Latest News

Kre-Alkalyn® Alert
Sci-Fit Kre-Alkalyn® Products are Counterfeit

All American Pharmaceutical has just become aware that ATF Fitness Products, Inc. is selling a product labeled "Sci-Fit Kre-Alkalyn®” that is counterfeit. These products have been tested and found to contain none to traces of Kre-Alkalyn®, but instead contain creatine monohydrate. The Sci-Fit Kre-Alkalyn® product does not provide the beneficial results of using the patented Kre-Alkalyn® product.  Products identified in this fraud thus far are Sci-Fit Kre-Alklayn® 1500 capsules and Sci-Fit Kre-Alkalyn® 1500 Powder.

Consumers can be confident that they are purchasing an unadulterated Kre-Alkalyn® product by purchasing capsules having a printed and color-coded capsule as displayed below.

Official Purple Kre-Alkalyn® Capsule Guide:

Kre-Alkalyn® Capsule Guide

This alert relates ONLY to the Sci-Fit brand of Kre-Alkalyn® products.

AAP facility expansion complete

All American Pharmaceutical (AAP) recently completed an expansion of its INFORMED-CHOICE* certified manufacturing facility in Billings. The contract manufacturer of nutritional supplements added 33,000 square feet of warehouse storage to its 110,000 square foot, state-of-the-art facility. At the same time, the company's main building was remodeled to the highest FDA standards for a drug-manufacturing facility, including clean rooms for sanitary processing.

"With the additional warehouse space, we're able to free up more space for production," says Joe Archer, VP sales & marketing. "But more importantly, this also gives us room for a separate raw materials warehousing area, which is essential in our ongoing objective to avoid cross-contamination of materials and to be able to quarantine ingredients while testing for authenticity and purity."

With construction complete, AAP expects to hire for new positions in the coming months to staff the addition. "This marks completion of the first phase of our expansion. We expect to begin a second phase next year to add even more production area," comments Archer.

ATF/Sci-Fit License Agreements Cancelled

All American® Pharmaceutical served ATF/Sci-Fit with a Notice Of Cancellation for its license agreements for Kre-Alkalyn®, KarboLyn®, ProtaLyn® and Gluta-Lyn®.

This Notice Of Cancellation means ATF/Sci-Fit will no longer be able to:

  1. Purchase these ingredients/capsules or
  2. Market and sell products with these ingredients/capsules in them.

The Notice Of Cancellation was officially served to ATF/Sci-Fit on Dec. 12, 2011.

AAP featured in Natural Products Insider

Joe Archer, vice president sales and marketing, at All American Pharmaceuticals recently wrote an article "Beyond cGMPs to Contaminant-Free Contract Manufacturing." The article is published online at naturalproductsinsider.com or click here to download a pdf of the article.

AAP qualified as Informed-Choice manufacturer - New certification ensures contaminant free production

All American Pharmaceutical (AAP) announced that its Billings facility received certification as an Informed-Choice manufacturer. The Informed-Choice certification ensures that supplements produced within the AAP facility are manufactured to strict FDA cGMP standards and are regularly tested for prohibited substances in sports—steroids and stimulants—which appear on the World Anti-Doping Agency prohibited substance list. Supplements, produced in AAP’s 110,000 square foot, state-of-the-art facility, are subjected to rigorous quality assurance checks to ensure authenticity, safety, potency and purity.

“As a contract manufacturer of nutritional supplements, we want our customers and our customers’ customers to have complete faith in the quality of our products,” explains Jeff Golini, AAP executive scientist. “We’ve always gone above and beyond minimum standards of quality, and now we have third-party verification of our exacting processes through the Informed-Choice certification.” Nutritional supplement companies need to know that the contract manufacturing facility they are using has appropriate quality controls in place to minimize the risk of cross contamination between ingredients.

Becoming an Informed-Choice certified facility is a three-stage process that begins with a quality audit—and is followed by a preregistration swabbing of the facility to verify that it is contaminant free. The final stage is post-registration swabbing, which is ongoing with regular site visits every six months to ensure continued compliance. “Our goal is zero tolerance for inadvertent contaminants,” says Golini. “The only way to ensure this is through consistent quality measures and regular testing. An added benefit of our Informed-Choice certification is that it streamlines the registration process for our customers to use the Informed-Choice logo on their finished products that we’ve manufactured. The Informed-Choice logo on product packaging gives consumers confidence and lets them know instantly that the product they are buying is what it’s meant to be.”

More information about All American Pharmaceutical's certifcation as an Informed-Choice manufacturer.

 

All American Pharmaceutical begins testing for heavy metals

Why does All American Pharmaceutical (AAP) test for heavy metals? AAP tests for heavy metals because consuming supplements or food with high concentrations of heavy metals can cause acute or chronic poisoning. When consumed in high concentrations, heavy metals are not metabolized by the body and accumulate in the soft tissues. Metal toxicity can happen just above naturally occurring background levels. This poisoning can result in damaged central nervous function, reduced or impaired mental abilities and blood composition damage that can lead to injury in the lungs, liver, kidneys and vital organs. Long-term ingestion of heavy metals will lead to physical, muscular and neurological degenerative conditions, cancer and death.

“AAP tests for heavy metals because we don’t want to sell products that contain them,” explains Jeff Golini, chief scientist at AAP. “Most of toxic heavy metal poisoning is caused by arsenic, cadmium, mercury, lead and inorganic tin. And we guarantee these toxic heavy metals are not present in any product we produce.” [read more]

Market regulations

To safeguard public health, government food agencies in many countries have put in place strict regulations (called directives) that specify maximum concentrations for heavy metals in foods and supplements. In the U.S., the FDA has developed a comprehensive Food Protection Plan that gives acceptable limits of heavy metals. Certain states have legislated further restrictions, like California with its Prop 65.

Other such world directives are:

  • European Commission Directive 1881/2006
  • German Institute for Standardization DIN EN 15765 norm
  • TGA Directive for safety
  • Health Canada Metal Directive

Where do these metals come from?

Heavy metals find their way into our food and supplements via the environment, cross contamination, production equipment and/or deliberate adulteration. Here’s a quick look at the sources of environmental contamination from the most prevalent metals.

Arsenic: High concentrations of arsenic are often found in seafood and items produced from the sea. These organisms absorb and accumulate arsenic from their environment. Consequently any item associated with the sea, usually contains high levels of arsenic. Farmers also use seawater to water their crops, which can also lead to arsenic in herbs, vegetables, rice, etc.

Cadmium: This is found in the soil due to insecticides, fungicides and fertilizers. Plants will absorb this metal from the soil.

Mercury: Most mercury is generated naturally in the environment from volcanic emissions. It is then dispersed throughout the globe by winds and returns to the soil through rain. Pesticides are another source of mercury. Many pesticides sprayed on crops contain a mercury base. This is then absorbed into plant material.

Tin: This usually comes from products being packaged in tin cans. It can also come from the soil.

Metal detection capabilities

AAP has developed a new element screen capable of detecting trace levels down to parts per trillion (ppt.) of the following elements: (lithium, sodium, potassium, rubidium, cesium, beryllium, magnesium, calcium, strontium, barium, scandium, yttrium, lutetium, titanium, zirconium, hafnium, vanadium, niobium, tantalum, chromium, molybdenum, tungsten, manganese, technetium, rhenium, cobalt, rhodium, iridium, nickel, palladium, platinum, copper, silver, gold, zinc, cadmium, mercury, boron, aluminum, gallium, indium, thallium, carbon, silicon, germanium, tin, lead, phosphorus, arsenic, antimony, bismuth, selenium, tellurium, stainless steel, lanthanum, cerium, praseodymium, neodymium, promethium, samarium, europium, gadolinium, terbium, dysprosium, holmium, erbium, thulium, and ytterbium). Stainless steel can also be detected.

A matter of quality

AAP wants to guarantee that all of the products it produces are below global limits for heavy metals content. “This is just another way we can promise that every product that comes down one of our lines is safe,” says Golini. “We are testing every in-bound barrel and all stages of our process. Since our customers’ names and reputations are at stake, they deserve the best from us. This is just a part of being a cGMP manufacturer.”

AAP adds Ultra High Performance Liquid Chromatography as Quality Tool

All American Pharmaceutical (AAP) incorporated a new Accela® high-speed chromatographic system into its quality control measures. The state-of-the-art UHPLC from Thermo Fisher Scientific provides fast, efficient chromatographic separations over an expansive range of flow rates and pressures. This new system is so sensitive and reproducible; it can detect compounds down to 1 ppb. “This enables us to basically find a needle in a haystack,” says Jeff Golini, executive scientist, AAP. “We can quantify raw material or in-process work, detect the smallest amount of a steroid or stimulant, or just plain know what is in every product we make.”

The Accela® system optimizes the performance of sub-two micron particle columns, providing seamless operation spanning conventional LC pressures from short LC columns, up to 15,000 psi for long-column separations of complex bio mixtures. This provides fast, controlled separations with high efficiency and resolution, accelerating LC applications.

Bring in the new

Why did AAP choose the new UHPLC system over the older, more conventional HPLC? ‘Simply put, our customers deserve the best and most cutting-edge, high-tech quality control equipment made,” explains Golini. “Our customer guarantee is, ‘do it right the first time.’ This is just another addition to our QC arsenal, showing customers our ongoing commitment to overall quality and to the FDA’s new cGMPs.”

Kre-Alkalyn® Certified Kosher

The Union of Orthodox Jewish Congregations of America has officially certified Kre-Alkalyn® as a Kosher product. All American Pharmaceutical is now authorized to place the designated Kosher symbol on Kre-Alkalyn® packaging.

All American Pharmaceutical is now enrolling children ages 8 through 14 years of age, with confirmed Juvenile Rheumatoid Arthritis (JRA), in its Juvenile Rheumatoid Arthritis study

This 30 day clinical trial is designed to test the efficacy of Kre-Celazine® in its ability to reduce or eliminate JRA joint and soft tissue inflammation related to the following areas: knee, ankle and foot, as well as shoulder, elbow, wrist, hand. [read more]

The inclusion criteria are:

  1. At least 8 years of age and not more than 14 years of age;
  2. Diagnosed with one of the following types of Juvenile Rheumatoid Arthritis – pauciarticular, polyarticular, or systemic onset;
  3. Experiences joint/soft tissue pain at least 4 out of 7 days each week;
  4. Is a non-diabetic;
  5. Does not smoke;
  6. Does not drink alcohol;
  7. Does not have digestion problems;
  8. Has no known organ failure (i.e., kidney, heart, liver), or cancer;
  9. Is not taking the drug, Methotrexate;
  10. Does not consume more than one 8oz -cup of regular coffee or tea, per day;
  11. Does not currently taking a nutritional supplement for pain;
  12. MUST be able to obtain written permission from their primary care provider to withdraw from all current medication for the duration of the study;

If your child meets the inclusion criteria and is enrolled, you will be required to complete the following:

  • Sign both a Parent Consent for Participation of a Minor, and Legal Waver, forms;
  • Complete a Diagnostic Questionnaire and Data Sheet;
  • Have your child’s blood drawn at your regular clinic/hospital/healthcare center – once at the initiation, and once at the conclusion of the study;
  • Insure that your child takes the assigned number of Kre-Celazine® capsules, each day for 30 conductive days;
  • Assist your child in completing his/her ‘Pain Journal’ weekly;
  • Have your child’s physician re-assess his/her the degree of change in joint/tissue pain/inflammation, at the conclusion of the study;

The project’s assistant, Sandy Bates, will be available for you to communicate with, and can be reached at 406-245-5793 between the hours of 8:00 am and 5:00 pm Monday – Thursday, and 8:00 am and 4:00 pm on Friday for any study-related questions you may have.

Patent Protection

All American defends it’s patent on Kre-Alkalyn and received a default judgment against Mark J. Tallon, Robert Child, CR- Technologies LLP.

It appearing from record that defendant Mark J. Tallon, Having been served with the complaint, and having failed to plead or otherwise defend within the time allowed by law, clerk of court enters the default of defendant, Mark J. Tallon. Dated this 2nd day of October, 2009

Expansion & Growth

High-speed liquid line installed 2008
Capsule Printing equipment installed 2009
Capsule tablet packet machine installed 2009
High speed powder line installed 2010
ICP Equipment Installed
UPLC Equipment Installed

Patents

Kre-Alkalyn®
Kre-Celazine®

Pending Patents

Protalyn®
Karbolyn®
Amino AKG®
Lymze5®

Orphan Drug Applications

Kre-Celazine® filed December 2009 (for the Treatment of Juvenile Rheumatoid Arthritis Joint and Related Tissue Inflammation), in the pediatric population [persons less than age 17].

Grants

Grant received from State of Montana in 2008 for research and commercialization of Kre-Celazine®
Grant received from State of Montana for research and commercialization of Lymze5®