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Nutraceutical Law

Over the past few years, an increasing number of dietary supplements have become available in supermarkets, Amazon, online and brick and mortar health food stores and they are also available for purchase in pharmacies. The term “nutraceutical” is used to describe these therapeutic or nutritionally functional foods. Nutraceuticals, which have also been called medical foods, designer foods, phytochemicals, functional foods and nutritional supplements, include such everyday products as “bio” yoghurts and fortified breakfast cereals, as well as vitamins, herbal remedies and even genetically modified foods and supplements. Many different terms and definitions are used in different countries, which can result in mass confusion.

The term “nutraceutical” was coined in 1989 by Stephen De Felice, founder and chairman of the Foundation for Innovation in Medicine, an American organization which encourages medical health research.[1]

The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) share corresponding authority over the promotion of certain products, including drugs, dietary supplements, food, medical devices, and cosmetics. The two agencies operate pursuant to a 1971 Memorandum of Understanding (“MOU”), under which the FDA exercises primary responsibility for regulating the labeling of these products, as well as the advertising of prescription drugs, while the FTC has primary responsibility for enforcing laws against false or misleading advertising for all non-prescription drug products.

We assist clients who want to manufacture and distribute nutraceuticals (supplements or vitamins) so that they stay on the right side of the fence in terms of claims and public expressions. This also extends to spas and clinics who provide alternative modalities that are not FDA approved or have not provided any evidence based review for the scientific evaluation of health claims.

Our guidance helps companies who distribute products to the general public maintain a healthy relationship with the U.S. Food and Drug Administration (FDA) regarding regulations on good manufacturing practices (CGMPs) for dietary supplements.

In 2015, the FDA issued 80 Warning Letters (WLs) to dietary supplement (DS) companies. This was a 12.68% increase on the 71 issued in 2014. The could in part be credited to a large number of WLs issued to companies marketing products adulterated with non-dietary ingredients such as beta-methylphenethylamine (BMPEA) and 1,3-dimethylbutylamine (DMBA).

We work with many professional teams to patent formulations as well as provide FDA label review before going public and getting shot down or a Warning Letter (WL) from the FDA. This also includes setting up SOPs (standard operating procedures); the most common cGMP (Good Manufacturing Procedures) citation in Warning Letters issued to the dietary supplement industry is a lack of procedures and records. Then there are specifications, master manufacturing and batch production records and testing so that some form of procedures/process has been conducted.

If you're starting a new line of supplements just a few of the considerations are outlined in this list:

  1. Determining market needs and desired product claims.
  2. Ingredient screening.
  3. Proposing multiple formulations to fit market needs and desired product claims, as well as budget.
  4. Requesting multiple quotes.
  5. Selecting a manufacturer and auditing.
  6. Creating product specifications.
  7. Logo and compliant label design.
  8. Structure/function claims drafting, substantiating, and submitting.
  9. Creating a set of SOPs.
  10. Creating advertising copy.
  11. Facilitating finished product testing.
  12. And likely more.

There are certain claims unscrupulous marketers of products make that disrupts the industry for honest manufacturers and distributors. A few companies that have been recently cited were claiming products could treat the following (number indicates the number of website/LinkedIn/Facebook etc. under investigation). As you can imagine there are numerous ones out there that provide ridiculous claims for weight loss or ED (erectile dysfunction).

Inflammation – 8
Cancer – 8
Arthritis – 7
Diabetes – 6
Blood pressure – 6
Pain – 5
Cholesterol – 5
Antimicrobial – 5
Asthma – 4

Three quick tips you can use to clean up your marketing claims and hopefully avoid an FDA Warning Letter for your product or treatment is.

  1. Remove all explicit claims. The FDA most often points out explicit disease claims, rather than implied disease claims.
  2. If you are marketing a product in one of the nine categories listed above (cancer, inflammation, pain, etc.), make those products your priority for cleaning up claims.
  3. Learn the codified definition of disease, as well as the criteria for structure/function claims, and refer to both frequently.

This is an attempt to scratch the service of a very vast and interconnected industry that reports to do several billion dollars a year and can be lucrative; you just have to start out the gate with the proper funding, strategy and ongoing compliance.

[1] Jack DB. Keep taking the tomatoes - the exciting world of nutraceuticals. Mol Med Today 1995:118-21.