Maxam Nutraceutics shut down by FDA
The supplement company Maxam Nutraceutics was shut down by the FDA and United States District Judge Michael H. Simon on Thursday, February 5. Maxam made PCA, an oral clathration spray which some parents say helped counter the effects of autism and Aspergers in their children (Some have said it didn't work too). I take it and it makes me feel more alert and awake, but I've heard it has a much more noticeable effect on young children.
Clathration, used to remove heavy metals and other toxins from the body, is a safer alternative to chelation.
I have mixed feelings about this. Maxam broke the law by claiming its products cured specific conditions. This was unfair to the vast majority of other supplement companies, which don't make such claims. The FDA also said it found unsanitary conditions at Maxam's factory (which looks to me like the kind of charge that could be made against a lot of companies if the FDA looked hard enough).
Although I understand the government's position, it doesn't seem to have considered the effect this will have on Maxam's customers, whose conditions will worsen without Maxam's supplements.
On the other hand, maybe another, more law abiding company will come along and develop products similar to Maxam's, making them available again.
This is old news. Maxam was falsely and illegally claiming that their products were cures.
Furthermore, your above-listed products are offered for conditions which are not amendable to self-diagnoses and treatment by individuals who are not medical practitioners such as, but not limited to, autism, Alzheimer's disease, heavy metal toxicity, uterine fibroids, mood disorders, impotence, asthma, diabetes, and infections including herpes, HIV (human immunodeficiency virus), and EBV (Epstein-Barr virus). Therefore, adequate directions cannot be written so that laymen can use your products safely for their intended uses. Thus, the labeling of your above-listed products fail to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). The above~listed products are not exempt, under 21 C.F.R. §§ 201.100(c)(2) and 201.115, from the requirement that their labeling bear adequate directions for use because they lack approved applications. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act, 21 U.S.C. § 331(a).
It does not matter how much anecdotal 'evidence' for the alleged efficacy of a phony 'cure' there might be, simply because the plural of 'anecdote' is not 'evidence'.
Reference: http://www.fda.gov/ICECI/EnforcementAct ... 229184.htm
The reviews of PCA have been overwhelmingly positive, and the charges originated with a disgruntled former employee, not because of any customer complaints. Safety is not an issue here since no one has been adversely affected by Maxam's products. As for the labeling and directions issue, the directions for PCA say to spray it under your tongue and wait a couple minutes. The FDA accused Maxam of not instructing its customers to swallow it afterward, but people could figure that part out on their own.
Although the supplements weren't marketed correctly, there was no problem with the products themselves.
I agree they broke the law, as I have stated from the beginning of this thread. Because of their poor business and legal skills they can no longer supply a supplement that helps alleviate the symptoms of autism and Aspergers. It will be a long time before a similar product becomes available from a drug company, if ever.
I also share your suspicion that their claims might have been exaggerated. For that to happen, there would have first had to be something to exaggerate upon, meaning that even if the product doesn't do as much good as they say, it still does some good.
On second thought, given the results I've had from PCA, I doubt their claims were exaggerated. It's a case of good science marred by sloppy business skills and arrogance. Maxam didn't claim its products could cure illnesses, only treat them. That's not such a big claim.
But I'm still disappointed in Maxam. I don't see probiotics manufacturers claiming probiotics can be used to treat Aspergers, even though they can (I have experienced this firsthand). I don't see vitamin C companies claiming vitamin C can be used to treat a cold. Both those products sell plenty well without their manufacturers having to make such claims.
The lesson here, one I've heard repeated countless times, is that it's not enough to be a good entrepreneur. The entrepreneur needs competent lawyers, MBAs, marketers, etc.