OMB Control Number 0910-0891 Expiration Date: 09/30/2026
Dietary Supplement Claims One-on-one In-depth Interview Study
Attachment 6 – Structure of Interview (for review only)
Note: Each study participant will be randomly assigned to one of the four groups, using four different versions of slides (an example is shown in Attachment 7, Version 1 for Group 1). We will aim for 15 participants for each of the four groups and a balanced mix of dietary supplement users and non-users in each group.
Groups 1 and 2 will be discussing sugar/glucose related claims first (using, for example, Slides 1-5 as shown in Attachment 7) and hypertension related claims next (Slides 6-11 as shown in Attachment 7). The two groups will see different claims for each of the health conditions and different orders of claims for a given condition (Slide 11).
Groups 3 and 4 will be discussing hypertension related claims first and sugar/glucose related claims next. The two groups will cover different claims for each of the health conditions and different orders of claims for a given condition (Slide 11).
Group 1 (sugar/glucose first, hypertension next) |
Group 2 (sugar/glucose first, hypertension next) |
Group 3 (hypertension first, sugar/glucose next) |
Group 4 (hypertension first, sugar/glucose next) |
Slide 1 – label 1A1-Interpret a structure/function (SF) claim, sugar
Name – Advanced blood sugar formula*
Claim - A2. Promotes healthy blood glucose levels* (w/disclaimer)” |
Slide 1 – label 2A1-Interpret a structure/function (SF) claim, sugar
Name – Advanced blood sugar formula*
Claim – A5. Supports glucose metabolism* (w/disclaimer) |
Slide 1 – label 3A1 -Interpret a structure/function (SF) claim, hypertension
Name – E4. BP Stability*
Claim – B3. Maintains healthy blood pressure and healthy blood flow* (w/disclaimer) |
Slide 1 – label 4A1 -Interpret a structure/function (SF) claim, hypertension
Name – Advanced blood pressure formula*
Claim - B5. Supports blood vessel dilation which in turn supports healthy blood pressure levels and healthy blood flow* (w disclaimer) |
Slide 2 – label 1A2-Interpret same SF claim with different name, sugar
Name – F8. Glucose health*
Claim - A2. Promotes healthy blood glucose levels* (w/disclaimer) |
Slide 2 – label 2A2 -Interpret same SF claim, with different name, sugar
Claim – A5. Supports glucose metabolism* (w/disclaimer)
Name - F9. Insulin health* |
Slide 2 – label 3A2 -Interpret same SF claim, with different name, hypertension
Name – E3. Healthy blood pressure Support*
Claim – B3. Maintains healthy blood pressure and healthy blood flow* (w/disclaimer) |
Slide 2 – label 4A2 -Interpret same SF claim, with different name, hypertension
Name – E4. BP stability*
Claim - B5. Supports blood vessel dilation which in turn supports healthy blood pressure levels and healthy blood flow* (w disclaimer) |
Slide 3 – labels 1A2 and 1A3 - Compare a pair of SF claims, sugar
Claims - A2. Promotes healthy blood glucose levels* (w/disclaimer)” vs A8. Healthy insulin usage* (w/disclaimer)
Name - F8. Glucose Health* |
Slide 3 – labels 2A2 and 2A3 - Compare a pair of SF claims, sugar
Claims – A5. Supports glucose metabolism* (w/disclaimer) vs A3. Helps maintain healthy sugar levels* (w/disclaimer)
Name - F9. Insulin Health* |
Slide 3 – labels 3A2 and 3A3 - Compare a pair of SF claims, hypertension
Claims – B3. Maintains healthy blood pressure and healthy blood flow* (w/disclaimer) vs B4. Promotes healthy blood pressure already within normal range* (w/disclaimer)
Name – E3. Healthy blood pressure support* |
Slide 3 – labels 4A2 and 4A3 - Compare a pair of SF claims, hypertension
Claims – B5. Supports blood vessel dilation which in turn supports healthy blood pressure levels and healthy blood flow* (w disclaimer) vs B2. Maintains normal blood pressure levels* (w/disclaimer)
Name - E4. BP stability* |
Slide 4 – labels 1A4 and 1A5 - Compare 2 disease claims, only one label has the disclaimer, sugar
Claims – D7. Control blood sugars* (w/disclaimer)” vs D6 Glucose management* (w/o disclaimer)
Name - F5. Blood Sugar Special Formulation* |
Slide 4 – labels 2A4 and 2A5 - Compare 2 disease claims, only one label has the disclaimer, sugar
Claims – D9. Improves plasma glucose levels* (w/disclaimer) vs D3. Helps regulate blood sugar levels* (w/o disclaimer)
Name – F4. Sugar Shield* |
Slide 4 – labels 3A4 and 3A5 - Compare 2 disease claims, only one label has the disclaimer, hypertension
Claims – C4. Powerful in restoring normal blood pressure* (w/disclaimer) vs C1. May be beneficial for moderating blood pressure* (w/o disclaimer)
Name – E1. BP support* |
Slide 4 – labels 4A4 and 4A5 - Compare 2 disease claims, only one label has the disclaimer, hypertension
Claims - C3. supports blood pressure regulation* (w/disclaimer) vs C4. Powerful in restoring normal blood pressure* (w/o disclaimer)
Name - E6. BP Health* |
Slide 5 – card sort, sugar
Claims – SF and disease claims |
Slide 5 – card sort, sugar
Claims – SF and disease claims |
Slide 5 – card sort, hypertension
Claims – SF and disease claims |
Slide 5 – card sort, hypertension
Claims – SF and disease claims |
Slide 6 - card sort, hypertension
Claims – SF and disease claims |
Slide 6 – card sort, hypertension
Claims – SF and disease claims |
Slide 6 – card sort, sugar
Claims – SF and disease claims |
Slide 6 – card sort, sugar
Claims – SF and disease claims |
Slide 7 – label 1B1 -Interpret a SF claim, hypertension
Claim – B1. Supports Blood Pressure* (w/disclaimer)”
Name – E6. BP Health* |
Slide 7 – label 2B1-Interpret a SF claim, hypertension
Claim – B4. Promotes healthy blood pressure already within normal range* (w/disclaimer)
Name – E6. BP Health* |
Slide 7 – label 3B1 - Interpret a SF claim, sugar
Claim – A8. Healthy insulin usage* (w/disclaimer)
Name – F6. Blood glucose 365* |
Slide 7 – label 4B1 -Interpret a SF claim, sugar
Claim - A4. Support for healthy glucose metabolism* (w/disclaimer)
Name – Advanced blood sugar formula* |
Slide 8 – label 1B2 -Interpret same SF claim, different name, hypertension
Claim – B1. Supports Blood Pressure* (w/disclaimer)”
Name - E7. Blood pressure formula* |
Slide 8 – label 2B2-Interpret same SF claim, different name, hypertension
Claim – B4. Promotes healthy blood pressure already within normal range* (w/disclaimer)
Name – E2. Blood Pressure Support* |
Slide 8 – label 3B2 - Interpret same SF claim, different name, sugar
Claim - A8. Healthy insulin usage* (w/disclaimer)
Name – F3. Blood sugar support* |
Slide 8 – label 4B2 - Interpret same SF claim, different name, sugar
Claim - A4. Support for healthy glucose metabolism* (w/disclaimer)
Name - F9. Insulin Health* |
Slide 9 - labels 1B2 and 1B3, Compare a pair of SF claims, hypertension
Claims – B1. Supports blood pressure* (w/disclaimer) vs B2 Maintains normal blood pressure levels* (w/disclaimer)
Name - E7. Blood pressure formula* |
Slide 9 – labels 2B2 and 2B3, Compare a pair of SF claims, hypertension
Claims – B4. Promotes healthy blood pressure already within normal range* vs B2. Maintains normal blood pressure levels*
Name – E2. Blood Pressure Support* |
Slide 9 – labels 3B2 and3B3 - Compare a pair of SF claims, sugar
Claims - A8. Healthy insulin usage* (w/disclaimer) vs A4. Support for healthy glucose metabolism* (w/disclaimer)
Name – F3. Blood sugar support* |
Slide 9 – labels 4B2 and 4B3 -Compare a pair of SF claims, sugar
Claims - A4. Support for healthy glucose metabolism* (w/disclaimer) vs A9. Promotes insulin production by supporting pancreatic cells* (w/disclaimer)
Name - F9. Insulin Health* |
Slide 10 – labels 1B2 and 1B4 - Compare 2 SF claims, only one label has the disclaimer, hypertension
Claims – B1. Supports Blood Pressure* (w/disclaimer) vs B5. Supports blood vessel dilation which in turn supports healthy blood pressure levels and healthy blood flow* (w/o disclaimer)
Name – E7. Blood Pressure Formula* |
Slide 10 – labels 2B4 and 2B5 - Compare 2 disease claims, only one label has the disclaimer, hypertension
Claims – C9. Regulates and maintains healthy blood pressure and cholesterol levels* (w/disclaimer) vs C2. Plays a role in controlling blood pressure* (w/o disclaimer)
Name – E8. Blood Pressure Elements* |
Slide 10 – labels 3B4 and 3B5 - Compare 2 disease claims, only one label has the disclaimer, sugar
Claims – D8. Reduces plasma glucose level* (w/disclaimer) vs D4. Regulates healthy blood sugar levels* (w/o disclaimer)
Name – F1. Sugar break* |
Slide 10 – labels 4B2 and 4B4 - Compare 2 SF claims, only one label has the disclaimer, sugar
Claims - A4. Support for healthy glucose metabolism* (w/disclaimer) vs A9. Promotes insulin production by supporting pancreatic cells* (w/o disclaimer)
Name - F9. Insulin Health* |
Slide 11 – compare two claims – hypertension
Maintains blood pressure levels
Maintains normal blood pressure levels |
Slide 11 – compare two claims – hypertension
Maintains normal blood pressure levels
Maintains blood pressure levels |
Slide 11 – compare two claims – sugar
Support glucose metabolism
Support for healthy glucose metabolism |
Slide 11 – compare two claims – sugar
Support for healthy glucose metabolism
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File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Hardy, Constance J (CFSAN) |
File Modified | 0000-00-00 |
File Created | 2024-07-21 |