CAN ASSURE A PRODUCT MEETS OUR STANDARDS
site visit
check what standard they (claim to) adhere to
ask about manufacturing: outsourcing?
quality assurance dept?
sustainable harvest?
reasonable packaging?