Forums IMPORTANT: PLEASE READ Beyond Human News Flash the FDA Vs Hypnotherapy and self-Hypnos

Hello I he been made aware that the FAD has this paper and if it goes through then may Affect, the used of personal development media.

I do have a E-mail that as a whole host of information related to this, and how it may effect alternative therapy’s, that I would be happy to post.
http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg335-300.html
Sec. 335.300 Hypnotherapy Devices - Self Hypnotic Tape Recordings (CPG 7124.25)
BACKGROUND:
FDA has both seized self-hypnotic tape recordings and issued regulatory letters to manufacturers concerning such recordings because the intended use of the tapes (gathered from both the tapes and their labeling) made them devices within the *Federal Food, Drug, and Cosmetic Act's* definition of a device. The *center's* position is that the tapes are misbranded because of false *or* misleading medical claims in the accompanying promotional literature. Furthermore, the *center* contends that these tapes are prescription devices and adequate directions for lay use cannot be written for these devices.
Hypnotherapy is a recognized medical modality useful for diagnostic and therapeutic purposes. Tape recordings used in conjunction with hypnotherapy which are intended for use in the mitigation, treatment, and cure of disease and other medical conditions are "devices" as that term is defined in Section 201(h) of the act.
Tape recordings labeled only for behavior modification, self-improvement, habit correction, learning techniques, and simple relaxation are not considered to be devices unless they are also labeled for medical or therapeutic use.
POLICY:
The Agency will not object to the distribution of tape recordings provided the labeling and the text of the recordings do not contain claims for specific disease conditions or therapeutic use. The intended use of the tape recordings as medical devices can be established from the labeling and statements made in the tapes themselves that the tapes have therapeutic and medical usefulness.
Tape recordings, the labeling and text of which claim that the tapes are effective as a form of hypnotherapy (including self-hypnosis) and are intended for use in the mitigation, treatment or cure of a specific disease or medical condition, will be regarded as misbranded devices when sold for lay use.
Examples of objectionable claims for lay use are listed below:
Acne and skin problems
Birth Control
Control of Allergies
Emotional health
Enuresis
Hair loss
Hearing Loss
High blood pressure
Hyperactive children
Improving vision
Insomnia
Menstrual Control
Migraine headaches
Pain Control
Psychic healing
Wart Removal
*The district should consider submitting a recommendation for misbranding to the *Office of Compliance (HFZ-300)* when tapes with such claims are offered for lay use. Refer to Compliance Policy Guide 7150.10, Health Fraud - Factors in Considering Regulatory Action, *(Please Note: The Health Fraud definition includes the "... promotion, advertisement, distribution or sale of articles, intended for human or animal use ...")* for guidance. The appropriate charges are 502(a), in that the labeling is false *or* misleading because the articles are not effective for such use and 502(f)(1) in that the articles fail to bear adequate directions for use since adequate directions for use cannot be written for use by laymen of the articles for the purposes for which the devices are intended and they are not exempt from the requirements of section 502(f)(1) of the act and 21 CFR 801.109.*
For Rx use, district offices should contact the *Office of Compliance (HFZ-300)* for guidance before submitting a recommendation.
*Material between asterisks is new or revised*
Issued: 11/01/81
Revised: 11/21/88, 3/95

http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf

This is a link to the whole FDA paper.

Jay, apparently these are just GUIDELINES for now--but I view it as the camel's nose under the tent. Not good.

What is even more irritating--apparently the FDA can't even regulate what's in their current territory, namely FOOD and DRUGS.

I'm sure many of you are aware of the pet food poisoning from China. So far, it hasn't created much buzz, but the same poisons (melamine primarily) that have been killing pets are now being found in "people" food. If you eat meat, much of the discarded pet food has been fed to hogs.

Even if you don't eat meat, the poisoned wheat and corn gluten seems to have been used for more than just the pet foods. In a recent shipment of wheat gluten destined for "people" food producers, they found a bag of that poison right next to bags of the wheat gluten. It is likely that the wheat gluten in that shipment was "spiked" with the melamine. Apparently adding melamine makes the affected foods appear to have more protein content--thus, brings a better price.

If you eat bread, cereal, pasta, or any number of other things that have wheat gluten, you might be eating this vile stuff.

Here's the worst part. Last week FDA inspectors were denied visas to China, and not permitted to inspect shipments of wheat and corn gluten bound for the US. (Not that the US is the only affected country--South Africa, for one, is reporting wheat and corn gluten tainted with melamine.) Rather than put up a fuss and push the issue, apparently they just meekly backed off.

And this is on top of the e-coli and other contaminations in recent years.

Just amazing, isn't it? You can say, well don't buy anything made in China. Not enough: something classified as an "ingredient" does not have to list the point of origin. Gluten is an ingredient that barely appears on the label.

The FDA needs to keep their cotton-pickers off of "alternative" techniques, and take care of the FOOD and DRUGS. If they can't police the territory they already have, they have no business taking on more.

There is absolutely nothing to worry about here if you read the announcement closely. They are not targeting self-hypnosis products for personal development and self-improvement. They are going after disreputable salesmen who claim self-hypnosis can cure or otherwise treat diseases or physical conditions. Those people discredit this otherwise legitimate field that many of us have benefitted from.

Old news. Read the footer. That's been under the umbrella since 1981 and revised 1988

Quote:

---

*Material between asterisks is new or revised*

Issued: 11/01/81
Revised: 11/21/88, 3/95

---