Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(B)]. Your walnut products are also new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], they may not be legally marketed with the above claims in the United States without an approved new drug application. Additionally, your walnut products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your walnut products are also misbranded under section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. [More]
Dear Parasites,
I guess if stupid unelected bureaucrats can declare
Chore Boy scrubber pads are firearms under the right set of conditions, you two "just following orders"
Ilsa wannabes can classify walnuts as drugs and make threats backed by force of state arms. Way to go securing the blessings of Liberty there, gals--but why bring up the Constitution? It's not like it has any bearing on your activities.
This is public notice that I am in possession of illicit walnut drugs and am administering them without any license to my family and advising them that eating them is good and healthy for them. In other words, that is, in your words, I am "a layperson us[ing] these drugs," obviously, if you are to be believed,
unsafely "for their intended purposes."
Something must be done!
Be advised I am defying you and will continue to do so until you send someone to stop me--before I do it again! Also be advised that I will not go willingly, so bring a lunch (and make sure you include plenty of delicious, healthy walnuts!).
Jeez, next thing you know, petty government tyrant wannabes will be telling us
water doesn't hydrate or some such foolishness, like we're Europe or something.
Some growers in CA pronounce almonds "ammonds" because, to get them out of the tree you have to knock the "l" out of them--prompting a friend to ask if we should call walnuts "whaaanuts" ("a" as in "and").
Whaanuts. Sounds like you two
In all sincerity,
David Codrea