DarshanTalks Podcast

How Do You Register Your New Dietary Ingredient?

If a company is planning to add a new dietary ingredient to their supplement, they must ensure that all FDA regulations are being properly followed. This means notifying the FDA of the new ingredient and going through the registration process and showing that the intended use of the ingredient is safe. The submission process can be difficult to navigate, and companies must remain informed about all aspects of registration to gain FDA approval.

Notifying the FDA

Companies planning on adding new dietary ingredients must first submit notifications to the FDA about their ingredients. In this notification, they must show that the dietary ingredient is reasonably safe for its intended use and that the labeling of the product meets FDA standards. This responsibility falls to the manufacturer or distributor using the dietary ingredient (either on its own or as part of a supplement).

It is also important for companies to determine whether their new ingredients are dietary ingredients or if they are something else entirely. Dietary ingredients include vitamins, minerals, herbs or other botanicals, amino acids, and metabolites. Companies should ensure that their ingredients fall under one of these categories to meet FDA regulations.

What to Submit

The manufacturer or distributor must submit a submission report that includes evidence supporting the safety of the dietary supplement containing the new ingredient. They must provide the report to the FDA at least 75 days before the dietary ingredient’s introduction into interstate commerce (typically before marketing begins). The report must include the company name and address with the name of the new dietary ingredient. The report also must contain a description of the dietary supplement, the level of the dietary ingredient being used in the supplement, conditions for use, history of use, the company responsible for determining the safety, and finally a signature of the person responsible for overseeing the submission process.

GRAS

The FDA has also designated certain substances as “Generally Recognized as Safe” (GRAS). These substances are chemically or pharmacologically similar to FDA-approved ingredients that are already being used in foods. Companies can provide self affirmations that their ingredients are GRAS, and not require pre-market approval from the FDA.

FDA Compliance

Although registering new dietary ingredients may seem relatively simple, there are many important considerations that companies must keep in mind throughout the process. Consulting with a legal expert to help navigate the submission process is crucial for companies looking to bring their supplements to market.If you have questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter,

There are many far-reaching claims being made by cosmetics companies including suggestions that their products are anti-aging, age-defying or revitalizing. The companies are able to do so because the cosmetics industry is largely unregulated by the FDA, allowing misleading claims to go unchecked. This does not mean that cosmetics companies can make false statements in their promotional materials, however--they still must adhere to certain FTC and FDA requirements to stay compliant. 

What Differentiates Cosmetics from Drugs?

Intended Use

Cosmetics are regulated in a different way than drugs, primarily because they are categorized by different intended uses. The FD&C Act defines drugs as being “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” as well as “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” This differs from cosmetics, which are defined by their use as articles “intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body. . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Because drugs and cosmetics have separate intended uses, they are governed by different regulations. While drugs fall completely under FDA oversight, and are subject to strict, rigorous standards, marketing claims for cosmetics are more loosely regulated by the Federal Trade Commission (FTC). 

FDA Requirements

Cosmetics are also held to different FDA requirements than drugs. While drugs must meet safety and efficacy standards, and also demonstrate that they are not misbranded or adulterated, cosmetics primarily need to meet the last two requirements. This means that cosmetics companies must prove that their products are pure, and do not have additional substances diluting them. They must also label their products properly, and not make claims falling outside of the product’s intended use. Efficacy, however, is not required for cosmetics--meaning that cosmetics do not need FDA pre-market approval (except for color additives). As a result, cosmetics are able to reach the market much quicker than their drug counterparts, and are subject to fewer regulations.

Defining Intended Use

For cosmetics, intent is defined by looking at the manufacturer’s claims explicitly promoting a product for a particular use, or by considering the circumstances surrounding the distribution of the product. This means that companies using social media influencers to promote their products should be wary about the statements being used. If a company tells its influencers to make false claims about its product, it could end up violating FTC regulations. Companies should also be cautious about consumer perceptions, or the reason why customers are buying their products. This is yet another factor which can count toward defining a product’s intent. Cosmetics manufacturers should keep both of these factors in mind when advertising their products to ensure they stay compliant with FDA and FTC regulations. 

Are Misleading Claims Allowed?

Although the differences between research and medicine may seem clear, there are many instances in which the two terms are conflated or misused. When considering certain examples, it seems unclear whether research or medicine would be the most appropriate designation. Biohacking, use of stem cells, and use of pharmacogenomics blur the lines between research and medicine. How does one go about differentiating research from medicine?

Generalizable knowledge

One of the key features of research is that it contributes to or develops generalizable (scholarly) knowledge. Any activities falling under this definition may be classified as research–regardless of what they may be labelled. However, research requires adherence to certain regulations including institutional review board (IRB) oversight to ensure that the proposed research methods are ethical. 

Determining when the line is crossed between medical treatment and clinical research can be a difficult task. For instance, if a clinician deals with a single patient and uses a drug off-label during treatment for generalizable knowledge, this act may typically be considered the practice of medicine. However, the instant that a clinician makes generalizable claims about off-label prescriptions, this may constitute research and require IRB oversight.

Intent matters

One way in which we can distinguish research and medicine is through intent. For clinical research, the intention is to answer specific questions through research and potentially benefit future patients and clinical research trials. Medical treatment aims to meet the needs of individual and current patients.

What are the main differences?

Although intent and generalizable knowledge are some key differences between research and medicine, there are several other ways of distinguishing between the two terms. 

Funding

The current patient (or a third-party payer on the patient’s behalf) usually pays for the medical treatment, and drug developers or government agencies typically fund clinical research.

Timeframes

Clinical research is often performed under a protocol, so timelines are very structured, whereas medical treatment typically requires real-time decisions.

Assessment

Clinical research comprises an ongoing, systematic assessment of patient data. In comparison, medical treatment involves an assessment of patient data only when needed.

Guidance

State boards of medicine, professional standards, peer review, informed consent and legal regulations provide guidelines for medical treatment whereas products and procedures regarded as “safe” by the medical community provide the guidelines for clinical research. 

Accessibility

Whereas clinical research is often confidential intellectual property, product labeling makes medical treatment available to the general public.

Publishing

Medical journals typically publish the results of clinical research. However, medical treatments are not generally available to the public.

In Conclusion

Because of the different regulations guiding research and medicine, it is important that companies and individuals learn to distinguish between t...

Dietary supplements and ingredients are required to be registered with the FDA, but the process of registration can be complicated. What should companies keep in mind?

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Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

As more states move to decriminalize cannabis, the regulatory framework becomes more complicated.

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Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

What is the OTC Monograph Process, and why is it important?

Bringing over-the-counter (OTC) drugs to market involves three different pathways, and companies must decide which pathway is most appropriate for them. There are other important considerations, such as which category their OTC drug falls into and which registration they should complete. When attempting to bring drugs to market, companies should consider both the safety and efficacy of their drugs to ensure they are meeting FDA requirements.

Bringing OTC Drugs to Market

The U.S. Food and Drug Administration (FDA) regulates OTC medicines, but specifically, the FDA’s Office of Nonprescription Drugs reviews OTCs. They look for include consumer studies and post-marketing safety data, labeling of products and potential regulatory issues among other quality points. This division is mainly looking to ensure that OTC drugs are safe for consumers and show efficacy.

There are three accepted pathways to bring OTC drugs to the market. One of these pathways is the New Drug Application through which drug sponsors can offer a new pharmaceutical to the FDA for sale in the U.S. Another pathway is by converting a prescription drug into an OTC medicine in an “Rx-to-OTC switch.”  The FDA permits this where they deem that the prescription medicine is safe and effective enough to be marketed as an OTC drug. Another pathway is through an OTC monograph, which allows for OTC drugs to be sold without individual product licensing.

OTC Historical Background

In 1938, there was no in-depth review process for OTC drugs. Instead, the FDA only looked to ensure that OTC drugs were meeting their safety standards. This changed in 1962, when the Kefauver-Harris Amendments provided stronger guidelines for the FDA to follow and implemented efficacy standards that drugs had to meet. In 1972, the official OTC review process was set up and placed OTC drugs into one of three different categories:

1) GRAS, or Generally Recognized As Safe and effective for intended use; 2) non-GRAS; 3) requiring more data. 

After the FDA had established these categories, they moved on to publishing a final monograph that codified acceptable ingredients, formulations and labeling. This monograph allowed for any OTC medicine that fit the accepted standards to be manufactured and directly brought to market without individual licensing.

Registration

Once companies have chosen an appropriate pathway for their drug, they must ensure they are getting the registrations for their drug. This means verifying that the process requires them to register their manufacturing facilities. Depending on where the drugs are being manufactured, companies may also need to look at state level registrations. Most states require that companies register with them as a distributor, manufacturer or wholesaler. Depending on the state, this may or may not be necessary.

FDA Compliance

Although bringing OTC drugs to market may seem relatively simple,

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There is growing pressure from patients to make healthcare more transparent. However, there remain privacy concerns about publicizing clinical research data.

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Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

Setting up compliant investigational drug pharmacies means reviewing FDA requirements and ensuring regulations are being met.

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Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

The FDA has changed its approach when enforcing compliance for nicotine and cannabis products. Whereas previously the FDA was practicing enforcement discretion, often limited by the lack of guidance and will, the FDA is slowly solidifying its stance on how it will regulate vaping products, CBD products and pharmaceuticals. As a result, companies in FDA regulated companies are forced to scramble as the consequences of not following regulations leave them exposed to administrative penalties, fines or even criminal prosecutions. 

Increase in warning letters

When examining the FDA’s most recent enforcement actions, it appears that the FDA targets companies based on how they frame the intended use of their products. The intended use of a product is determined by looking at the product labeling and also the claims and advertising materials accompanying the product. Companies must be cautious when promoting their products to ensure that they do not produce products that are adulterated, misbranded or unsafe. 

The FDA has been issuing warning letters much more frequently, particularly as CBD and vaping products become more popular. In 2017, for instance, the FDA only issued five warning letters. However, enforcement in 2019 increased so much that one letter has been issued per month in the last three months. There has been a similar uptick in enforcement trends around the promotion of vaping and cannabis.

Effects on nicotine and CBD industries

The United States House Committee on Appropriations recently stated that it expects the FDA to identify lawful regulatory pathways for CBD foods and dietary supplements. These pathways would include safety parameters such as labeling requirements and limitations on CBD quantities to protect public health. The committee has also said that the FDA needs to preserve the integrity of its drug development and approval process to ensure drug products are going through validation processes, and have been tested for safety, quality and efficacy. Overall, the committee has significantly pressured the FDA to speed up their regulatory process and develop their stance on vaping and cannabis products. This may be a difficult undertaking, as FDA Chief Information Officer, Dr. Amy Abernethy, has estimated that it may end up taking up to five years to generate a complete regulatory framework for CBD.

The dangers of inappropriate promotion

Vape Companies

Although recent updates in the law suggest that evidence of off-label intended marketing may not be inherently illegal, it can still lead to civil, criminal or administrative penalties. This is where some companies go wrong–they may speak off-label and end up violating FDA mis-branding provisions. This was the case for multiple vaping companies, including Juul, which ended up being penalized for their relationship with social media influencers. Influencers neglected to include mandatory warnings in their posts about nicotine in vape and violated FDA regulations.