Nutritional, or “dietary,” supplements are products that the manufacturer represents as having the ability to cure, treat, or prevent diseases or other health conditions, e.g., depression. Under the federal Food, Drug, and Cosmetic Act (FDCA), these products are subject to the same legal requirements that apply to drugs, even if they are labeled as dietary supplements. This means that, among other things, their effectiveness has to be proven scientifically.
In addition, a manufacturer and distributor should establish what the proper dosages are for nutritional supplements. They should also establish how they could interact with approved medications or other substances and whether they have negative side effects or present safety concerns.
In general, consumers should be careful of products marketed and sold online or in retail stores with unproven claims to prevent, treat, or cure diseases. The Food and Drug Administration (FDA) is responsible for enforcing the FDCA. The FDA advises consumers to consult their doctor or a pharmacist before using nutritional supplements or drugs.
For example, some supplements might have negative interactions with medicines or other supplements that a person might be taking.
There are many nutritional supplements on the market. Some of them closely resemble the effects and results of anabolic steroids. They are considered to be performance-enhancing drugs. Additionally, there are several supplements that proposed legislation that may soon make some illegal nutritional supplements. Or they might be available only with a prescription from a licensed medical doctor.
Which Supplements Might Be Outlawed?
The following is a list of nutritional supplements that are under review and may soon be made illegal:
- DHEA: DHEA is a hormone produced naturally by the human body. DHEA aids in the production of other hormones in the body, including testosterone and estrogen. A person’s production of DHEA peaks in early adulthood and then decreases as they grow older.
- Consumers can buy a synthetic version of DHEA as a tablet, capsule, powder, topical cream, or gel. People use it as a treatment for the effects of aging and to improve physical performance. It is also used to treat depression and the symptoms of menopause;
- 7-keto DHEA: 7-keto-DHEA is not like regular DHEA because it is not converted to steroid hormones such as androgen and estrogen. Consuming 7-keto-DHEA or applying it to the skin as a cream or gel does not increase the level of steroid hormones in the blood. People take 7-keto-DHEA to treat obesity, anxiety, depression, and other symptoms. Some people take it to increase muscle strength.
- However, the scientific evidence that would prove this has not been produced;
- Pregnenolone: Pregnenolone is yet another chemical in our bodies that plays a role in the production of steroid hormones. It can also have an effect on other chemicals in the brain, and it is thought that it may have a role in some psychiatric illnesses.
- It can also be manufactured in a laboratory. People use it as a medicine to treat bipolar disorder, autism, schizophrenia, back pain, and many other conditions. However, these uses are not supported by good scientific evidence;
- Androstenedione: Androstenedione is now a Schedule II Controlled Substance per federal law, and it is not legal to use it in nutritional substances. The body produces Androstenedione in the testes, ovaries, and adrenal glands and converts it to other sex hormones, including testosterone and estrogen. Less is produced as a person ages, especially after a person turns 30.
- People use Androstenedione to strengthen their muscles, improve athletic performance, fight fatigue, and treat many other conditions, but there is no good scientific evidence to support these uses. It might, in fact, be unsafe.
In spite of the fact that it is illegal, it is still used in nutritional supplements, especially those marketed as good for building muscle mass and strength and improving athletic performance. The use of Androstenedione has been prohibited by the National Collegiate Athletic Association (NCAA).
It is important not to confuse Androstenedione with other substances such as:
- 1-Epiandrosterone; and
Other controlled substances used as supplements are anabolic steroids, Ketamine, and testosterone.
What Are the Federal Penalties for Selling Nutritional Supplements?
The punishment for selling a Schedule III controlled substance is a maximum term of imprisonment of 5 years and payment of a fine of up to $15,000. Possession only of a Schedule III substance is punishable by a maximum of 1 year in jail and a fine of no more than $5,000.
In some states, e.g., Pennsylvania, a person’s driver’s license is also suspended if they are convicted of possession. The term of the suspension depends on whether the offense is a first, second, or third, or subsequent as follows:
- First offense: 6 month;
- Second offense: 1 year;
- Third offense: 2 years.
However, many of the supplements are not controlled substances yet.
If a consumer has used a nutritional supplement and believes that it may have caused some type of reaction or illness, they want to stop taking it and consult their health care provider. The FDA also encourages healthcare professionals and consumers to report adverse reactions associated with FDA-regulated products to the FDA.
When the FDA learns that nutritional supplements may have caused consumers adverse reactions and are being sold in violation of the FDCA, it can send out warning letters to the companies that are illegally selling them.
The FDA then requests that the companies provide the FDA with information that addresses the issues with which it is concerned. These issues again are what the property dosage is and how the companies can show that the supplements are effective for their intended purpose.
Basically, the companies must produce evidence to show why they think their products are not in violation of the law. If a company fails to correct any violations of the law, the FDA may take legal action against them. It might seize the product. It might seek an injunction from a court ordering the company to stop manufacturing and/or distributing the supplement.
The fact is, however, that sometimes nutritional supplements are still legal, and there are no federal laws that explicitly prohibit their use or sale. Although, there may be regulations against the distribution of such supplements.
Still, if a person believes they have been harmed by using a nutritional supplement, they would consult a personal injury lawyer to see if they might have cause for a lawsuit claiming negligence or strict product liability against the manufacturer and distributor of the supplement.
In 1994, Congress adopted the Dietary Supplement Health and Education Act (DSHEA) as law. It gives the FDA authority to regulate dietary supplements. However, DSHEA does not require dietary supplement companies to register their products with the FDA.
This oversight seriously limits the FDA’s ability to properly regulate the market. This can be seen from the fact that there are between 50,000 and 80,000 dietary supplements for sale in the U.S. today. More than 75% of Americans use dietary supplements, and the value of total annual sales is over $50 billion dollars.
The Dietary Supplement Listing Act of 2022 is federal legislation that has been proposed. It would require the manufacturers of nutritional supplements to provide the FDA with the information about their products that it needs to engage in better regulation. The information reported to the FDA would be made public to Americans.
Additionally, there is proposed legislation in the form of the “Anti-Andro Bill.” This bill is supposed to address the increase in supplement use among teens. This law, if passed, would list certain nutritional supplements as Schedule III controlled substances. The possession and use of nutritional supplements would then be criminal offenses, as is the possession and use of steroids.
Are There State Penalties for Using or Selling Nutritional Supplements?
Because many nutritional supplements are currently legal, there are no penalties for their use or sale. Keep in mind, however, that similar to federal law, there may exist limits and penalties for improper distribution. Of course, if a supplement contains a controlled substance, a person could face punishment under state law for possession or distribution.
California has recently decreed more stringent warning labels for these types of supplements. For now, there is legislation that deems the sale or possession of some specified supplements as either a misdemeanor or felony. For the type of supplement that carries an age limit, there may be fines or other punishment for the sale or distribution to minors for those drugs.
Do I Need the Help of a Lawyer for My Nutritional Supplement Issue?
If you have been charged with possession or sale of a controlled substance, you want to consult a drug lawyer.
LegalMatch.com can connect you to a criminal defense lawyer with experience in defending people who have been charged with drug offenses. Your lawyer will be able to tell you if you have any defenses available to you.
If you believe that you have been harmed by your use of a nutritional supplement, you want to consult a personal injury lawyer. LegalMatch.com can also connect you with an experienced personal injury lawyer. Your lawyer can review the facts of your situation and tell you if you have a claim against the manufacturer or distributor of the supplement for strict product liability or negligence.