Prop 65

Proposition 65

Many California residents are familiar with a law known as Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986 or Prop 65. This law mandates that warnings be given to consumers in various circumstances. California residents see these warnings nearly everywhere — at gas stations, in parking garages, in hotel lobbies and on various consumer products.

The original concept of Prop 65 was to keep chemicals out of drinking water and to warn consumers before they are exposed to chemicals that may cause cancer, birth defects, or other reproductive harm. The California Office of Environmental Health Hazard Assessment (OEHHA) is responsible for publishing this list of chemicals and establishing the exposure levels that require warning statements. There are over 800 chemicals on the Prop 65 list. For example, under Prop 65 an exposure to an amount of lead over 15 micrograms per day requires a cancer warning, while an exposure to an amount of lead over 0.5 micrograms per day would require a reproductive toxicity warning. The level requiring a reproductive toxicity warning is set at a level 1000 times less than the level of exposure where there is no observable effect of harm, a level which is far lower than that set by the EPA or any federal agency. The vast majority of Prop 65 cases involving dietary supplements concern allegations of lead exposure.

WARNING STATEMENTS

When a warning statement is required on a consumer product, including a dietary supplement, it usually reads as follows:

For a carcinogen: WARNING: Cancer — www.P65Warnings.ca.gov

For a reproductive toxin: WARNING: Reproductive Harm — www.P65Warnings.ca.gov

ENFORCEMENT OF PROP 65

Violations of Prop 65 are enforced by the California Attorney General, District Attorneys or by private party “bounty hunters” who are authorized to recover and keep part of the civil penalties recovered through a trial or settlement. As a result of the financial incentive offered to private parties to pursue these cases, lawyers and law firms have become “bounty hunters” and devoted their practices to pursuing settlements and recoveries. In a Prop 65 case, the only allegation is that the company failed to provide a warning – there is no claim that anyone has been harmed by the product at issue. There have been numerous Prop 65 cases and settlements involving dietary supplements.

Most Prop 65 cases settle prior to trial because the company bears the burden of proof to establish that a warning is not required on its products. In 2011, settlements with private party “bounty hunters” totaled over $15 million dollars – of which over $11 million was paid to the lawyers for the “bounty hunters.”

PROBLEMS WITH PROP 65

There have been several critiques leveled against Prop 65. Here are a few:

Prop 65 Unfairly Impacts Natural Products: Products with synthetic ingredients or which are heavily processed can more easily avoid introducing or remove natural contaminants. This unfairly impacts natural products. According to the Alliance for Natural Health, a grass-roots consumer group that seeks to promote health freedom in the United States,

“Some Prop 65 Chemicals are prevalent in the natural environment, and they unavoidably end up in supplements that contain natural ingredients. While there are certain allowable “safe harbor” levels for Prop 65 chemicals in a product, these levels are often either extremely low or must be established through complicated and expensive lab testing at the expense of the supplement company. Prop 65 does provide an exemption for “naturally occurring” chemicals – but it is up to the supplement company to prove that this is the case, which is both very difficult and expensive. In the end, supplement companies have the unfortunate choice of providing a prominent warning on what might in actuality be a very safe supplement, or not provide warning at all and risk noncompliance with Prop 65.” (A Guide to California’s Proposition 65, 2012).

The Prop 65 Bounty Hunter System is Broken: An article by Jim Conran, former director of the California Department of Consumer Affairs, claims that It’s Time to Tame Prop 65 Bounty Hunters, pointing out that what started out as an environmental protection law has turned into a system that mainly seems to enrich private lawyers. A March 2012 law journal article entitled Bounty Hunters and the Public Interest – A Study of Proposition 65 reviews Prop 65 actions and settlements and argues that the law has been abused by private bounty hunters and the California Attorney General should more actively oversee enforcement of the law.
Prop 65 Hurts Small Businesses: The group Citizens Against Lawsuit Abuse believes prop 65 enforcement actions are an abusive practice hurting small businesses.

MORE INFORMATION ON PROP 65

For more information on Prop 65, please see the following links:

https://oehha.ca.gov/proposition-65 – The California Office of Environmental Health Hazard Assessment publishes an overview of Prop 65 on the website. OEHHA also is responsible for publishing the list of Prop 65 chemicals. These lists are available at the foregoing link.

Office of the Attorney General – The Attorney General’s website contains a database of Prop 65 notices of violation and settlements at http://oag.ca.gov/prop65.

Why TheraNeem?

The brands main distinguishing factors are the high concentration of active ingredients, and the quality of neem, used across the product line. Fifty-eight percent of products include two or more forms of neem…including 100% organic neem seed oil (highest standard of organic certification), organic neem leaf tea as the product base and/or the use of concentrated organic supercritical extracts. The advanced supercritical extraction process is known for producing the cleanest, most concentrated, and unaltered complete bouquet of a plants constituents (oils, pigments and resins) in extract form. No other neem-based brand currently offers products which include supercritical extracts.

What is Neem?

Neem oil is rich in fatty acids, such as palmitic, linoleic, and oleic acids, which help support healthy skin. While neem oil is generally applied to the scalp or skin to treat conditions like dandruff and acne, the extract of the neem leaf is typically taken orally. The leaf of the plant also provides health benefits. The leaves contain plant compounds called flavonoids and polyphenols, which have antioxidant, anti-inflammatory, and antibacterial properties.

Are your products available to international customers?

While we do not ship to countries outside of the United States directly through our website, our products are available to international customers on iHerb.com

Is your packaging recyclable?

Yes, most of our packaging is made from paper, plastic and glass that can be recycled.

What are the benefits of Neem?

Hair Care: Neem is known for not only alleviating dryness and itchiness, but also for providing moisture so your hair looks super healthy year-round.

Oral Care: Neem bark and leaf extract is most effectively used fight oral plaque buildup and prevent gingivitis. Mouthwash containing Neem is a remedy for tooth decay and to maintain healthy gums.

Skin Care: Neem oil is filled with ingredients that benefit the skin, like vitamin E and essential fatty acids, which make it a great natural method to fight off dryness. Research has found it can penetrate deeply into the skin, healing the cracks that occur from severe dryness and making sure all your moisture stays locked in. It also has antibacterial properties making it a great acne treatment.

Digestive Health: Neem promotes a healthy digestive system by protecting the stomach, aiding in elimination, and removing toxins and noxious bacteria. Its leaves are often used to treat heartburn and indigestion.

What are Supercritical extracts?

Extracts are substances made by separating raw plant material into concentrated form. Depending upon the plant material used, extracts can be made by a number of processes, including: • Cold-pressing plant material (typically citrus) • Steam distillation • “Supercritical” liquid carbon dioxide (CO2) distillation • Other chemical solvent extraction (i.e. alcohol distillation, etc.) Steam distillation is one of the most common processes used. However, supercritical extracts are becoming more common. They are considered to be potentially superior to traditional steam distillations because the plant material is extracted at much lower temperatures, which may help preserve a fuller range of constituents from the original plant. That’s because the high temperatures required to create steam from water (100 degrees C / 212 degrees F) can potentially damage or destroy some of the constituents in the plant material—thereby altering the material from its original form. Supercritical extraction uses CO2 instead, bringing it to its liquid “supercritical” state at much lower temperatures (90-100 degrees F). That lower processing temperature helps ensure that the final extract contains a fuller spectrum of constituents than are typically derived from steam distillations. CO2 extracts are believed to be closer to the original source material than stream extracts.

How Supercritical extracts are made?

1. Liquid carbon dioxide (CO2) is pumped into an extractor tank containing plant material.

2. Particles of the plant material are suspended in the liquid CO2.

3. The particles are separated from the CO2. The CO2 is returned to the tank.

4. Then the final extract is collected for use. Supercritical extracts are very concentrated. It takes approximately 250 pounds of plant material to create 1 pound of supercritical Neem extract, for example. CO2 extracts are additionally free from organic solvents like hexane, acetone and toluene. The original plant material we use for our supercritical Neem extracts is also organic to help ensure the final extract does not contain chemical pesticide residue, either.

How do you use my data?

We use your data to process and ship your order to your preferred address. If we collect your email address, then we may occasionally send you marketing information about TheraNeem but you are always welcome to opt out of any email by clicking the “Unsubscribe” link at the bottom of our emails. We never sell or share your information with any other company.

What is your return policy?

You may return any item purchased from us for any reason within 30 days of purchase. For online and catalog orders, the product ship date is the date of purchase. Only one opened package of any product in a shipment is eligible for return. All others of the same product must be in unopened and original condition to receive a full refund. Your refund will be processed based on your original form of payment. Opened or damaged items may only be eligible for partial refund or merchandise credit. Shipping and handling charges are non-refundable.

How do I start a return?

To begin your return, please contact our Customer Service Department at customerservice@theraneem.com