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Assessment of Dietary Supplement Use in New Zealand: Methodological and Regulatory Challenges W Parnell, A van Rij, C Blakey, L Fleming, J Mahood Department of Human Nutrition University of Otago, New Zealand
Supplement data collected as part of the 2008/09 Adult Nutrition Survey funded by the Ministry of Health
What are Dietary Supplements? Originally additions to the diet to remedy nutrient(s) deficiency Current definitions*: A product intended for use by humans to maintain and promote health, containing 1 or more of the following: vitamin, mineral, herb/botanical, amino acid * Dietary Supplement Health & Education Act (DSHEA) Public Law 103-417 (1994)
World wide interest in Dietary Supplements Nutrition Scientists Who conclude that there is no data to support their use to benefit health with some country specific exceptions (Malik & Flemmer, J Parenteral & Enteral Nutrition 2012;36(2):159-168) Manufacturers Who produce increasing varieties and promote them widely (cont d)
World wide interest in Dietary Supplements (cont d) Consumers Who take supplements for a wide variety of reasons, accessing them from stores, via internet, pyramid sales Regulators Who take responsibility for ensuring their safety, including accuracy of labelling and?efficacy/claims
Agreement among nutrition scientists that Dietary Supplement use be monitored To assess safety: Do intakes of vitamins or minerals exceed ULs? Within surveys of dietary intake the contribution of supplements must be included Consensus that supplements claiming efficacy should have an evidence base
Dietary Supplement use in New Zealand (NZ) National data for adults 15+ years collected in 1997 (n=4636), and in 2008/09 (n=4721) Definition used: open, i.e. whatever the Survey participant considers to be a supplement to their diet Data collected in participant s home
NZ population 15+ yrs: % use of Dietary Supplement(s) 1997 2008/09 Any use, past yr M 50.4 41.9 F 67.6 53.0 Use of 1 or more in previous 24 hrs M 17.8 8.9 F 30.5 13.1
Despite Increasing variety of supplements available Vigorous advertising But frequency of supplement use has declined What has changed about the type of supplement chosen?
NZ population 15+ yrs: Type of Supplement chosen (previous yr) 1997 2008/09 Multivitamins/ minerals M 14.3 10.6 F 25.3 18.6 Oils* M 0.4 13.7 F 6.9 18.9 * 1997: Evening Primrose Oil 2008/09: Fish oils; Omega 3, 6 9; Flax/linseed oil; Evening Primrose Oil
New Zealand s Methods - overview 1. Recall Frequency 2. Pre-categorise vs Free text collection of supplement type 3. Assigning Nutrient composition for supplements
Recall Frequency Supplement data collected in 2 ways: (i) Use over past year (frequency & type) (ii) Use in previous 24 hrs (as part of 24 hr diet recall)
Recall over one year Participants able to encapsulate use across all seasons of the year Presented with Frequency bands : 1997 2008/09 Less than 1x month Infrequent/irregular 1x per week >1 per week Daily Episodic* DK * Defined as regular use for limited time period
Attempts to pre-categorise Supplement type 1997 experience: Needed high level of interviewer ability to correctly assign to a named type, e.g. - Multivitamins or minerals - Herbal/botanical - Herbal/botanical + vitamins & minerals Particularly difficult when container could not be sighted
2008/09 Simplified list of categories Preferred approach to sight container and have interviewer record details in a Comment box * Supplements assigned to a category by Project Office staff post-data collection * Brand name, product name, dose, strength
Comment box examples Red Seal, Executive B Stress, 60 tablets Multivitamin, B1 100 mg, B2 15 mg, B3 100 mg, B5 100 mg, B6 25 mg, B12 25 mcg 9400581017489 Kordels Senior Time, multivit/mineral 9400581008715 Kordels Joint Food 9400581017335 Kordels Omega 3 Marine Fish Oil 9400581017663 Nutralife Enzogenol, multivit/mineral + herb 9400581005271 Wagner Kyolic Aged Garlic extract, herbal 9400581011449 Nutralife Co-Q Max Heart Health Formula
Nutrient matching of supplements consumed in 24 hr diet recall period Database of products was compiled Nutrients listed in same format/units as the food composition database Nutrients recorded: Per tablet/capsule/drop Per 100 g powder form Per 100 ml liquid form Units were standardized Amounts of minerals calculated from salts
Sources of information to ascertain composition Interviewers record (from participant s description)was the starting point Details were checked using : - Websites of manufacturers, distributors, pharmaceutical companies - Where no brand was specified, item was matched to the most frequently used brand of the same kind 1122 items were matched to a nutrient line 50 (4%) could not be linked
Strengths of data collection method For products consumed in previous 24 hrs container usually viewed Interviewers not required to be familiar with wide range of products consumed Nutrient matching not dependent on existing supplement database where currency is questionable Enabled calculation of nutrient intake from FOODS & SUPPLEMENTS consumed in same 24 hr period
Regulatory approaches These vary depending on whether Dietary Supplements are considered to be: - A supplement to nutrient intake - Complementary or alternative medicines - Essential for health or likely to enhance health
Regulatory approaches (cont) New Zealand s current situation: Dietary Supplement Regulations (1985) for Vitamins and Minerals ( amendment 2010) Consequent importing, production and promotion of wide range of products Current consideration of draft regulations Natural Health Products (Canadian model) Lack of agreement re legislation with Australia with whom we have a common Food Standards Code
Conclusions Important to collect national data on consumption of Dietary Supplements to enable: Proper consideration of safety issues (food & supplements), particularly among consumers of multiple products Drafting of appropriate legislation Best possible evaluation of dietary intake
Population intakes of selected nutrients the influence of Supplements Without With Vitamin B6 (mg) M 2.5 3.4* F 1.8 3.6* Vitamin C (mg) M 109 138* F 105 155* Vitamin E (mg) M 12.0 14.0* F 9.4 12.0* Fe (mg) M 14.0 14.1 F 10.0 11.25* * Significantly higher 95% CI did not overlap