| Supplement manufacturing is a $20 billion industry | | | | formulas with multiple ingredients. |
| in the United States. This industry is a growing | | | | Substitution of Cheaper Compounds |
| lucrative prospect. Because the cost of setting up | | | | Stringent manufacturing practices are useless if |
| a manufacturing unit is expensive, many clients | | | | the nutrients cannot be easily absorbed by the |
| prefer to use the expert services of a | | | | body. Some supplement manufacturers may |
| supplement manufacturer. However, before | | | | substitute cheaper compounds. A client should |
| jumping on to the bandwagon, consider the | | | | make sure that more absorbable compounds are |
| challenges that might be encountered from a | | | | being used rather than the less absorbable ones. |
| supplement manufacturer.Supplement | | | | For example, many calcium formulas include |
| manufacturers and their clients need to work | | | | magnesium; well-absorbed forms include |
| closely together in the production of health | | | | magnesium aspartate, magnesium glycinate and |
| supplements that are viable in today's market, | | | | magnesium oxide. Many other minerals may be |
| reflecting the needs of the community and most | | | | complex as aspartates or picolinates, which |
| importantly-a quality nutrient that is consistently | | | | generally provide excellent absorption. |
| dependable and reliable. Hence, one of the most | | | | Additives also effect the absorption of nutrients |
| challenging areas is a manufacturer who gives | | | | by the body. Additives are used by all |
| utmost priority to quality control. | | | | manufacturers use in the production of |
| Poor Quality Control | | | | supplements. These additives have a number of |
| Dissolution failure, sub-potency, super-potency, | | | | effects, including decreased absorption. In a study |
| mis-labeling and a number of other problems | | | | published in Pharmaceutical Technology, the |
| continue to plague nutraceutical companies.Unlike | | | | percent dissolution for capsules after 20 minutes |
| synthesized products, quality control poses unique | | | | in solution went from 90% without stearates to |
| challenges for a natural product. Often, without | | | | 25% with stearates. These substances clearly |
| extensive method development and research, it is | | | | affect the dissolution and rapid absorption of |
| not possible to verify the marker compound | | | | nutrients.Problems with supplements can render |
| levels against the label claim (i.e. Supplement Facts | | | | them useless and in some cases even dangerous. |
| Label). This is especially true when the compounds | | | | Clients should have access to an experienced |
| found in two or more of the botanicals are in the | | | | R&D team for expertise in manufacturing and |
| same class. When a product contains a blend of | | | | formulation, and in nutrient selection. |
| 10 botanicals that are not standardized extracts it | | | | Inadequate Facility |
| is even more difficult. | | | | An inadequately equipped facility could pose a |
| Also, many botanical constituents will bind to | | | | challenge. The supplement manufacturer is often |
| excipients to some degree, making complete | | | | unable to do the type of work necessary, |
| extraction difficult. And, once extracted from the | | | | because they do not have the right type of |
| botanical, many constituents will begin to degrade | | | | equipment. Maintaining product form of a whole |
| rapidly making verification difficult, if not | | | | food ingredient requires specialized processing |
| impossible.Clients who have developed dietary | | | | equipment and experience to accomplish proper |
| supplement formulas should consider establishing a | | | | mixing, pasteurization, and maintain product |
| relationship with an independent laboratory that | | | | appearance. It is necessary to have full lab |
| has experience in analytical method development | | | | services on premises.Clients have different needs |
| and validation for natural products. By supplying | | | | e.g speed of turn over, small batch capability. |
| the lab with a sample of each raw ingredient used | | | | Many manufacturers are not geared for this. |
| in manufacturing, the lab can create controlled | | | | Communication |
| mock-ups of the formulation and compare them | | | | Being clear on goals and expectations right from |
| to the finished dosage product. In addition, the lab | | | | the initial stage is critical to avoid problems. Quality |
| can test each single ingredient to see how it | | | | needs to be built in from the initial stages. If the |
| compares to the original supplier's C of A. | | | | client is geared for the cost of quality, it can be |
| Contract labs offer independent verification of the | | | | factored into the margin as well.The customer |
| product's quality. This has become increasingly | | | | must be convinced the contract manufacturer will |
| important in today's industry. | | | | produce the final product to the same |
| Another aspect to quality control is batch lot | | | | specifications as the client's own production |
| testing which ensures quality control at the initial | | | | processes. The supplement manufacturer should |
| level. The potency and purity of herbs depends | | | | be able to provide educational materials to its |
| on the quality of the raw herb used and the care | | | | clients so that they will understand the issues |
| taken in manufacturing. The NNFA GMP program | | | | facing the operation. Supplement manufacturers |
| mandates that all botanical raw materials be batch | | | | need to assure their clients that they have a |
| lot tested for identity every time. They require | | | | strong commitment to customer service, GMP |
| this as well as a number of other protocols | | | | production methods and food safety |
| because of the known lot-to-lot variations that | | | | issues.Confidentiality Agreements will allow for |
| occur in agricultural products.In order to save | | | | free exchange of information and ideas to |
| costs on an independent laboratory analysis of the | | | | develop the optimum product and maximize sales |
| finished product, supplement manufacturers may | | | | for clients. Trust |
| ask their client to depend solely on their | | | | Exercising caution against dishonest business |
| production records to demonstrate that a | | | | practices needs much wisdom and discernment. |
| particular production run was properly prepared. | | | | Trust has become a priceless commodity today. |
| Their records combined with analytical testing of | | | | Clients need to have faith in the manufacturing of |
| the incoming raw materials, may suffice to meet | | | | their products to ensure continued success. |
| the needs of their clients. But trends are changing. | | | | Supplement manufacturers should be open to |
| Quality Control has become extremely | | | | clients visiting manufacturing sites where their |
| important.If there are no quality control measures | | | | products are made. Clients should learn as much |
| established and a consumer survey reveals that | | | | about the process as they can and inspire |
| the label potency claims do not match actual | | | | manufacturers to review manufacturing |
| potency of the product, consumer confidence is | | | | techniques and innovations.Trust means that a |
| lost. To avoid this situation, it is important for | | | | supplement manufacturer will keep confidentiality |
| clients to establish quality control methods early | | | | against the client's competitors, safe-keeping of |
| and request for analytical reports from third party | | | | formulas, produce a well-made product that is also |
| labs that prove that their products are meeting | | | | quality consistent, and keep to delivery schedules |
| label claims before they accept shipment from | | | | with short lead times. These are just some of the |
| the supplement manufacturer. | | | | aspects that will help build trust. |
| Non-Compliance to GMP standards | | | | Mis-Labeling of Health Supplements |
| Numerous companies each year have products | | | | Labels can be misleading. Here are some guidelines |
| recalled due to a lack of GMP protocols in their | | | | to what is legally required. |
| facility. Poor-quality products are a problem. | | | | - Any claim a health supplement manufacturer |
| Consequently, people will not continue to buy | | | | may make must be truthful and not misleading, |
| ineffective products. The health supplement | | | | and the ingredients you use must be safe. |
| industry has begun to call for Good Manufacturing | | | | - A dietary supplement must specifically be labeled |
| Practices (GMPs) on a voluntary and self-enforced | | | | as such, and the label must include information |
| basis. Make sure your supplement manufacturer is | | | | regarding the product's identity, quantity, directions |
| GMP compliant and adhering to its policies. | | | | for use, and manufacturer or distributor. The FDA |
| Although the FDA has yet to finalize the dietary | | | | also requires a Supplement Facts panel, which |
| supplement industry GMPs which were mandated | | | | provides details about the nutritional ingredients |
| in the 1994 DSHEA act, pharmaceutical GMPs | | | | included in the product. |
| have been in place for some time. | | | | - The Dietary Supplement Health and Education |
| Inexperienced Research and Development | | | | Act allow manufacturers to make only general |
| Department | | | | claims about the benefits of their products, called |
| The R&D team should be prepared to work | | | | "structure/function" claims. Examples of such |
| closely with customers to create new | | | | claims include "helps promote healthy skin," "helps |
| formulations or help to expand existing product | | | | improve strength and agility," or "helps improve |
| lines offering suggestions as to what could be | | | | cardiovascular fitness." |
| added to the dosage form in order to enhance its | | | | - All health supplement manufacturers must |
| potential value to consumers. They should be | | | | include a disclaimer that the claim has not been |
| experienced in product development, blending, | | | | evaluated by the FDA and that the product is not |
| packaging and agglomeration.It is important to | | | | intended to treat, cure, or prevent any disease. |
| work with a manufacturer that is familiar with the | | | | Manufacturers must also notify the FDA of their |
| different materials and how they might react with | | | | claim within 30 days of marketing the product. |
| one another so that product integrity can be | | | | And, of course, they must be able to substantiate |
| preserved. This is especially important as | | | | their claim as true. |
| nutritional supplements consist of more complex | | | | |