With so many medicines and supplements on the market today, it’s more important than ever that they are created with exacting standards and tested to avoid unknown risks, like side-effects or contraindications in relation to other drugs, supplements, foods, or medical procedures.
While there are plenty of government regulations and standards for those who make pharmaceutical drugs, it is more difficult for dietary supplement makers to refer to well-established guidelines. Consequently, if you are a manufacturer of dietary supplements, you’re generally not obligated to prove that your supplement is safe before it goes on the market. However, the FDA will act if your supplement is found to be unsafe when it is already on the market, either requiring the product to be recalled or a warning issued, this may cause all sorts of problems for your company. Besides the financial loss, you will lose consumer trust and your sales will plummet.
For this reason, as a supplement manufacturer, the burden of proof is on you as to whether or not your label claims, website information, and advertising is accurate and truthful. With that in mind, here are some guidelines on how you can produce the highest-quality products for consumers without risking censure by the FDA for making a mistake in your research, product manufacturing, labeling, product descriptions, or advertising.
- Ensure perfect laboratory conditions.
The first step, of course, when setting up your laboratory is to invest in a fully-equipped one. Refuse to compromise when it comes to choosing the best equipment in the marketplace. Although some equipment may stretch your budget and cheaper substitutes are available, buying inferior quality will not benefit your company in the long run. This is especially true if you perform testing on material that needs exacting temperature tolerances.
Next, you will need to hire well-educated and highly-skilled people to staff your laboratory. For this, you will need to work with highly skilled human resources personnel and recruiters to get the right people on board. While qualifications are important, the right candidates will also show signs of having high character and scientific discipline. Still, despite these practical measures, laboratory conditions can be compromised if you are forced to switch locations. Usually, when this happens, it is quite unexpected and takes everyone by surprise. This change in location can occur for a variety of reasons, perhaps due to a change in funding, sponsorship, or other financial factors. In order to ensure that you pick up exactly where you left off so that none of your work is wasted or your experimental data is compromised, it’s advisable to choose highly professional lab movers with an excellent reputation.
- Offer clear, unambiguous information on labels, your website, and in your advertising.
If you are marketing dietary supplements, like vitamins, minerals, herbs, or botanicals, you should specify what you recommend when it comes to defining dosages. Often individuals keen to improve their health or optimize their performance tend to overdo a good thing or consume it with foods that diminish efficacy. So, working within government guidelines on what you can and cannot say, try to be as lucid as possible.
- Work with recognized scientific, medical, or government authorities to clarify how to safely promote your products.
Since your product will not require a prescription, consumers are likely to self-diagnose their health conditions. By working with doctors, scientists, and health care providers, you will be able to provide more reliable information to consumers about how they can achieve optimal health by taking your dietary supplements in the right way. For instance, clarify what food or medicine combinations to avoid when taking your supplements. In fact, the more advanced your supplement happens to be, the more effort you need to make to prove that all your claims about it are scientifically verifiable.
- Base your work on scientific evidence.
Scientific evidence that supports your dietary supplement may be available in abundance. For instance, the value of vitamins and minerals are well-established as a way to support certain health conditions. However, the field of nutrition has not been fully mapped out, and with more exotic supplements, further study may be necessary. Consequently, you should, if possible, lean towards manufacturing products that are backed by a lot of scientific evidence rather than venture into producing supplements where there are few studies or the studies tend to be inconclusive when it comes to recognizing benefits.
In conclusion, your work as a manufacturer of dietary supplements is not easy. There are many possible mistakes you could make when it comes to building a flourishing company. Despite your best intentions, consumers may misuse how the product is to be used, scientific evidence may refute the claims you are making, or you may be accused of false advertising because of unexpected side-effects. Following these four suggested guidelines will increase your odds of building a flourishing company.