Big Pharma's FDA: Guest Bureaucrat Alonza Cruse

Below is one-third of a warning letter that demands a company to change its evil ways under the US Code.

The company makes a pill with cinnamon, D-3, and fish oil.  There are hundreds of studies that reflect that these foods work with insulin sensitivity.  I know, I have all three all the time; however, the FDA has decided the "article" is a medicine and cannot be sold as it is.  I guess one is supposed to get prescription for food. I cam across this busybody letter while researching the product.

Mr. Alonza is on the left.  I hate to report it, but he seems like a nice guy. At the bottom is a link to a home-made video of a lecture on management that he gave. ZZZ

First let me whet your appetite:

FEBRUARY 27--The manufacturers of a powdered energy drink mix called 'Blow' are violating federal drug guidelines, according to the Food and Drug Administration, which notes that products peddled as an 'alternative to illicit street drugs pose a potential threat to the public health.' 

FDA officials contend that 'Blow' is an unapproved drug that is being marketed online (at iloveblow.com) in a way to draw comparisons to cocaine. In a warning letter, Alonza Cruse, director of the FDA's Los Angeles office, charged that the white powdery mix is packaged 'in a vial suggestive of street drug paraphernalia' and that photos of the product make it appear that the mix has been cut into 'very fine particles to increase the efficiency of nasal absorption prior to insufflation, i.e., snorting.' 

The January 31 FDA letter, a copy of which you'll find here, advises that unless the manufacturer of 'Blow' quickly cures its violations of the Federal Food, Drug, and Cosmetic Act, the company risks legal action and seizure of its product. A call to Logan Gola, who runs the company selling 'Blow' was not returned at press time 

Since its introduction last year, the energy drink mix has been criticized by law enforcement officers and drug prevention specialists, who have claimed that 'Blow' glamorizes drug use and is marketed to children. (3 pages)

One wonders what the FDA is supposed to regulate?  Sounds like it takes orders from ex-mayor Blumberg. After the excerpt of the next weird warning letter, you will find the statute behind all this.

July 15, 2013

WL # 47 - 13

Neuliven Health, Inc.

Attn: Lee Zhong, M.D., Ph.D.

10171 Pacific Mesa Blvd.

Suite # 302

San Diego, CA 92121

Dear Dr. Zhong:

                                                                             

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website, www.glucocil.com in April 2013 and has determined that you take orders there for the product, Glucocil, which the website promotes for conditions that cause this product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.

Unapproved New Drugs

Examples of the claims noted on your website include the following:

On the homepage “Glucocil’s ingredients help you naturally and safely:”

•  “Lower fasting blood sugar levels up to 29%”

•  “Lower A1c levels significantly”

• “Since using Glucocil, my blood sugar level has been under control.” 

• “Glucocil helps stabilize your blood sugar all day, without adding a drug!” 

• “The average decrease I see in my patients’ glucose spike at 45 minutes is 50-75 points. With that kind of decrease in the glucose spike, the blood glucose levels are much easier to control.” 

• “Glucocil has the natural and safe ingredients clinically proven to help manage blood sugar levels.” 

• “After trying many natural remedies to lower and stabilize blood sugar levels, I have found Glucocil to be the only product that performs remarkable results.”

On the webpage titled, “How it Works”:

• “Glucocil is a natural supplement specifically designed to help prediabetics and type 2 diabetics: 

› Lower blood sugar & A1c levels …”

• “Clinical studies show that Glucocil ingredients:

               Lower fasting blood sugar levels up to 35% …

               Lower A1c levels up to 21%”

On the webpage titled, “Ingredients”

• “Cinnamon Bark Powder…Cinnamon has been shown to reduce fasting serum glucose … and total and LDL-cholesterol concentrations in patients with type 2 diabetes. More specifically, studies have found that cinnamon powder not only reduces fasting blood sugar levels up to 29%, but also significantly reduces A1c levels.” 

• “Fish Oil… It is also known that a high fish intake can delay the development of diabetes in glucose-intolerant individuals.”

• “Vitamin D… Studies suggest that high levels of vitamin D helps reduce the risk of developing cardiovascular diseases by 33 percent, type 2 diabetes by 55 percent …”

================

Credit where it is due:

...Please send your reply to the attention of Dr. Raymond W. Brullo, Compliance Officer, Food and Drug Administration, Los Angeles District Office, 19701 Fairchild, Irvine, CA 92612. If you have any questions regarding any issue in this letter, please contact Dr. Brullo at (949) 608-2918.

Sincerely,

/S/ 

Alonza Cruse, Director

Los Angeles District

     (Can't sleep - watch his  lecture)    

cc: Litao Zhong

     7340 A Trade St,

     San Diego, CA 92121

==========

What is amazing is this law, below, fails basic grammatical investigation. According to the law in (g)(1), items A,B,C,D are joined in the conjunctive. That means ALL conditions are required to define a drug. Of course, to confuse analysis more a semi colon is thrown into the mix;  this would only be proper where there is a new, related sentence or a series is being spelled out. Neither is the case. In the current world of discretionary law, the courts, I am sure, will rewrite the words of the Congress so it fits what they think it should say.

Anyway, there are many medical companies and doctors who make good money selling drugs that, albeit with horrible side effects, have been approved by other doctors who are related to big companies. So, adding the three foods together make it a drug.  Nonsense. This is big pharma and little Marxists. I was forced to submit to Warfarin once until I read the NIH said it was stupid to do so, just take a baby aspirin.  No money in that, is there?

I have read many studies (OK, the abstracts) that confirm the reports in the advertisement given. The studies recommend eating certain foods or taking so many grams of an extract. So, here is a company selling the extract that the US government attacks.  The evil, violative words actually say the product is a natural supplement.  Duh!  Where is the sale of a "drug?"    

Why is the FDA even involved in cinnamon?  Because it says so?  Clearly, aspirin and cinnamon are a threat to east money from drugs.

I am making more coffee, now, and will add cinnamon and  take my D-3 pill.  I hope the NSA isn't tracking me.  I just realized I have ginger snaps.  Ginger is good for one, too,  Yikes!

===================

SEC. 201. [21 U.S.C. 321]

CHAPTER II—DEFINITIONS 1

  SEC. 201. [21 U.S.C. 321] Definitions; generally

For the purposes of this Act—  2

(a)(1) The term "State", except as used in the last sentence of section 702(a), means any State or Territory of the United States , the District of Columbia , and the Commonwealth of Puerto Rico .

(2) The term "Territory" means any Territory or possession of the United States , including the District of Columbia , and excluding the Commonwealth of Puerto Rico and the Canal Zone.

(b) The term "interstate commerce" means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.

(c) The term "Department" means the Department of Health and Human Services.

(d) The term "Secretary" means the Secretary of Health and Human Services.

(e) The term "person" includes individual, partnership, corporation, and association.

(f) 1 The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.