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