PurSleep Product Safety

Georgio wrote:As long as it doesn't contain Georgia Peanut Butter I'm OK with it!

Diarrhea of day or more may be from food poisoning
Vast majority of cases unreported, without attention like that of recent peanut scare.
By Mike Stobbe
Associated Press
Posted: Friday, Feb. 20, 2009
More Information
1 in 4 Americans
About 1 in 4 Americans suffer from food poisoning each year.

Associated Press
ATLANTA Next time you have a case of diarrhea that lasts a day or more, chances are better than 1 in 3 that it was food poisoning.

As many as a quarter of Americans suffer a foodborne illness each year – ..........
.....................
Ten years ago, a team of CDC scientists put together the best enduring estimate of how many Americans get food poisoning each year: 76 million illnesses, which resulted in 325,000 hospitalizations and 5,000 deaths.

No more recent figures are available. But the current numbers must be close to 87 million cases, 371,000 hospitalizations and 5,700 deaths each year, according to an Associated Press calculation that used the CDC formula and current population estimates.

The statistics seem even more alarming in the context of a parade of high-profile food-poisoning outbreaks in recent years: salmonella poisoning linked to hot peppers and tomatoes from Mexico that sickened more 1,400 last year; an E. coli outbreak from bagged spinach in 2006; and even deadly cases of hepatitis A from green onions in 2003.

The recent peanut-related salmonella outbreak has caused more than 640 confirmed illnesses in 44 states and been linked to nine deaths. It was traced to a Virginia-based company, Peanut Corp. of America, which makes minor-label peanut butter, peanut paste and other products.

Those numbers just scratch the surface: A case is confirmed only after a lab test is sent to the CDC. Many sick people just soldier on without even seeing a doctor.

Health officials assume that for every salmonella case, there are three dozen unreported cases.

Songbird wrote:

-SWS wrote:rubbers .... that can earn the FDA designation of "food grade."

Just to clarify, -SWS, you DID mean something like "various types or grades of rubber," didn't you?

-SWS wrote:Essential oil grading criteria was also discussed in this post:
viewtopic/t18473/viewtopic.php?p=158416 ... 7b#p158500

The Four Grades of Essential Oils:

Grade A ~ pure therapeutic quality and made from organically grown plants, distilled at correct temperature, time, pressure and harvested at proper season.
Grade B ~ food grade, probably contain synthetics, pesticide, fertilizers, extenders, or carrier oils.
Grade C ~ perfume grade, probably contain same type of adulterating chemicals as food grade oils. Usually contain solvents which are used to gain a higher yield of oil per harvest.
Floral Water ~ a byproduct of the distillation process and is very high quality IF it comes from Grade A distillation process.

There are 4 levels of therapeutic oils:

PURE - This means the oil was not diluted with a lesser quality essential oil.

NATURAL- This means the oil was not adulterated with vegetable oils, propylene glycol, SD Alcohol 40 or other chemicals.

COMPLETE - This means the oil was distilled at low heat & low pressure so that all the therapeutic properties are there. They have not been rectified or purified (which means stripped or redistilled.)

GENUINE or GRADE A - Seeds- not from hybrids, soil- organic soil that never has chemicals put on it. Chemicals are never used on the plants in the field. Distillation by steam at low pressure & low temperature in upright containers & no chemicals are ever used in the process. Must have clarity of definition (one plant could have 200 species.) The time in the distiller is also important- cypress oil needs to be distilled for 24 hours. Many companies will distill at higher temperature for a shorter time. This will destroy the quality of the oil. The distiller must be no more than 50 miles away from the sight where the plants were harvested.

They must have Gas Chromatograph readings with an embossed seal that does not come from their own lab.
Then & only then can they have the words "Grade A" on the label.

SleepGuy wrote:

sleepyhead63 wrote:Are your essential oils grade A , I read somewhere that a label can state its 100% pure essential oil but it also has other ingredients. Grade A is supposed to be the best. Any comments?

I source the EOs from a very large EO supplier with multiple offices throughout the world. They guarantee that all of their oils are 100% pure, undiluted, therapeutic grade and free from pesticides, herbicides, and other artificial chemicals. They have an in-house lab with a Gas Chromotograph that they use to test every batch.

I have not come accross any other grading system so I'm not sure what's meant by "Grade A." That strikes me as something like the FDA grading system for meat and dairy and I'm pretty sure that nothing like that exists for EOs. If it does, I'm confident that these EOs would qualify as being Grade A.

I have another business using EOs and have sourced oils from at least eight other suppliers and have settled in on the very best.

PurSleep wrote:We offer two lines of aromatic oil refills, ten all-natural essential oils and six high-quality cosmetic grade fragrances that we call AirCandy.

ozij wrote:SAG, would you care to supply dates for when the first statement (grade A) and the second statement (two lines) were made?

ozij wrote:Are you sure [gentle concerned compassinate voice accompanied by smileyfaces, rose petals, Care Bears, Celine Dion singing "My Heart Must Go On", etc.] you're not really confused?

ozij wrote:Because when I search, the first quote of Sleep Guy is from Sat Mar 24, 2007 15:55
And the first appearance of Air Candy is from a year later.

ozij wrote:compassinate voice

StillAnotherGuest wrote:

-SWS wrote:Essential oil grading criteria was also discussed in this post:
viewtopic/t18473/viewtopic.php?p=158416 ... 7b#p158500

LOL! It's getting to be that any search on "All Things CPAP" should start with cpaptalk!

-SWS wrote:However, I feel a pretty legitimate question relates to how PurSleep's Essential Oil safety considerations happen to compare/contrast with that of PurSleep's Air Candy line. Bret, do you mind fielding that question in this or perhaps a separate thread? Thanks.

SleepGuy wrote:When it comes to fragrance oils, there is much less information (and apparently less concern) about safety. That said, the FDA regulates all fragrances used in cosmetics (including perfumes, colognes, after shave, lip gloss, lotions, soaps--basically direct dermal contact and inhalation). All of the AirCandy fragrances are labeled by the manufactuer as being FDA approved cosmetic grade.

FDA Authority Over Cosmetics

What does the law say about cosmetic safety and labeling?

The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).

The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act involving product composition--whether they result from ingredients, contaminants, processing, packaging, or shipping and handling--cause cosmetics to be adulterated and subject to regulatory action. Under the FD&C Act, a cosmetic is adulterated if--

"it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual" [with an exception made for hair dyes];
"it consists in whole or in part of any filthy putrid, or decomposed substance";
"it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health";
"its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health"; or
except for hair dyes, "it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)" of the FD&C Act. (FD&C Act, sec. 601)
Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. Under the FD&C Act, a cosmetic is considered misbranded if--

"its labeling is false or misleading in any particular";
its label does not include all required information;
the required information is not adequately prominent and conspicuous;
"its container is so made, formed, or filled as to be misleading";
it is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act; and
"its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970." (FD&C Act, sec. 602)
In addition, under the authority of the FPLA, FDA requires an ingredient declaration to enable consumers to make informed purchasing decisions. Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act.

It is important to understand that Congress passes the laws that govern the United States. To put those laws into effect, Congress authorizes certain government agencies, including FDA, to create and enforce regulations, but only as authorized under the law. A change in FDA's statutory authority over cosmetics would require Congress to change the law.

Does FDA approve cosmetics before they go on the market?
FDA's legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law.

Who is responsible for substantiating the safety of cosmetics?
Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the following warning statement appears conspicuously on the principal display panel of the product's label:

"Warning--The safety of this product has not been determined." (21 CFR 740.10)

In addition, regulations prohibit or restrict the use of several ingredients in cosmetic products and require warning statements on the labels of certain types of cosmetics.

In general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.

Can FDA order the recall of a hazardous cosmetic from the market?
Recalls of cosmetics are voluntary actions taken by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective. FDA categorizes a firm's action as a recall (as opposed to a market withdrawal) when it determines that the product hazard or defect represents a violation of the FD&C Act.

FDA is not authorized to require recalls of cosmetics but does monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA's written request. Recalls are addressed in Title 21 of the Code of Federal Regulations (CFR), sections 7.40 through 7.59.

What actions can FDA take against firms that market adulterated or misbranded cosmetics?
FDA may take regulatory action if it has information to support that a cosmetic is adulterated or misbranded. The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market. To prevent further shipment of an adulterated or misbranded product, the agency may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. Violative cosmetics may be subject to seizure. FDA also may initiate criminal action against a person violating the law.

In addition, FDA works closely with the U.S. Customs Service to monitor imports. Under section 801(a) of the FD&C Act, imported cosmetics are subject to review by FDA at the time of entry through U.S. Customs. Products that do not comply with FDA laws and regulations are subject to refusal of admission into the United States. Violative products must be brought into compliance (if feasible), destroyed, or re-exported.

FDA takes regulatory action based upon agency priorities, consistent with public health concerns and available resources.

Can FDA inspect cosmetic manufacturers?
FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.

Does FDA test cosmetics?
The FD&C Act does not subject cosmetics to FDA premarket approval in order to be marketed legally. However, FDA collects samples for examination and analysis as part of its plant inspections, import inspections, and follow-up to complaints of adverse reactions. FDA may also conduct research on cosmetic products and ingredients to address safety concerns.

The agency does not function as a private testing laboratory, and in order to avoid even the perception of conflict of interest, does not recommend private laboratories to consumers or manufacturers for sample analysis. Testing laboratories are listed in your telephone directory.

Must cosmetic manufacturers register with FDA?
Manufacturers are not required to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries to FDA. However, companies are encouraged to register their establishments and file Cosmetic Product Ingredient Statements with FDA's Voluntary Cosmetic Registration Program (VCRP).

Fragrance Oils and Essential Oils - What's the Difference?
With a growing popular interest in health and wellness, essential oils and aromatherapy make great marketing even when products only have artificially produced scents "inspired" by aromatherapy plant essences. Fragrance oils vs Essential oils. This article explains the difference and the advantages and disadvantages of either.

Have you noticed lately that many household cleaning products and deodorizers are scented with "aromatherapy essentials" or with "Jasmine" or some other exotic fragrance like "Calming"? Do they really add essential oils to dishwashing detergent in quantities significant enough to be of any value and are they therapeutic grade? Well, of course not but with a growing popular interest in health and wellness, essential oils and aromatherapy make great marketing even when products only have artificially produced scents "inspired" by aromatherapy plant essences. Most consumer products use fragrance oils to achieve their scent and although some mimic the scent of well known essential oils they are quite different.

Essential oils are natural and fragrance oils are synthetic

Essential oils are the natural aromatic oils that are extracted from plants. Technically they are not oils at all but complex mixtures of organic compounds that exist within the cells of the plant. Each oil is derived from a single plant source and depending on the species is extracted from the flower petals, leaves, stems, roots, rind of the fruit, seeds, or even the wood of trees. It is likely these compounds have evolved over time to aid the plants in survival by providing resistance to disease or by attracting pollinating insects with their fragrance.

Fragrance oils, sometimes called perfume oils, are man-made organic mixtures that are engineered by chemists to produce an attractive scent. This can be anything from "Lilacs" to "New Car" scent. Although they may contain essential oils as ingredients they will also contain animal and synthetic fixatives, and synthetic compounds derived from petroleum.

Essential oils are therapeutic and fragrance oils are not

Essential oils are not only fragrant but they are also therapeutic and have been used for centuries, medicinally and cosmetically to improve physical and psychological health and well being. They produce specific pharmacological effects through skin absorption and inhalation, which is the very basis of Aromatherapy, a widely used form of natural alternative medicine.

Fragrance oils are used to scent hundreds of consumer products and their sole purpose is to improve the smell of the product. Although they may contain many ingredients, they are biologically less complex than essential oils and provide no therapeutic benefits.

Why do most commercial products use fragrance oils?

With such a profound difference, why do most commercial products use fragrance oils? The main reason is cost but there are issues with supply and the range of scent as well.

The harvesting of plant materials and the production of essential oils can be very costly. Some plants such as lavender are grown on commercial farms and are harvested mechanically. But many are hand picked and in some cases from plants that grow in wild habitat. The yield of oil from the plant material is very small and can range from as much as 10% to as little at 0.02% by weight. The highly prized rose and jasmine essential oils are both derived from hand picked blossoms that yield only 0.02% oil by weight of fresh blossoms. Fragrance oils on the other hand, can be mass produced from relatively inexpensive organic chemicals.

Being crop-based, the supply of plant material and yield of oil will vary from year to year and some plant species have limited habitat. The supply of many essential oils is too limited and unreliable to economically serve the needs of large scale commercial production.

The essential oil industry is analogous to the wine industry. The quality of the final product will vary according to the plant subspecies, the growing conditions and the manufacturing. This variability is not suited to the mass production market.

Only a very tiny percentage of plant species can economically yield usable essential oils and although the range of scent is tremendous, all essential oils have a "natural" fragrance. So if you want to produce the scent of "fresh baked bread" or for that matter "Lily of the Valley", you have to use fragrance oil.

Are there products available that use essential oils?

Yes. Essential oils are the perfect choice for adding fragrance to skin care and bath and body products that are made with natural ingredients. By selecting the right combination of oils, it is possible to achieve a wonderful scent and also enjoy the therapeutic benefits of the oils. The essential oils complement these products. They treat many skin conditions, contribute to healthier skin, relieve aches and pains and have a balancing effect on your mood and sense of well being.

Natural perfumes made exclusively from essential oils can also have a positive effect on your mood. They can reduce anxiety and stress, combat fatigue or be invigorating and stimulating. They tend to be softer than most commercial perfumes produced with synthetic oils. They are not overpowering, and are less likely to irritate you and the people around you.

If you enjoy fragrance, but are sensitive to certain synthetics and chemicals, essential oil fragranced products are a good alternative.

It's your choice.

Knowing the difference between fragrance oils and essential oils is an important first step in deciding which products are best suited to your needs. Mass produced low cost consumer products will use fragrance oils to produce an attractive scent. This is perfectly acceptable for dishwashing detergent but shouldn’t your face cream use pure essential oils? Don’t be fooled by the marketing. Read the labels carefully and make your choice.

SleepGuy wrote:Exactly what do you mean by "inhalation therapy?" I'm confused. My son takes steriods through an inhaler to treat his asthma. He's also had steroids asministered at the hospital through "inhalation therapy." I don't know what that has to do with the PurSlee products (or Vicks, Glade, or any other aromatic product that imparts pleasant smells through natural or artificial aromatics). I suppose they are all "inhalation therapy"?

Inhalation therapy also has a role to play in folk remedies, which vary from effective to useless. For instance, inhalation therapy can be administered at home via a vaporizer or humidifier in your child’s room. Both devices are recognized as effective ways to ease many upper respiratory conditions. In addition, a treatment as basic as inhaling steam from a pot of hot water can provide some relief from congestion-related conditions. When warm moist air is applied to the nose and throat, it begins to thin the mucus and drain the sinuses. It is a fast-acting process, without the bothersome side effects of drowsiness or rebound congestion. (For optimum effects, the user should remain in a warm environment for at least one hour after the inhalation treatment.)

SleepGuy wrote:I don't see much practical different between spashing Aqua-Velva on my face in the morning (and smelling the artificial FOs in it--probably about 30% with 70% perfumers alcohol)

SleepGuy wrote: Because the PurSleep fragrance oils do not contact the body

SleepGuy wrote: it is not necessary to use "cosmetic grade" fragrance oil.

SleepGuy wrote: Even fabric softeners (which are heavily scented) are not cosmetics even though they do come into contact with the body and lungs through extended dermal and inhalation exposure.

SleepGuy wrote: While I have said that all questions are fair about PurSleep products, I am surprised that you don't seem to be applying the same level of scrutiny to other products (like Vics) that would seem to present much more real risk due to the widespread use by children, the petrolatum, and the use of camphor essential oil. The Vics products in particular have been on the market for over 100 years and are intended specifically for "inhalation therapy" all night. You have said nothing of fabric softener products, which are inhaled for many hours a day and absorbed through the skin. It would seem that risks posed by such aromatic produts should also be considered along with the PurSleep products.

SleepGuy wrote:you do not use these products

SleepGuy wrote:though you seem to have a great deal of personal interest in them for whatever reason....

SleepGuy wrote:you seem to have a great deal of personal interest in them for whatever reason....

StillAnotherGuest wrote:Look out, brainstorm! The air intake entrainment idea...

How about using an incense burner (about 25 cents at garage sales) and put a cotton ball in there? A bag of generic cotton balls is like 59 cents, you could change them daily.

Introducing....

SAG-'n-Sleep



Just put a cotton ball with a few drops of EO on it and set the whole thing in front of the air intake.

Counting the 6 bucks for a 10 ml bottle of lavender at Amazon, for 7$ American (64.50$ in Canada) your problems are solved, you have more wicks, more EO, no FDA, no restriction problems.

WearyOne, I'll split the profits.

OK, let's do world hunger next.
SAG

SleepGuy wrote:That said, the FDA regulates all fragrances used in cosmetics (including perfumes, colognes, after shave, lip gloss, lotions, soaps--basically direct dermal contact and inhalation). All of the AirCandy fragrances are labeled by the manufactuer as being FDA approved cosmetic grade.

While the cosmetic industry could use some discipline, the provisions of the FDA Globalization Act do not address the issues most important to remedy the problems in the cosmetic industry: the loop holes that allow fragrance chemicals and "processing aids" to go unlisted on the ingredient lists. According to the rules set in place by the FDA, all ingredients must be listed in order of predominance on a cosmetic ingredient list EXCEPT ingredients that give a product an odor. Because of this loop hole, the word 'fragrance' may represent many hundreds of ingredients in one product. Therefore, a product that contains fragrance chemicals can be labeled 'unscented' or 'fragrance-free'.