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New Chelated Vitamin and Mineral LolliPop Delivers for Kids

CLEVELAND, Sept. 30 /PRNewswire/ -- Kangaroo Kids NutraPops(R) are being introduced to U.S. food, mass and drug stores this fall as the newest and safest alternative for children's vitamin and mineral supplement support.

Earlier this summer, "The Journal of the American Medical Association" reversed its 20-year stand on daily vitamin and mineral supplement importance from not necessary to take "one-a-day."

Now a friendly and convenient innovation delivers essential nutrients as prescribed by U.S. RDA guidelines in a safe, friendly and convenient form, the Lollipop.

Vitamin and mineral supplements are required to support children's overall health and well being. Children's consumption of vitamins and minerals is now, more so than ever, being endorsed and supported by pediatrician recommendations for child development.

Parents polled desire to be proactive and "good responsible parents." Vitamins are viewed by parents as a form of prevention, reducing the likelihood and severity of illness. Most parents agree that time and lifestyle constraints stress family health and wellness. Innovative, affordable wellness enhancing alternatives provide solutions and relief for parents who want to support their children's overall health and nutrition.

Marketing efforts are being targeted at parents and pediatricians with safety, efficacy and child compliance as the key benefits. Improvita Health Products Inc. (Cleveland, Ohio) manufactures and distributes children and adult wellness and symptoms relief products such as Runny Rhino Cold Relief Pops(R), Gassy Gator Tummy Pops(R) and Kangaroo Kids Nutra Pops(R).

SFA Endorses FDA Acrylamide Action Plan

Alexandria, Va. - The Snack Food Association (SFA) issued the following statement commenting on the Food and Drug Administration’s (FDA) action plan to assess the presence of acrylamide in the US food supply.

“The snack food industry strongly supports the FDA’s comprehensive action plan. The FDA is asking the right questions about how much acrylamide is in a broad range of foods that are processed at high temperatures. The FDA is asking the right toxicological questions about how the body metabolizes acrylamide and how toxic it may or may not be. And, FDA is moving to determine whether any additional steps are necessary, ” said Jim McCarthy, President and CEO of SFA.

The Snack Food Association is an international trade association of more than 700 member companies that represent snack manufacturers and suppliers to the snack industry. Snacks produced and sold by SFA members include potato chips, tortilla chips, corn chips, pretzels, popcorn, crackers, extruded snacks, meat snacks, pork rinds, snack nuts, party mix and other snacks.

CPB to Offer Neptune Technologies & Bioressources, Inc.'s Krill and Other Marine Products

Under the provisions set forth in the Dietary Supplement Health and Education Act (DSHEA), Neptune Technologies & Bioressources, Inc., has met the mandated 75 day safety substantiation rule prior to sale of its products. These products include NEPTUNE KRILL OIL™ (NKO™), NEPTUNE KRILL AQUATEIN™ (NKA™) and NEPTUNE LYO-KRILL™ (NLK™).

Ongoing clinical trials are exhibiting promising benefits in the area of reducing cholesterol and minimizing the symptoms of PMS, as seen in published interim reports. (Copies available from CPB) Additional clinical studies in other health related areas will be available in the coming weeks.

Neptune Technologies & Bioressources, Inc., exploits its patent pending extraction process for marine biomasses such as Krill and other marine resources, offering its products to the nutraceutical, cosmetic, cosmeceutical and biopharmaceutical markets.

Neptune’s exclusive sales agent, CPB International, Inc., located in Newfoundland, New Jersey is accepting orders for shipments and can be reached at 973-208-6288.

California Governor Davis Signs Legislation to Label Dietary Supplements Linked to Deaths

SACRAMENTO, CA -- Governor Gray Davis has signed two bills to require label warnings on products containing the herbal dietary supplement ephedra, which have been linked to as many as 54 deaths across the nation.

SB 1884 by Sen. Jackie Speier (D-Hillsborough) requires that labels of dietary supplements containing ephedrine display specific warnings and the toll-free number for consumers to report adverse reactions of the U.S. Food and Drug Administration's (FDA) adverse events reporting program and would prohibit the sale of these products to individuals under 18 years old.

SB 1948 by Sen. Liz Figueroa (D-Fremont), a companion bill to SB 1884, will require warning labels on dietary supplements to be clear and conspicuous.

"I vetoed a similar bill two years ago citing the need for federal regulatory action. It was my expectation that the federal government would take a more aggressive regulatory approach toward this substance," said Gov. Davis. "While regulation of dietary supplements and interstate commerce is the responsibility of the federal government, Californians can't wait for federal action that is too long overdue."

In June, U.S. Dept. of Health and Human Services Secretary Tommy Thompson ordered a review of reports on the adverse effects of ephedra. On August 16, 2002, Gov. Davis directed California Department of Health Services Director Dr. Diana Bonta, to send a letter to the FDA requesting aggressive action to regulate the sale or inform the public of the possible health risks associated with products containing ephedra.

The federal government has failed to act, leading Gov. Davis to sign the two bills.

To the Members of the California Legislature:

I am signing Senate Bill 1884. SB 1884 would require that labels of dietary supplements containing ephedrine alkaloids or steroid hormone precursors list the quantity of ephedrine alkaloids from herbal abstracts, specific warnings, and the federal Food and Drug Administration’s Medwatch number, and would prohibit sales of these supplements to minors.

I vetoed a similar bill two years ago citing the need for federal regulatory action. It was my expectation that the federal government would take a more aggressive regulatory approach toward this substance. Ephedra has been linked to adverse health effects and, according to the New England Journal of Medicine, at least 54 deaths. SB 1884 would protect minors from the health risks of dietary supplements containing ephedrine alkaloids and would provide consumers with a reliable resource for reporting adverse reactions.

In June, United States Department of Health and Human Services Secretary Tommy Thompson ordered a review of reports on the adverse effects of ephedra. Because of this inadequate response on the part of the federal government, on August 16, 2002, I directed the State Director of the Department Health Services to send a letter to the FDA requesting aggressive action to regulate the sale or inform the public of the possible health risks associated with this product. They have declined to do so.

While regulation of dietary supplements and interstate commerce is the responsibility of the Federal government, Californians can’t wait forever for federal action that is already long overdue.

In signing this legislation, I am also relying on a letter from Senator Speier dated September 18, 2002, which further explains that the bill does not affect the definition of "anabolic steroids" as that term is used in the Civil Code law or under any other provision of state law.



Stiff, Sore Muscles? Neck Pain?

Ottawa, Ontario (August 21, 2002) Canadian-based Green Sleep announced today the introduction of a new line to its current offerings of natural, organic bedding products: Saguenay 9000 Organic Cherry Pit Cushions. Filled with organic cherry pits from Poland and covered with organic cotton velour, the cushions can be used for both hot and cold therapies for swollen, tense muscles and forehead headaches. “The use of the cherry pit cushion began in Switzerland several centuries ago where the cherry pit was used as both a medicinal treatment and a relaxation, heating cushion,” says Jean Corriveau, President of Green Sleep. By placing the cushion in a microwave or conventional oven for heat and a freezer for cold therapy, the cherry pit quickly absorbs the heat or cold and releases it very slowly – creating a comfortable, safe and long lasting experience for the user. The cushion holds its temperature for up to 1 hour and can be placed directly against the body. “When it comes to heat therapy, our product maintains a temperature that is superior to the traditional hot water bottle,” adds Jean.

Handcrafted in six delightful styles, consumers can choose from a dolphin, bear, rabbit, square bag, bar or cervical cushion. Machine washable and easy to care for, the cushions do not contain any chemicals or synthetic elements and can be used safely by those who have chemical or environmental sensitivities. The organic cotton is cultivated and handpicked in the traditional cooperative manner in the Peruvian Andes and is certified organic by Europe’s oldest and most prestigious certification agency, KRAV of Sweden. Cushions range from $19 to $29 retail.

The company suggests many uses for these cushions including:

  • Sports injuries
  • Cramping and low back pain associated with a woman’s cycle
  • Comfort for pregnant women by relaxing the lumbar region
  • As a replacement for a wet face cloth in childbirth
  • The ultimate bed warmer on a cold night!,/ul>

    The Saguenay 9000 Cherry Pit Cushions are available by calling Green Sleep at 888.413.4442. For more information about Green Sleep and its natural bedding products and mattresses, please see

    Jean Corriveau is available for an interview or comment by calling 888.413.4442.

The Essential Technical & Regulatory E-News Sept, 2002

New Substances

CMEC has recommended that the following is suitable for use as an active ingredient in listable therapeutic goods: Magnesium phosphate dibasic trihydrate


TGA News

CMEC Recommendations – Meeting 35 & 36 – expanded notes

Red Yeast Rice was previously not recommended for listing due to safety reasons. Committee members noted that not all extracts of red yeast rice were evaluated - the substance evaluated was a specific extract, prepared in a non-traditional manner, and it contained a higher level of lovastatin than would be expected in a traditional preparation. Members agreed that the minutes of meeting 34 should be changed to indicate that the decision did not relate to all red yeast rice substances.

Both Chlorella pyrenoidosa and Spirulina maxima are currently eligible for inclusion in listed complementary medicines only as non-active (excipient) ingredients. The TGA Office of Complementary Medicines has recommended that, subject to further discussion, these two ingredients be eligible for inclusion as active ingredients in listed medicines.

Medical Device Regulatory Change

Recent amendments to the Therapeutic Goods Regulations included changes relating to devices of human or animal origin. The insertion of “bacterial or recombinant origin” ensures all biological devices included in this clause require evaluation for both safety and efficacy. The change affects listable medical device products incorporating bacterial or recombinant substances.

Current Status of Australian codes of GMP

The TGA has set out the various manufacturing standards, specified in the Therapeutic Goods Act 1989 as Manufacturing Principles, for different categories of therapeutic goods regulated by TGA effective August 2002.

Compositional Guidelines

The TGA has prepared compositional guidelines (CG) for the following ingredients in complementary medicines (follow link to TGA web page):

More information at

GMP For Starting Materials

Therapeutic Goods Manufacturing Principles Determination 2 available at:

New Code of GMP Seminar Notes

If you were unable to make the August GMP seminars – notes are available to download at

The new Australian Code of GMP for Medicinal Products can be downloaded from

Enterprise Details Form Replaced

A new “Client Details Form” has been introduced to replace the “Enterprise Details Form”. This should be completed by or for each sponsor involved with the supply of the therapeutic goods in Australia. All clients of Robert Forbes & Associates will receive a partly completed form from us, no need to download from TGA.



On 17th September the following products were issued Class II Recalls due to the recovery of “wrongly supplied” goods pursuant to Section 30 Therapeutic Goods Act 1989:

Kava 1800 Plus tablets (Eagle Pharmaceuticals)

Passionflower 220 Plus tablets (Eagle Pharmaceuticals)

Calmo Drops (Eagle Pharmaceuticals)

The issue with the above is that the products were labelled as containing as an active ingredient, the herb skullcap. However, testing by the TGA Laboratories revealed that the ingredient contained was not skullcap (Scutellaria lateriflora). This problem was identified during investigations into the death of an Australian person taking a product containing kava kava.

On 17th September the following product was issued a Class II Recall due to the possible microbial contamination in some bottles: Difflam C Alcohol Free Solution, 100mL (3M Pharmaceuticals Pty Ltd)

[Class I defects are potentially life-threatening or could cause a serious risk to health. Class II defects could cause illness or mistreatment, but are not Class I. Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.]

Kava Update

Last month the TGA issued a voluntary recall of all complementary medicines containing the herb kava. The recall was in response to a fatal adverse event in a 56 year old woman. The Kava medicine implicated in this event also claimed to contain Passiflora incarnata (passion flower), and Scutellaria lateriflora (skullcap). Testing by TGA has confirmed the presence of kava and Passiflora, but Scutellaria lateriflora was not detected. To date, the identity of the third ingredient has not been established. The TGA continues to investigate this apparent breakdown in GMP and QA procedures.


Trans Tasman - New Inquiry Agreed

The New Zealand Government Health Select Committee’s Chairwoman, Steve Chadwick, has announced an inquiry into the establishment of a Trans Tasman agency to regulate therapeutic products. Mrs Chadwick said that community concerns had led to the decision for the inquiry.


New Food Standards Become Mandatory on 20 December

The Australia New Zealand Food Standards Code comes into force as the only food standards for Australia and New Zealand on 20th December. This date will also see the repeal of the old Australian Food Standards Code and the New Zealand Food Regulations. All food produced in both countries from that date must comply with the new Standards. The new code introduces:

§ Mandatory nutrition labelling, with few exemptions.

§ Mandatary labelling of certain foods and additives that are recognised to cause severe adverse reactions in some people, even where the food is exempt from ingredient labelling.

§ Percentage labelling of characterising ingredient or components, for example the amount of cocoa solids in chocolate

Other labelling requirements remain essentially the same as in the old Australian Food Standards Code and New Zealand Food Regulations. This ends the two year period where the old and new Standards have been running in parallel and in New Zealand both these plus the Food Regulations have been alternatives for food manufacturers and importers. Transitional arrangements allow food produced before 20th December and compliant with one of the repealed laws to be sold for a period of up to 2 years for products with a shelf-life of one year or more, and up to one year for products with a shelf-life of less than one year.

The new standards can be found at A reliable update service on paper and on CD is available from Food Liaison Pty Ltd:


Australian Natural Therapy Industry Study

The Sydney Morning Herald (17.09.02), reported on a recent study by Dr MacLennan published in the Preventative Medicine Journal. The study was conducted by Adelaide University and showed 60% of women and 44% of men now use alternative therapies. The report stated that Australians spend four times more on alternative therapies than they do on pharmaceuticals. In total it was estimated that Australians spent $2.3 billion on alternative medicine and therapies in 2000, more than twice what was spent in 1993.

It found alternative medicine users were more likely to be female, Australian born, of higher socio-economic status, better educated, single and employed. They were less likely to have diabetes, high blood pressure or cholesterol levels.


Amendments to Therapeutic Goods Advertising Code

Amendments to the code include the following clarifications:

· who is the “sponsor” of research

· meaning of “prohibited representation” and addition of HCV (hepatitis C virus) to the list of prohibitions

· clarity/size/readability etc of warning statements

· weight management claims must include reference to lifestyle changes such as diet and exercise

· some appeal processes

· acne preparations and unscheduled anti-dandruff preparations added to the list of goods that may be advertised to minors

Full details at


Conferences and Meetings 2002

National Herbal Medicine Week

September 16 – 22 Contact mailto:[email protected] for further details

First Asia Conference on Dietary Supplements (IADSA)

September 24-25, Bangkok,Thailand

Natural Healthcare Conference 2002

September 28 – 30, Sydney Convention& Exhibition Centre, Darling Harbour, Sydney, Contact – Event Managers phone –(02) 9299 9673

Natural Healthcare Expo 2002 (previously named CHC Expo)

September 29 – 30, Sydney Convention& Exhibition Centre, Darling Harbour, Sydney; Phone – (02) 9290 1234 or (03)95302500

Adoption of PIC/S GMP Guidelines Workshop

1 – 2 October, Holiday Inn, Potts Point, Sydney; Register online at or phone the CHC on 02 6260 4122 for further details

Importing/Exporting Restricted Substances (TGA Information Seminar)

2 October 2002, Edmund Barton Building, Barton ACT; Ms Sharyn McGregor, Phone 02 6270 4384, Email [email protected]

Pharmacy Australia Congress 2002, Hobart

October 18 – 20, Wrest Point,Hobart, Tas Contact (03) 9903 9585 or

NHAA Women in Health Seminar

Seminar includes information on HRT, endometriosis, herbal medicines for menopause, and the oral contraceptive pill – safety and herbal interactions. October 19 – Sydney; Contact mailto:[email protected] or phone (02) 95607077

New Code of GMP – seminars

Late October, Perth, Diana Barron ([email protected])

Evidence based Herbal Medicines: >From tradition to clinic

6th HMREC Annual Symposium (Herbal Medicines Research & education Center – University of Sydney) - 1 November, 12.30 – 6.30pm

Pharmacovigilance - the Study of Adverse Drug Reactions

4 – 15 November, Canberra

The Natural Health Fair 2002

November 13-15, Hong Kong Convention&Exhibition Centre; Asia’s International trade event.

Pharmaceutical Science Beyond the Genome: Harnessing the Potential

8 – 11 December, Carlton Crest Hotel, Melbourne;


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Regulatory Affairs & GMP Consultants

Phone: 61 2 96608027 - Fax:612 96608106

Postal: PO Box 123, Annandale NSW 2038 Australia

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Copyright © 2002Robert Forbes & Associates Pty Ltd. All rights reserved.

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Editorial: Talking Economics

By Len Monheit

It’s a dry subject. It takes meticulous research and attention to details. It demands a big picture approach. It’s mostly about numbers. It’s certainly not an approach for everyone.

An economic rationale for supplementation and fortification--

-The development and presentation of economic arguments to drive the complementary medicines sector and to reinforce the need for a dietary supplementation strategy.

HMO’s have successfully used the argument to gain coverage for complementary medical care.

The question obviously is, “How does the argument get taken to a higher, economic level?”

And with the recent reversal of the AMA (American Medical Association) in its position regarding vitamin and mineral supplementation and endorsing supplementation to shore up inadequate dietary levels, you would think that the economic argument of health cost containment would be used more frequently by industry associations and groups seeking to establish and strengthen the role of dietary supplementation and complementary medicine. Although the thin edge of the wedge would obviously be vitamins, the argument would presumably extend to other products and services that would reduce strain and cost on bulging health care systems, and would have a preventative or prophylactic approach rather than a reactive one, (which many would argue makes economic and efficiency sense) Groups would then be able to speak about and reinforce effective programs such as the Healthy Foundation’s Vitamin Relief USA presenting at-risk populations with opportunities for nutritional supplementation.

This approach is different from the traditional lobbying of government representatives and agencies. At a conference this past week, a lobby expert acknowledged the merits of the economic approach, and went on to explain why he held little confidence that government would be moved by traditional approaches despite strong scientific evidence supporting many products, as well as the support of associations such as the AMA. When pressed for reasons why the argument is not more frequently used, this person was at a loss and speculated that it was difficult to get to a big enough picture or view, where the economic impact could be analyzed.

The question obviously is, “How does the argument get taken to a higher, economic level?” Will the numbers support the theory that supplementation, fortification, complementary medicine and therapies will reduce health care costs, improve productivity and improve standard of life?

Unfortunately, economic argument, by definition, is certainly not an emotional one, and so gaining support, advocates and endorsement is more challenging. As well, the issue supercedes specific companies and products and so must be managed from a broad base.

I’ve spoken frequently with industry colleagues who maintain that talking to the business community--about employee absences, the cost of benefit administration, rising health cost burden in general and approaching insurance companies and other stakeholders at this level would be a useful industry exercise. And at another level, a healthier workforce obviously is a more productive one, and productivity has been a serious concern for international competitiveness, so it would seem that a compelling business case could be included in discussions about supplementation and food and beverage fortification.

I know I’m not the only one struck by the logic of the argument. I’d certainly be interested in hearing from others, perhaps even those who have used it—successfully or not.

Let's hear your comments in the NPIcenter Discussion Forums

UK Government to Recognize Ayurveda Medicine

According to a government press release Wednesday, the Indian Systems of Medicine and Homeopathy (ISM and H) has successfully influenced the UK government to accept the scientific base of Ayurveda Medicine and recognize ayurveda BAMS (the Bachelor degree in the field) course and allow institutionally qualified physicians to practice in the UK.

The UK government's Department of Health set up an Herbal Medicines Regulatory Working Group (HMRWG) to work out the details of curricula and a possible frame work to regulate drugs and practice in herbal medicines including ayurveda. The curriculum for BAMS course and Indian Medicine Central Council (IMCC) Act 1970 which regulates education and practice in ayurveda has been sent to British authorities to assist in developing the UK curriculum and regulatory frame work.

AHCC® Study Published in Journal Of Hepatology

AHCC Intake Can Improve Prognosis For Postoperative Hepatocellular Carcinoma Patients

RYE, New York ‹ A nine-year study conducted on 269 post-operative liver-cancer patients using AHCC® (Active Hexose Correlated Compound) was recently published in the Journal of Hepatology (2002;37:78-86)-- The Official Journal of the European Association for the Study of Liver. The study demonstrated a significant and positive influence on immune function, concluding that AHCC can improve the prognosis for postoperative hepatocellular carcinoma (HCC) patients.

In vitro experiments have shown that AHCC enhances natural killer cell activity, and may be considered a potent biological response modifier in the treatment of cancer patients. A prospective cohort study was performed from February 1, 1992 to December 31, 2001. A total of 269 consecutive patients with histologically confirmed HCC were studied. The study examined ten different parameters related to liver function after surgery.

Of the 269 patients, 113 received AHCC orally after undergoing curative surgery. Researchers at the University of Osaka, Japan, concluded that, compared with the control group, the AHCC group had a significantly longer period with no disease recurrence, a higher survival rate, and an increased overall survival rate.

AHCC is derived from a highly specialized manufacturing process developed in the mid-1980s that relies on the hybridization of several species of mushrooms cultivated in Japan. According to industry analysts in Japan, over 700 hospitals and medical clinics recommend AHCC to patients in that country as part of an immune enhancement maintenance regimen, creating a $150 million (USD) industry.

AHCC has been the subject of numerous clinical studies conducted at prestigious Japanese institutions such as Hokkaido University, Kyorin University and Teikyo University. Currently 40,000 individuals worldwide use the nutritional supplement monthly.

The abstract of the study can be viewed at

I f you are interested in receiving a copy of the full text edition, contact Tiia Sumera at 801.538.0777 ext.112 or [email protected] For more information on AHCC®, visit

Nurture, Inc. Introduces Oat Bran Concentrate that Meets the Criteria for the FDA Heart Health Claim

DEVON, PA,— Nurture, Inc. today introduced OatVantage™, an oat-based ingredient that may enable manufacturers to make an FDA heart health claim on their foods, beverages and supplements. OatVantage™ is a highly concentrated soluble oat fiber that provides a cholesterol-reducing benefit at a more convenient dose level than previously possible.

OatVantage is oat bran concentrate that contains 50% beta-glucan by weight — the highest level of concentration available,” said H. Griffith Parker, Chairman of Nurture. “This high concentration enables just 1.5 grams of OatVantage to economically deliver 0.75 grams of beta-glucan, a soluble fiber. Products that contain 0.75 grams of beta-glucan may qualify for use of the following FDA model health claim: “Soluble fiber from foods such as oats, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.” The amount of beta-glucan soluble fiber needed daily for an effect on cholesterol is about 3 grams.

Soluble fiber, specifically beta-glucan, is the primary agent in oats believed to contribute to the reduction of total serum and LDL cholesterol, high blood pressure, and the moderation of glycemic response in diabetics.

“The cardiovascular benefits of oat soluble fiber, including cholesterol-lowering effects, are supported by a number of published studies,” said Gary Fulcher, Ph.D., Professor, Department of Food Science and Nutrition, University of Minnesota.

“There is high awareness of the link between oats and a healthy heart,” reports Parker. “Our research shows that nearly 30% of consumers want to see ‘oats’ on the label. Oats are a natural ingredient, familiar to most American consumers.” An all-natural food ingredient, OatVantage is derived from non-GMO oats manufactured in a GMP-approved facility. OatVantage is available as a free-flowing powder that is water-soluble and has a neutral taste. It can be used in capsules, tablets, opaque liquids, semi-solid foods and other applications.

“OatVantage is the result of a three-year technology development venture with General Mills”, added Parker. “The patented concentrating technology that resulted from this venture enables a product containing five times greater concentration of beta-glucan than is normally found in oat bran. It also enables applications in dietary supplements, foods, and beverages that were not previously possible due to formulation issues.”

Nurture, Inc. has developed a proprietary extraction process for producing the highest level of concentrated oat beta glucan commercially available to the Nutrition & Health market. The company is focused on developing its extraction technology to produce additional soluble oat bran fiber products. For further information about OatVantage, please call (610) 989-0945.

Nurture, Inc. is a leading developer, manufacturer, and marketer of proprietary, high value-added ingredients derived from oats for use in human health and personal care applications. Products include OatVantageÔ, Refined Oat Oil and Ultra Fine Oat Protein. All Nurture products are developed to benefit specific health needs such as cardiovascular health, diabetes and weight management. Founded in 1992, Nurture’s

Contact: Gregory J. Stephens, RD
Vice President, Sales & Marketing
Nurture, Inc.