Terms and Conditions
All American Pharmaceutical (AAP) has served the supplement industry for 30 years with a simple commitment to provide outstanding quality manufacturing and on-time delivery. Our newly remodeled and expanded facility in Billings, Montana reflects this commitment. This commitment is also represented by our compliance with pharmaceutical-level FDA standards. Our facility and manufacturing procedures are third-party certified by Informed-Choice and NSF International.
We specialize in producing private label and custom formulation supplements for almost any market, from general health and sports nutrition, to anti-aging and food products. As a full-service contract manufacturer, we assist our customers from concept development all the way through to finished packaging. At AAP, quality is not about meeting the lowest minimum standard. For us, quality means doing the utmost to ensure that the products we make are authentic, pure, and contaminant-free.
Our Branded Ingredients
AAP offers the following patented and patent pending branded ingredients for use in your formulations:
- Kre-Alkalyn® ..... A pH-correct creatine
- Lyzme5® ..... Weight Loss; cholesterol support
- Kre-Celazine® ..... Promotes joint health
- AminoZorb® ..... Branch chain amino acids
- KarboLyn® ..... Next generation carbohydrate
- Taxadrol® ..... Testosterone booster
- ProtaLyn® ..... The ultimate protein powder
- GlutaZorb® ..... Stable, bioavailable glutamine
Our Commitment to Quality
It is our mission to serve our customers by meeting or exceeding their expectations of us and to build a professional environment that will attract and develop the most talented and qualified staff.
We value our customers, employees, and suppliers as the critical elements to our continued success.
We source and receive raw materials from all around the world. Thus, to ensure we're starting out with the very best ingredients, each batch of material undergoes rigorous scientific testing by our quality control experts.
While most companies only randomly test samples of the raw materials they receive, we test EVERY barrel that comes in...EVERY time. Each material is sampled and quarantined until it is completely tested and approved.
Once all testing is complete and the material(s) approved, each product is issued a Certificate of Analysis. This is a key part of our program to guarantee that our ultra-strict purity, safety, and potency standards will be met.
- FDA registered & inspected facility
- Informed-Choice Certified Manufacturer
- Informed Choice Certified for Sport
- MT DPHHS Food Manufacturing Certificate
- Montana Department of Health
- MMEC GMP Certificate
- USDA Certified facility
- Kosher Certified (Orthodox Union)
- NSF GMP for Sport
- NSF GMP Registered
- ISO 9001 (in progress)
R & D
AAP will create a small sample for client approval of taste, color, and aroma based on best design of client product request.
Any changes to the formula ingredients themselves will require a new R&D project, and charges will be applied.
Specifications & Formula Acceptance
When a Specification Sheet is signed, it means that you authorize approval of the formula for production and purchase of the intended dietary supplement from AAP. Further, you will sign the specification in its entirety and confirm that the product formulation contained in the Specification Sheet is accurate and meets the specifications and suitability for manufacturing and the commercial marketplace. In summary, you are completely responsible for understanding it before signing it. If any adjustments are needed, AAP must be contacted – we will make changes and re-issue the Specification Sheet for you to sign, rendering any other versions invalid.
Since the 2010 final implementation of the Dietary Supplement Health and Education Act, there has been increased scrutiny by the FDA on product labeling to accurately represent formulation. To guarantee compliance, AAP utilizes multiple quality control efforts to ensure that what is stated on our product label is actually contained in the supplement bottle. AAP has invested significant time and labor to validate methodologies suitable for analysis of our products. We are willing to assist you if you would like a third party testing lab analytical evaluation (which must use our matrix-specific validated methodology, provided that a protocol driven method transfer is written and executed to verify that the technology is appropriately transferred to the third-party lab and to provide accurate results prior to evaluation of product). Cost for this method transfer is pending the method.
AAP very much appreciates that you want to verify your product and advise you to consult and acquire an understanding of USP 36 General Chapter 1224 "Transfer of Analytical Procedures" which provides the FDA's current guidance for the proper transfer of method technology between analytical laboratories. AAP has contracted Atlas Biosciences, an ISO 17025 accredited 3rd party laboratory, to assist you with any 3rd party evaluation of anything manufactured by AAP. Method transfer has either been done or will be done for your specific product. Contact your sales representative for a contact and phone number along with details for setting up your testing. In the event you use a third-party lab and test results do not agree with AAP's results, AAP at its cost will send a 3rd party evaluation request out to Atlas Biosciences. AAP will stand behind the results provided by Atlas Biosciences as the approved release factor for your product.
Policy on Cancellation and Changes of Orders
Once the Sales/Customer Service department has entered an order into the AAP system and sends out a copy of the Client Purchase Order with the AAP Order, it cannot be changed or cancelled.
At the time order is entered into our order system, all needed materials are ordered, and the order is set into the schedule for order fulfillment. The Client is responsible for all charges associated with the order. Please ensure you are ready to order and have your Purchase Order correct prior to submitting order to AAP.
Product Production Lead Time
Normal production time for custom made products is 10 weeks, pending receipt of any client labels or other materials. Firm schedule for production cannot be set until such time as client-supplied labels or other items are on site and approved for use. Stock item production lead time is 3 to 30 days pending on item ordered and stock levels.
Method of Shipment
For international shipments the pallet dims are built no higher than 40”x48”x60” for Air and 40”x48”x70” for Sea; either plastic or pressboard pallets are used.
For shipments within the US and Canada the pallets are no higher than 40”x48”x70” and standard wood pallets are used.
AAP is not responsible for damages that occur during shipping. It is your responsibility file a claim for such damages directly to the shipper.
On-Site Laboratory Capabilities
- Full Microbial, including pathogens
- WADA Steroid & Banned Substance Screens
- Heavy Metals Screen Identity Testing
- Herbal Adulteration Testing
- Allergen Screens
- Material Assay/Purity
- Color Analysis
- Particle Size Analysis
Summary of Analytical Chemistry Capabilities
All American Pharmaceutical guarantees the quality, purity, identity, and potency of materials to the Specifications using the following techniques:
AAP's Product Specification sheet contains a "Label Acceptance" section whereby your signature acknowledges and accepts 100% responsibility for product label content, layout, and design as well as marketing claims made on the product label. Product labels must be produced according to the Specification provided; if not, the labels will be refused and returned to you for revision and re-issuance. Costs for producing new labels are your responsibility; additional AAP charges may apply. Additionally, AAP is not responsible for the use of foil labels and we do not recommend their use.
If your labels are to be assembled on rolls, please provide us with AAP's preferred unwind directions: Either #2 (for heat shrink labels) or #4 (for pressure sensitive labels). Refer to the following industry standard label unwind charts for a visual example of AAP's preferred unwind directions. Please note that this requirement does not apply to sleeves.
In many cases the unwind direction is dictated by automatic label applications; however, the label unwind direction can influence many other aspects of the production process.
***Note that there will be a $25.00 rewind charge if the you send in labels that are not in the required configuration.
Label Review Procedure Updates
We take FDA compliance very seriously when it comes to the specifications required for your labels, such as:
1) Supplement/ Nutrition facts, 2) Ingredient listing, and 3) Serving size.
Under our new procedures, items beyond these FDA requirements are now the sole responsibility of the client:
- Label Compliance of Existing Labels: All American is unable to use any label that does not conform to the Food and Drug Administration regulation 21 CFR Part 111.65. Therefore, it is the sole responsibility of the brand/product owner to ensure existing labels are in full compliance with this regulation.
- Spelling/Grammatical Errors: All American does not proof labels for spelling or grammatical errors (except for Supplement/ Nutrition facts, Ingredient listing, and Serving size). Please ensure all spelling and content proofing is completed and signed off by your company prior to sending All American, or before going to print.
- Label Claims: All American will not be responsible and/or liable for any marketing/product function claims made on client labels.
- Receipt of Physical Label: To ensure we stay within your quoted lead time, All American should receive your physical labels within 30 days of placing your order. If labels are received after 30 days, we will add an additional 2 weeks. For each week beyond this, we must add an extra week.
Under this process, All American will perform one review. If a change is needed, we will complete an additional review to ensure the needed changes have been made. If the label information is still not correct, and All American is required to perform subsequent reviews, it is possible additional charges may apply. We will also review the last and final label proof just prior to printing.
We believe these necessary and important updates will help reduce production times so your products can get to market even faster. Additionally, they allow us to remain focused on producing extremely high quality products.
If you or your label designer needs further clarification, please use the FDA reference by clicking here.