User's Manual

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7.6 FDA CONSUMER UPDATE
ƚŚĞƵƐĞƌ͛ƐŚĞĂĚ͘dŚĞƐĞZ&ĞdžƉŽƐƵƌĞƐĂƌĞůŝŵŝƚĞĚďLJ&ĞĚĞƌĂůŽŵŵƵŶŝĐĂƟŽŶƐŽŵŵŝƐƐŝŽŶƐĂĨĞƚLJ
ŐƵŝĚĞůŝŶĞƐƚŚĂƚǁĞƌĞĚĞǀĞůŽƉĞĚǁŝƚŚƚŚĞĂĚǀŝĐĞŽĨ&ĂŶĚŽƚŚĞƌĨĞĚĞƌĂůŚĞĂůƚŚĂŶĚƐĂĨĞƚLJ
ĂŐĞŶĐŝĞƐ͘tŚĞŶƚŚĞƉŚŽŶĞŝƐůŽĐĂƚĞĚĂƚŐƌĞĂƚĞƌĚŝƐƚĂŶĐĞƐĨƌŽŵƚŚĞƵƐĞƌ͕ƚŚĞĞdžƉŽƐƵƌĞƚŽZ&ŝƐ
ĚƌĂƐƟĐĂůůLJůŽǁĞƌďĞĐĂƵƐĞĂƉĞƌƐŽŶ͛ƐZ&ĞdžƉŽƐƵƌĞĚĞĐƌĞĂƐĞƐƌĂƉŝĚůLJǁŝƚŚŝŶĐƌĞĂƐŝŶŐĚŝƐƚĂŶĐĞĨƌŽŵ
ƚŚĞƐŽƵƌĐĞ͘dŚĞƐŽͲĐĂůůĞĚ͞ĐŽƌĚůĞƐƐƉŚŽŶĞƐ͕͟ǁŚŝĐŚŚĂǀĞĂďĂƐĞƵŶŝƚĐŽŶŶĞĐƚĞĚƚŽƚŚĞƚĞůĞƉŚŽŶĞ
ǁŝƌŝŶŐŝŶĂŚŽƵƐĞ͕ƚLJƉŝĐĂůůLJŽƉĞƌĂƚĞĂƚĨĂƌůŽǁĞƌƉŽǁĞƌůĞǀĞůƐ͕ĂŶĚƚŚƵƐƉƌŽĚƵĐĞZ&ĞdžƉŽƐƵƌĞƐĨĂƌ
ďĞůŽǁƚŚĞ&ƐĂĨĞƚLJůŝŵŝƚƐ͘
4. What are the results of the research done already?
dŚĞƌĞƐĞĂƌĐŚĚŽŶĞƚŚƵƐĨĂƌŚĂƐƉƌŽĚƵĐĞĚĐŽŶŇŝĐƟŶŐƌĞƐƵůƚƐ͕ĂŶĚŵĂŶLJƐƚƵĚŝĞƐŚĂǀĞƐƵīĞƌĞĚĨƌŽŵ
ŇĂǁƐŝŶƚŚĞŝƌƌĞƐĞĂƌĐŚŵĞƚŚŽĚƐ͘ŶŝŵĂůĞdžƉĞƌŝŵĞŶƚƐŝŶǀĞƐƟŐĂƟŶŐƚŚĞĞīĞĐƚƐŽĨƌĂĚŝŽĨƌĞƋƵĞŶĐLJ
ĞŶĞƌŐLJ;Z&ͿĞdžƉŽƐƵƌĞƐĐŚĂƌĂĐƚĞƌŝƐƟĐŽĨǁŝƌĞůĞƐƐƉŚŽŶĞƐŚĂǀĞLJŝĞůĚĞĚĐŽŶŇŝĐƟŶŐƌĞƐƵůƚƐƚŚĂƚŽŌĞŶ
ĐĂŶŶŽƚďĞƌĞƉĞĂƚĞĚŝŶŽƚŚĞƌůĂďŽƌĂƚŽƌŝĞƐ͘ĨĞǁĂŶŝŵĂůƐƚƵĚŝĞƐ͕ŚŽǁĞǀĞƌ͕ŚĂǀĞƐƵŐŐĞƐƚĞĚƚŚĂƚ
ůŽǁůĞǀĞůƐŽĨZ&ĐŽƵůĚĂĐĐĞůĞƌĂƚĞƚŚĞĚĞǀĞůŽƉŵĞŶƚŽĨĐĂŶĐĞƌŝŶůĂďŽƌĂƚŽƌLJĂŶŝŵĂůƐ͘
,ŽǁĞǀĞƌ͕ŵĂŶLJŽĨƚŚĞƐƚƵĚŝĞƐƚŚĂƚƐŚŽǁĞĚŝŶĐƌĞĂƐĞĚƚƵŵŽƌĚĞǀĞůŽƉŵĞŶƚƵƐĞĚĂŶŝŵĂůƐƚŚĂƚŚĂĚ
ďĞĞŶŐĞŶĞƟĐĂůůLJĞŶŐŝŶĞĞƌĞĚŽƌƚƌĞĂƚĞĚǁŝƚŚĐĂŶĐĞƌͲĐĂƵƐŝŶŐĐŚĞŵŝĐĂůƐƐŽĂƐƚŽďĞƉƌĞĚŝƐƉŽƐĞĚƚŽ
ĚĞǀĞůŽƉĐĂŶĐĞƌŝŶƚŚĞĂďƐĞŶĐĞŽĨZ&ĞdžƉŽƐƵƌĞ͘KƚŚĞƌƐƚƵĚŝĞƐĞdžƉŽƐĞĚƚŚĞĂŶŝŵĂůƐƚŽZ&ĨŽƌƵƉƚŽ
ϮϮŚŽƵƌƐƉĞƌĚĂLJ͘dŚĞƐĞĐŽŶĚŝƟŽŶƐĂƌĞŶŽƚƐŝŵŝůĂƌƚŽƚŚĞĐŽŶĚŝƟŽŶƐƵŶĚĞƌǁŚŝĐŚƉĞŽƉůĞƵƐĞ
ǁŝƌĞůĞƐƐƉŚŽŶĞƐ͕ƐŽǁĞĚŽŶ͛ƚŬŶŽǁǁŝƚŚĐĞƌƚĂŝŶƚLJǁŚĂƚƚŚĞƌĞƐƵůƚƐŽĨƐƵĐŚƐƚƵĚŝĞƐŵĞĂŶĨŽƌ
ŚƵŵĂŶŚĞĂůƚŚ͘dŚƌĞĞůĂƌŐĞĞƉŝĚĞŵŝŽůŽŐLJƐƚƵĚŝĞƐŚĂǀĞďĞĞŶƉƵďůŝƐŚĞĚƐŝŶĐĞĞĐĞŵďĞƌϮϬϬϬ͘
ĞƚǁĞĞŶƚŚĞŵ͕ƚŚĞƐƚƵĚŝĞƐŝŶǀĞƐƟŐĂƚĞĚĂŶLJƉŽƐƐŝďůĞĂƐƐŽĐŝĂƟŽŶďĞƚǁĞĞŶƚŚĞƵƐĞŽĨǁŝƌĞůĞƐƐ
ƉŚŽŶĞƐĂŶĚƉƌŝŵĂƌLJďƌĂŝŶĐĂŶĐĞƌ͕ŐůŝŽŵĂ͕ŵĞŶŝŶŐŝŽŵĂ͕ŽƌĂĐŽƵƐƟĐŶĞƵͲƌŽŵĂ͕ƚƵŵŽƌƐŽĨƚŚĞďƌĂŝŶ
ŽƌƐĂůŝǀĂƌLJŐůĂŶĚ͕ůĞƵŬĞŵŝĂ͕ŽƌŽƚŚĞƌĐĂŶĐĞƌƐ͘EŽŶĞŽĨƚŚĞƐƚƵĚŝĞƐĚĞŵŽŶƐƚƌĂƚĞĚƚŚĞĞdžŝƐƚĞŶĐĞŽĨ
ĂŶLJŚĂƌŵĨƵůŚĞĂůƚŚĞīĞĐƚƐĨƌŽŵǁŝƌĞůĞƐƐƉŚŽŶĞZ&ĞdžƉŽƐƵƌĞƐ͘,ŽǁĞǀĞƌ͕ŶŽŶĞŽĨƚŚĞƐƚƵĚŝĞƐĐĂŶ
ĂŶƐǁĞƌƋƵĞƐƟŽŶƐĂďŽƵƚůŽŶŐͲƚĞƌŵĞdžƉŽƐƵƌĞƐ͕ƐŝŶĐĞƚŚĞĂǀĞƌĂŐĞƉĞƌŝŽĚŽĨƉŚŽŶĞƵƐĞŝŶƚŚĞƐĞ
studies was around three years.