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Re: Art Vandeley post# 182358

Thursday, 03/05/2015 12:45:25 PM

Thursday, March 05, 2015 12:45:25 PM

Post# of 238564

Additionally, your marketed products “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], because the labeling for these products fails to bear adequate directions for use...
Because the above-mentioned products lack FDA-approved applications, they are not exempt under 21 CFR §§ 201.100(c)(2) and 201.115. For these reasons, these products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].



It's both the marketing AND the product labels themselves are that problematic for the FDA.

Their words, not mine.