Monday, February 3, 2014

MLM Absurdities: Yes, Your Family Doctor Could Be Selling MLM stuff too

I was reading updates on Tracy Coenan's Sequence Inc. files when I came across a company called Metagenics, which seem to be nutritional supplements sold through doctor's offices (including doctor of chiropractics, i.e. chiropractors).

As most doctors are not nutritionists, one wonders if they are really qualified to do so... or is this just some sort of network marketing that had reached doctor's offices?

You'd think doctors, with proper health education (and I do mean M.D.s, not D.C's  doctor of chiropractics), would know enough to not do something questionable, but there's evidence of even HOSPITALS trying out devices based on pseudo-science.

But it's always possible they know something that we don't. So what can be found by Google?

A quick check revealed that they've been warned by the FDA to stop falsely advertising their product as "good for" (condition), and all there nutritonal supplements, normally classified as "food", had made sufficient claims to be considered DRUGS instead, and that's ILLEGAL!  (Drugs have MUCH more stringent testing criteria).

Here's the first two paragraphs:
English: Logo of the .
English: Logo of the FDA . (Photo credit: Wikipedia)

Dear Dr. Troup:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the internet address in August 2013, and has determined that you take orders there for the products UltraClear®, UltraClear® Plus, UltraClear® Plus pH, UltraClear RENEW™, GI Sustain, UltraMeal® Plus, UltraMeal® Plus 360, UltraInflamX®, UltraInflamX® Plus 360, UltraGlycemX®, GlycemX™ 360, Ultracare for Kids®, BariatrX Essentials Bariatric Meal, and ArginCor. These products are labeled as “medical foods,” and the labeling claims on your website represent these products as medical foods for the dietary management of a variety of medical conditions.

Based on our review, we have determined that these products are misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)(1)], because the labeling is false and misleading in that the products are labeled and marketed as medical foods but do not meet the statutory definition of a medical food in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] or the criteria set forth in 21 CFR 101.9(j)(8). Furthermore, because these products are labeled and marketed as medical foods, but do not meet the statutory definition of a medical food, FDA has determined that these products are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. You can find the Act and its implementing regulations on FDA’s website at
Ouch, this is bad, having your product slapped by no less than the FDA for making irresponsible claims.  But wait, it gets worse:

Quoting from the end of the letter...
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

This letter is not an all-inclusive list of violations in your products and their labeling.  It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for all of your products to ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
While I have not seen the before and after of the Metagenics website, (I guess I can do that with the Wayback Machine...) there seems to be no subsequent letters, so I presumed that they took care of the problems...  I better check on that.

Further research shows that Metagenics is actually owned by Alticor.

Alticor is the parent corporation of Amway.

MLM type Stuff sold in doctor's offices, warned by FDA as falsely labelled.


To be fair to Metagenix, FDA is pretty darn strict on advertising claims. They slapped Lancome USA in 2012 for making advertising claims about "rearrange collagen" and "stimulate youth proteins" with their anti-aging skin treatment. They've also issued warning letters, lots more in recent years, for making overzealous claims that made cosmetics and nutritional supplements sound as if they can 'treat' medical conditions.

But it's STILL not good to be slapped by ANY Federal agency.

And even less good that can cause your affiliates' motivation and qualification to be questioned.

Enhanced by Zemanta


  1. Did you hear?

    1. Mentioned him at least 4 times here on the blog. :)